Promoting Cancer Screening among the First-Degree Relatives of Breast and Colorectal Cancer Patients: The Design of Two Randomized Trials

Preventive Medicine 28, 229–242 (1999) Article ID pmed.1998.0408, available online at http://www.idealibrary.com on

Promoting Cancer Screening among the First-Degree Relatives of Breast and Colorectal Cancer Patients: The Design of Two Randomized Trials Alfred C. Marcus, Ph.D.,*,1 Dennis Ahnen, M.D.,† Gary Cutter, Ph.D.,* Ned Calonge, M.D.,‡ Sarah Russell, B.A.,* Scot M. Sedlacek, M.D.,* Marie Wood, M.D.,§ David Manchester, M.D.,¶ Lynda Fox, J.D.,| Worta McCaskill-Stevens, M.D.,** Diane Fairclough, Dr.P.H.,* Steve Hines, M.P.H.,* Lari Wenzel, Ph.D.,* and Kyle Osborn, B.A.†† *AMC Cancer Research Center, 1600 Pierce Street, Denver, Colorado 80214; †University of Colorado Cancer Center and Department of Veteran Affairs, 1055 Clement Street, Denver, Colorado 80220; ‡Kaiser Permanente, 10350 East Dakota Avenue, Denver, Colorado 80231; §University of Vermont, 111 Colchester Avenue, Burlington, Vermont 05401; ¶The Children’s Hospital, 1060 East 19th Street, Denver, Colorado, 80218; |Eleanor Roosevelt Institute, 1899 Gaylord Street, Denver, Colorado 80206-1210; **Indiana University Medical Center, 535 Barnhill Drive, Indianapolis, Indiana 46202; and ††University of Colorado Cancer Center, 4200 East 9th Avenue, Denver, Colorado 80262

Background. In this paper two large nationwide trials are described, both of which will test a comparable telephone-based counseling intervention to promote cancer screening among the first-degree relatives (FDRs) of breast and colorectal cancer patients. The unit of randomization will be the family unit of eligible FDRs. Access to FDRs will be obtained from their relatives with cancer. Selected intervention and design issues are reviewed, including how both projects will respond to FDRs who exhibit significant levels of cancer-specific anxiety or distress and how potential highrisk cancer families will be accommodated. Methods. Pursuant to the development of both studies, two feasibility surveys were conducted to determine whether patients would grant access to their FDRs and whether the FDRS identified by these patients would be receptive to the telephone intervention. Results. Approximately 80% (106 of 132) of breast cancer patients agreed to provide access to their eligible FDRs when contacted on-site at participating hospitals and clinics. Of those subsequently selected for telephone follow-up (n 5 95 or 90%), 80% (n 5 76) were successfully contacted by telephone, and of these 97% (n 5 74) provided the names and telephone numbers of their FDRs. Among colorectal cancer patients contacted on-site (n 5 46), 96% (n 5 44) agreed to provide

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access to their FDRs, and of those contacted by telephone (n 5 33 or 75%), 91% (n 5 30) provided the requested information about their FDRs. Once contacted, 95% of breast cancer FDRs (55 of 58) and 91% of colorectal cancer patients (51 of 56) endorsed the intervention strategy. Conclusions. It is argued that this intervention, if proven effective, could provide an exportable strategy for reaching large numbers of high-risk individuals to promote cancer screening. q1999 American Health Foundation and Academic Press

Key Words: cancer/prevention and control; cancer screening; health education.

INTRODUCTION

Two major sources of cancer mortality in this country are breast and colorectal cancer. Breast cancer is the second leading cause of cancer death among U.S. women. In 1998, nearly 180,000 women will be diagnosed with breast cancer, and approximately 43,000 are expected to die from this disease [1]. Colorectal cancer is the second leading cause of cancer death in the United States for men and women combined. In 1998, over 130,000 individuals are expected to be diagnosed with colorectal cancer, and over 55,000 will die from this disease [1]. Taken together, breast and colorectal cancer are expected to account for nearly 18% of the total cancer mortality burden in the United States. One of the most compelling and controversial scientific developments in recent years has been the discovery of inherited genetic mutations that predispose to

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0091-7435/99 $30.00 Copyright q 1999 by American Health Foundation and Academic Press All rights of reproduction in any form reserved.

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hereditary breast and colorectal cancer. As much as 5–10% of all breast cancers may be attributed to inherited mutations in the breast cancer susceptibility genes BRCA1 and BRCA2 [2–5]. However, more recent studies suggest that the percentage may actually be lower [6,7]. Further, only a subset of hereditary breast cancer families has been found to harbor mutations in their genes [8], thus suggesting the existence of other unidentified breast cancer susceptibility genes. Two types of colon cancer, familial adenamatous polyposis and hereditary nonpolyposis colon cancer, have been linked to germ line mutations that may account for about 5% of the overall incidence of colon cancer [9–12]. Although hereditary cancer is relatively rare, first-degree relatives of breast and colorectal cancer patients may have a moderately increased cancer risk. It has been estimated that the presence of a single first-degree relative (FDR) with breast cancer increases a woman’s breast cancer risk by 70% [13,14], which is the same increase in colon cancer risk attributable to having one FDR with colon cancer [15]. One major challenge to cancer control is that despite the availability of “consensus-approved” screening tests for both breast and colorectal cancer, screening rates among the FDRs of these cancer patients remain substantially below recommended levels. For example, among women with a family history of breast cancer, including the FDRs of breast cancer patients, estimates of obtaining a recent mammogram typically range between 30 and 60% [16–30]. Of special note is the finding that high levels of psychological distress among the FDRs of breast cancer patients may impede screening for breast cancer [22,31,32]. According to the U.S. Preventive Services Task Force recommendations [33], fecal occult blood tests (FOBT) should be obtained annually, while the periodicity of sigmoidoscopy (as an alternative to FOBT) was not specified. With respect to annual or regular FOBTs, several studies suggest that adherence rates may be as low as 20% among the U.S. adult population and lower still for ever having had a sigmoidoscopy [34,35]. The best available evidence suggests that individuals with a family history of colorectal cancer (including FDRs) are also substantially underscreened [36–54], with participation in screening programs rarely exceeding 40–50% [37,38,40,43,44,46–51,54]. In this paper, we describe the design of two ongoing nationwide trials that will test a telephone counseling intervention to promote cancer screening among the FDRs of breast and colorectal cancer patients. Results from two feasibility surveys, one targeted to cancer patients, the other to the FDRs of these patients, are also reported. The results of both surveys underscore the potential value and feasibility of the intervention being tested. During the design and pilot-testing phase of both studies, several key issues confronted the research

team, as well as the Institutional Review Boards at the collaborating institutions. These issues are also described as well as how these issues were resolved within the context of the two randomized trials. It is hoped that the conceptualization and refinement of the intervention protocols in these two studies will benefit program planners who may one day implement similar cancer screening programs for high-risk populations. OVERVIEW OF STUDY DESIGN

The ongoing program of research described herein was funded by the National Cancer Institute (NCI) in response to a solicitation for grant applications to establish Cancer Prevention Research Units (CPRU) [55]. One project targets the FDRs of breast cancer patients, while the second project targets the FDRs of colorectal cancer patients. The behavioral goal of the breast cancer screening project is to increase the percentage of FDRs, 401 years of age, who report annual mammograms and clinical breast examinations. For the colorectal cancer screening project, the goal is to increase the percentage of FDRs, 401 years of age, who report annual FOBTs and/or a sigmoidoscopy beginning at age 40 and every 3 to 5 years thereafter. The two component projects will share the same basic intervention protocol (telephone counseling with a follow-up mailout) and research design (randomized two-group design). These common design elements will provide a key opportunity to compare the efficacy of the intervention across the two main target groups in the CPRU (i.e., the FDRs of breast and colorectal cancer patients). As shown in Fig. 1, FDRs will be identified by their relatives who have been diagnosed with breast or colorectal cancer within the past 12 months. Over 15 hospitals nationwide will participate in this study by providing access to their breast and colorectal cancer patients. All participating institutions are associated with one of three NCl-funded clinical cooperative groups: the Eastern Cooperative Oncology Group, the Southwest Oncology Group, and the North Central Cancer Treatment Group. In the vast majority of these institutions, eligible patients will be identified using hospital tumor registry lists or pathology reports, both of which contain patient addresses and telephone numbers. For patients identified in this fashion, initial contact will occur by mail and will include an introductory letter and brochure that describes the study in more detail. Patients will be told in the letter that their physician approved the mailout and endorses the study (prior physician approval will be obtained for all patients, and the name of the physician will be highlighted in the letter) and that the major goal of the study is to “better understand the impact of cancer on families.” Patients will also be told that we will ask them for the names and addresses of their eligible relatives. The letter will specify that

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FIG. 1. Overview of research design common to both component projects.

their relatives can live anywhere in the country and must be between the ages of 40 and 75 and that those relatives who choose to participate will be interviewed over the telephone about their experiences with cancer in a close family member. Also included in this initial mailout will be a specific request to conduct a telephone follow-up interview with the patient to obtain a roster of their eligible FDRs. Informed consent to conduct the interview will be obtained using a bounce-back participation card with a stamped return envelope that will provide patients with three options to choose from: (1) the patient can give permission to be interviewed, (2) the patient can decline to be interviewed, or (3) the patient can indicate he/she has no age-eligible FDRs. If no bounce-back card is received within 14 days, a telephone interview will be

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attempted with the patient, at which point verbal informed consent will be obtained. In a few cases, particular physicians or clinics have expressed a preference to initially approach patients on-site during a physician visit. In these situations, the study brochure will be given directly to the patient, and written informed consent to complete the telephone follow-up interview will be obtained at that time using a modified version of the previously described participation card. The telephone follow-up interviews with patients are primarily intended to obtain a list of eligible FDRs who can then be approached for study enrollment. Among the key eligibility criteria for FDRs are the following: (1) the FDR is age-eligible, (2) the FDR is already aware of the cancer diagnosis in the patient (this will be determined by asking a specific question of the patient for each age-eligible FDR), (3) the patient has given the study team permission to contact the FDR, and (4) the FDR lives in the United States and speaks English. In addition, patients will be asked during these interviews to identify which of their first-degree and selected second-degree relatives (i.e., the FDRs of all affected FDRs) have cancer now or had cancer in the past (including cancer site if known). Once informed consent is obtained from patients to contact their eligible FDRs, the family unit of eligible FDRs will then be randomized to the intervention or control arm of the study. Randomization of family units rather than FDRs will occur to avoid potential contamination (e.g., if individuals were randomized within family units, intervention FDRs might talk with other family members, including those assigned to the control condition, about the content and key educational messages included in the intervention). After informed consent and the family roster of eligible FDRs are obtained from patients, letters introducing the project will be mailed to all eligible FDRs inviting them to participate. This advance mailout will include a brochure explaining the study and a bounceback participation card which relatives can use to decline participation. Relatives who decline by mail will be removed from the sample pool. The remaining FDRs will be contacted by telephone 2 weeks after the mailout. The telephone interviewers will obtain informed consent from the FDRs after explaining how their names were obtained from their index cases. The FDRs will also be told prior to receiving informed consent that the investigators “are interested in learning more about how cancer affects the lives of others in the family.” Following informed consent, FDRs will then receive a 25- to 30-min core baseline interview to assess sociodemographic information about the subject (e.g., age, race, health status, education, income, medical insurance), health beliefs related to breast/colorectal cancer (e.g., perceived susceptibility, self-efficacy in obtaining the recommended cancer screening tests, perceived efficacy

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of selected cancer screening tests), anxiety about breast/ colorectal cancer, and both past and current cancer screening practices. For control subjects, the baseline interview will end at this point. For intervention subjects, the baseline interview will continue for another 5–10 min, with tailored telephone counseling to promote cancer screening. Intervention subjects will also receive a tailored follow-up letter that focuses more specifically on their FDR status and the specific barriers to cancer screening identified in the expanded baseline intervention interview. All subjects will then receive 3- and 12-month follow-up telephone interviews to assess cancer screening practices and related attitudes and beliefs. For the breast cancer screening project, the accrual goal is to enroll 905 breast cancer patients, which is then expected to yield (based on data obtained from a feasibility study described below) approximately 1,810 eligible FDRs (i.e., 2.0 eligible FDRs per patient). For the colorectal cancer screening project, the accrual goal is to enroll 800 colorectal cancer patients, which should yield approximately 2,470 eligible FDRs (also based on estimates obtained from the feasibility study described below). These sample sizes will be sufficient to reject the null hypothesis if group differences of 10 percentage points or greater are obtained in rates of cancer screening (i.e., percentage reporting a screening mammogram in the past 12 months; percentage reporting a FOBT in the past 12 months or a sigmoidoscopy in the past 3–5 years). DESCRIPTION OF TELEPHONE COUNSELING INTERVENTION

The overall development of the intervention was guided by several theoretical models. The assessment

of cancer screening practices draws upon the Transtheoretical Model, which assumes that behavior change progresses and recycles through a series of stages [56– 58], including precontemplation (no previous history of screening and no plans to become adherent), contemplation (no previous history of screening, but plans to become adherent), action (adherent only in most recent recommended screening interval, and plans to remain adherent), relapse (previous history of screening, currently not adherent, and no plans to become adherent), and maintenance (has demonstrated adherence over two successive recommended screening intervals and plans to remain adherent). Table 1 provides a more detailed description of these various stages of change. Two of the main variables that will be used to define stage (i.e., whether the subject is currently adherent and whether the subject has future plans to become or remain adherent) will also be used to tailor information provided as part of the telephone counseling intervention. In addition, the intervention also reflects elements of the Health Belief Model [59,60], especially with respect to the interactive barriers counseling component of the intervention (described below), as well as the Theory of Reasoned Action, with its emphasis on behavioral intentions [61]. Finally, the emphasis on message reinforcement and promoting self-efficacy in the design of the intervention reflects the contributions of Social Cognitive Theory [62,63]. A central feature of the CPRU is the adaptation of these theoretical models to an intervention that will be delivered primarily over the telephone. It is important to note in this regard that there is a large body of evidence to support the use of the telephone in behavioral research. For example, telephone counseling of medical patients (i.e., “telemedicine”) is well established in the literature [64–76], including psychosocial

TABLE 1 Definitions of Stages of Change Stage Precontemplator Contemplator Action

Maintenance

Relapse risk

Relapse

Breast cancer screening study

Colorectal cancer screening study

No previous history of mammograms and no plans to obtain mammogram in next 6 months No previous history of mammograms but intends to obtain mammogram in next 6 months Has been adherent during most recent recommended screening interval (annual mammograms) and intends to remain adherent Has been adherent during two most recent recommended screening intervals (two consecutive annual mammograms) or longer, and intends to remain adherent Currently adherent (mammogram past 12 months) but intends to become nonadherent during next recommended screening interval Has been adherent in past but is currently nonadherent and intends to remain nonadherent

No previous history of colorectal screening and no plans to obtain FOBT or sigmoidoscopy in next 6 months No previous history of colorectal screening but intends to obtain FOBT or sigmoidoscopy in next 6 months Has been adherent during most recent recommended screening interval (FOBT 5 annual; sigmoidoscopy 5 every 3–5 years) and intends to remain adherent Has been adherent during two most recent recommended screening intervals (FOBT 5 annual; sigmoidoscopy 5 every 3–5 years) and intends to remain adherent Currently adherent (either FOBT or sigmoidoscopy) but intends to become nonadherent during next recommended screening interval Has been adherent in past but is currently nonadherent and intends to remain nonadherent

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needs assessment and counseling that specifically targets cancer patients and other cancer-relevant populations [77–93]. The specific telephone counseling protocol to be tested in this program of research is shown in Fig. 2. As indicated, the intervention will provide general information about the value of cancer screening for the FDRs of breast and colorectal cancer patients. In addition, telephone counselors will provide information that is tailored to the subject based on whether the FDR is currently adherent to the recommended cancer screening guidelines and whether the FDR plans to obtain the screening test within the recommended time interval. This information will be obtained from the core baseline interview that is completed by both intervention and control subjects. The use of CATI will allow easy retrieval of this information and automatic branching within the intervention interview so that counselors need only read or paraphrase the text fields as they appear on the computer screen. Illustrative examples of how this information will be tailored are presented in Table 2. Of special note are two general principles of tailoring messages to subjects. First, among subjects who are not currently adherent and/or do not plan to become or remain adherent, more

FIG. 2. Scheme of telephone counseling interview for FDRs of breast cancer patients.

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emphasis will be given to informational and motivational messages to promote behavior change, including information about family history as a risk factor and the efficacy and value of screening. The second principle of tailoring has to do with the emphasis placed on pro vs con messages. Pro and con statements are conceptualized as mediating variables that are predictive of stage of change within the context of the Transtheoretical Model [94–96]. Thus, they roughly translate into anticipated gains (pros) and losses and/or barriers (cons) for a particular behavior. Previous research has shown that pros and cons may have a differential effect depending on stage of change. This differential effect has been termed the “crossover” principle in which increasing the pros of the target behavior will be most beneficial in moving people from precontemplation to contemplation, while decreasing the cons will be most beneficial in moving people from contemplation to action [95]. This crossover principle can be seen in Table 2 with the differential emphasis placed on gain (pro) and loss (con) messages. Also shown in Table 2 are tailored messages to promote self-efficacy. Thus, if the subject is currently adherent, this behavior will be reinforced to promote selfefficacy. If, on the other hand, the subject is not currently adherent, self-efficacy will be encouraged by reminding subjects of their prior screening behavior (if applicable) or by emphasizing the ease with which the recommended test(s) can be obtained. Similarly, future intentions to obtain the designated cancer screening tests will be used to either reinforce these intentions if they are supportive of screening or to encourage the subject to reconsider their plans if they intend to remain nonadherent or relapse. Also of note is the interactive barriers counseling component of the intervention. To elicit barriers to cancer screening, FDRs will be asked a series of Likerttype questions. For the breast project, the pros and cons statements developed by Rakowski et al. [97] will be used for this purpose. For each response indicating disagreement with a pro statement or agreement with a con statement for the target behavior (e.g., cancer screening), a scripted message will then appear on the computer screen to facilitate the counselor’s response. Selected examples of the interactive barriers counseling protocol are shown in Table 3. For colorectal cancer screening, there has been very little developmental work regarding the assessment of pros and cons. Thus, these Likert-type questions will be developed specifically for this project. Pursuant to this task, a series of four focus groups was conducted with the FDRs of colorectal cancer patients. Among the barriers identified by this process were the following: lack of awareness that screening is recommended in the absence of symptoms, lack of information about the screening guidelines, lack of a physician referral, cost,

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TABLE 2 Overview of Main Educational Messages Provided to FDRs Future intentions to get screening test within recommended time interval Very/somewhat likely

Currently adherent Yes

No

Promote self-efficacy by emphasizing current adherence Reinforce decision to remain adherent Emphasize gains if screening test obtained Tailored barriers counseling Tailored referral for screening

Not very/not at all likely

Acknowledge family history as risk factor Provide information on recommended screening interval Promote self-efficacy by emphasizing current adherence Provide information on efficacy and value of screening Emphasize losses if screening not obtained

Encourage subject to reconsider decision Tailored barriers counseling Tailored referral for screening

fear or anxiety about the test itself (especially for sigmoidoscopy and colonoscopy), fear about what the test might reveal, procrastination, inconvenience, perceived lack of efficacy of the test, and the test being viewed as embarrassing, unpleasant, or “disgusting” (especially FOBT). These results mirror findings from other studies investigating barriers to colorectal screening [37,39,49,50,98–119]. The most frequently cited facilitators to screening were knowledge of cancer screening guidelines and the efficacy of the test, physician referral, peace of mind, the fact that early diagnosis and treatment will reduce morbidity and mortality, convenience (especially FOBT), familial or personal risk (having an FDR with colon cancer), and having insurance coverage for the test. Specific questions will be developed that translate these barriers and facilitators into pros and cons statements in a manner similar to that for the breast project (as illustrated in Table 3). Finally, the intervention interview will conclude with an invitation to provide the FDR with more information on how to obtain the recommended screening tests. As will be indicated below, the specificity of this referral information will differ, depending on whether the subject is an FDR of a breast or colorectal cancer patient.

Acknowledge family history as risk factor Provide information on recommended screening interval Reinforce decision to obtain screening test Provide information on efficacy and value of screening test If ever had test, promote self-efficacy by acknowledging prior behavior; if never had test, promote selfefficacy by acknowledging ease of obtaining test Emphasize gains if screening test obtained Tailored barriers counseling Tailored referral for screening Acknowledge family history as risk factor Provide information on recommended screening interval Provide information on efficacy and value of screening test Emphasize losses if screening not obtained If ever had test, promote self-efficacy by acknowledging prior behavior; if never had test, promote selfefficacy by acknowledging ease of obtaining test Encourage subject to reconsider decision Tailored barriers counseling Tailored referral for screening

At the conclusion of the baseline interview, all subjects (intervention and control) will be mailed a letter thanking them for participating in the interview. In addition, included in the thank-you letter for intervention subjects will be the same educational messages provided during the telephone counseling component of the intervention, including the same tailored referral information that was provided at the conclusion of the interview. For intervention subjects, this mailing will also include additional print material that will specifically target their FDR status and emphasize the recommended cancer screening tests.

RESULTS FROM TWO FEASIBILITY SURVEYS

The successful implementation of both research projects rests upon two fundamental assumptions. First, it is assumed that cancer patients will comply with the request to grant access to their FDRs. Second, it is assumed that FDRs will be receptive to the intervention. The viability of both assumptions was investigated in the two feasibility studies described below.

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TABLE 3 Example of Interactive Barriers Counseling Intervention Pros/cons statement Anxiety/fear about what might be found Question: I would be more likely to get a mammogram if I weren’t so worried about the results. Counseling: If answer is agree or undecided.

Physician did not recommend Question: If my doctor doesn’t recommend a mammogram, I don’t need to have one. Counseling: If answer is agree or undecided. Cost of mammograms Question: Mammograms are too expensive for me. Counseling: If answer is agree or undecided. Fear of radiation Question: The risk from the radiation of several mammograms over a few years is really quite high.

Counseling: If answer is agree or undecided.

Counseling For some women, thinking about having a mammogram reminds them about the possibility that the results might be abnormal—or that they could get breast cancer themselves. And their worry can make it hard for them to get a mammogram. Even if you have an abnormal result and need a biopsy, 8 of 10 times biopsies turn out negative for breast cancer. Most women with a family histroy of breast cancer will never get it themselves, but the important thing is to catch it early when you have the best chance that it can be cured. Taking a positive action like getting a mammogram is one good way to take control of the situation and deal with your worry. If your doctor was seeing you for a specific problem, your doctor may not have included a regular breast exam or advised you to get a mammogram, but most doctors are happy to talk with their patients about preventing disease. If you haven’t had a physical exam in the past year, I would encourage you to make an appointment soon. I would also suggest that you share your family history of breast cancer with your doctor. I can give you a couple of free phone numbers to call in your area that may help you find a low-cost mammogram. Interviewer: Use referral database to locate phone numbers for agencies providing free or low cost mammograms. Experts agree that the benefits of getting mammograms for the early detection of breast cancer far outweigh the risks of radiation from the mammogram. Mammography equipment and techniques have improved so much in the past few years that the dose of radiation is extremely small and not harmful. For example, the amount of radiation in a mammogram is about the same you would get walking outdoors for about 10 min. We have a large nationwide list of mammography facilities that have been approved by the FDA. These facilities must meet high standards in order to be accredited. If you like, we can provide you with the names of accredited facilities near your home.

Survey of Breast and Colorectal Cancer Patients To investigate the willingness of cancer patients to grant access to their FDRs, a survey was conducted of breast and colorectal cancer patients. A secondary goal of this survey was to estimate the average yield of eligible FDRs per patient. This information was needed to finalize the recruitment plan for FDRs. The patient survey was conducted in two phases. During Phase I, patients were approached at participating hospitals and clinics and asked to complete a self-administered questionnaire. Included in this survey was a question asking patients if they would provide the names, addresses, and telephone numbers of their FDRs for the purpose of calling them to encourage cancer screening. During Phase II, these patients were then called to obtain this information. For breast cancer patients, an eligible FDR was defined as a mother, sister, or daughter, 401 years of age. For colorectal cancer patients, an eligible FDR was defined as a mother/father, sister/ brother, son/daughter, 401 years of age. Breast cancer patients were surveyed on-site (selfadministered questionnaires) over a 3-month period at a private breast cancer clinic, a university-based hospital, and a public supported hospital, all of which were

located in the Denver metropolitan area. Colorectal cancer patients were also surveyed on-site over a 3-month period at two hospitals in the Denver metropolitan area (a university-based hospital and a Department of Veterans Affairs Medical Center). Both of the on-site surveys netted a convenience sample of patients who visited participating hospitals and clinics during the accrual period. Of those patients who were approached on-site, response rates exceeded 95%. What is not known is the percentage of breast and colorectal cancer patients who were actually approached on-site by clinic staff. Our original plan was to use this same strategy for accrual of patients into the main study. However, debriefing interviews with clinic staff indicated that requiring onsite contact with patients and asking them to complete a brief self-administered questionnaire were both inefficient and potentially disruptive to clinic routines. As a result, all eligible patients were not approached for survey participation. Based in part on this information, the protocol for approaching patients in the main study was subsequently changed (as described previously) to allow for initial contact by mail rather than by personal contact with clinic staff. Although both of these convenience surveys must be

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interpreted with appropriate caution, the results did suggest the viability of approaching patients to gain access to their FDRs. For example, • Of the 132 eligible breast cancer patients surveyed on-site, 106 (80%) agreed to provide information about their FDRs. Due to resource limitations and time constraints, 95 (90%) of these breast cancer patients were then selected for telephone follow-up. • Of the 95 eligible breast cancer patients selected for follow-up, 76 (80%) were reached by telephone, and of these, 74 (97%) provided the requested information about their FDRs. • Of the 46 eligible colorectal cancer patients surveyed on-site, 44 (96%) agreed to provide information about their FDRs, and of these, 100% were selected for telephone follow-up. • Of the 44 eligible colorectal cancer patients selected for follow-up, 33 (75%) were reached by telephone, and of these, 30 (91%) provided the requested information about their FDRs. • The average yield of eligible FDRs per patient was approximately 2.0 for breast cancer patients, compared to 3.1 for colorectal cancer patients. Colorectal cancer patients were more likely than breast cancer patients to refuse access to particular FDRs (citing a need to protect their privacy), as well as to indicate that specific FDRs had no knowledge of the patient’s diagnosis (thus rendering them ineligible for the cancer screening study). Survey of FDRs of Breast and Colorectal Cancer Patients Using lists of FDRs generated from the previously described survey of breast and colorectal cancer patients, a follow-up telephone survey of eligible FDRs was conducted. The following eligibility criteria were established for this interview (based on information obtained from the patient survey): (1) the FDR was 401 years of age, (2) permission was obtained from the cancer patient (i.e., the index case) to contact the FDR, (3) the FDR was already aware of the cancer diagnosis in the index case, (4) the FDR address and telephone number were available, and (5) the FDR resided in the United States. A total of 148 eligible breast cancer FDRs were initially identified, of which 65 were selected for telephone follow-up. Due to time constraints in completing this survey, these 65 cases represent all eligible FDRs that were identified by patients during the first 8 weeks of the patient survey. Among colon cancer patients a total of 93 eligible FDRs were identified, of which 73 were similarly selected for the telephone survey. All eligible FDRs were then mailed an advance letter informing them of how their name and address were obtained, as well as alerting them to the upcoming telephone call from the interviewer.

The FDR survey was conducted to answer two key questions. First, would the FDRs be receptive to a telephone interview that was facilitated by their relative with cancer. Second, when provided with a description of the proposed telephone counseling intervention, would they endorse or support the intervention. Selected highlights from this survey include the following: • Of the 65 eligible FDRs of breast cancer patients, 58 (89%) were successfully contacted, and none refused to be interviewed. Of the 73 eligible FDRs of colorectal cancer patients, 56 (77%) were successfully contacted, and 2 (3.6%) refused to be interviewed. • When asked if they thought the proposed telephone counseling intervention for FDRs was “a good idea,” 95% of breast cancer FDRs and 91% of colorectal cancer FDRs answered in the affirmative. SELECTED RESEARCH AND DESIGN ISSUES

Access to FDRs via Their Relatives with Cancer A unique feature of the CPRU involves using cancer patients (i.e., the index case) to gain access to their FDRs. Two other approaches for recruiting FDRs were also considered. One approach would be to recruit FDRs directly through the mass media (e.g., radio, print media). However, the disadvantages of this approach include the lack of a denominator to estimate participation rates, the highly self-selected nature of the resulting sample, and the concern that underserved populations would not respond to such a campaign. Another approach would be to access FDRs through primary care physicians. The main problem with this strategy is that physicians are often not aware of the FDR status of their patients. Moreover, conducting a patient survey in collaboration with physicians (to identify eligible FDRs) is fraught with logistical problems and is not likely to be cost-efficient for the yield that might be obtained. There also was a compelling interest to involve NCIfunded clinical cooperative groups in the process of recruiting FDRs. This approach would allow such groups to participate in a unique public health program that would target the healthy, asymptomatic FDRs of their cancer patients. In addition, such groups have an existing patient recruitment infrastructure that could be mobilized to yield a cost-efficient strategy for enrolling FDRs. If this approach proves to be successful, it could also be exported nationwide through the existing network of clinical cooperative groups. Identification of Potential Cancer Families Another consideration involves the identification of families with cancer histories suggestive of hereditary cancer. The identification of such families can be inferred from the pedigrees obtained from the patient

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during the telephone interviews described earlier in Fig. 2. This pedigree includes an enumeration of cancer history for all FDRs of the index case, as well as selected second-degree relatives (SDRs) of the index case (i.e., the FDRs of any affected FDR of the index case). The number of affected relatives of the patient is a potentially important moderating variable (e.g., the intervention may prove to be more effective among FDRs with a pronounced family history of cancer). However, the collection of such data also raises a key question: if a potential cancer family is identified, what should be done with this information? The approach taken in response to this question will involve assessment and referral. A specific algorithm will be used to identify potential cancer families, and a referral will be offered to those patients who are eligible. The algorithm that will be used to make this referral (see Table 4) draws upon the guidelines for genetic testing that were recently published by the American Society of Clinical

TABLE 4 Family History Algorithm for Determining Whether Consultation with Physician or Genetic Counselor Should Be Discussed with Index Casea Breast cancer index case pedigree

Colorectal cancer index case pedigree

At least one FDR (including index case) with Breast and ovarian primary cancers, one of which was diagnosed ,50 years of age, or Breast cancer diagnosed ,30 years of age At least two FDRs (including index case) with Breast cancer diagnosed ,50 years of age, or One FDR with breast cancer diagnosed ,50 years and another FDR with ovarian cancer (any age), or Ovarian cancer diagnosed at any age, or At least three FDRs or SDRs on same side of family (including index case) withb Breast cancer, at least one case diagnosed ,50 years, or Breast and ovarian cancer, any age, or Ovarian cancer, any age At least three FDRs or selected SDRs (including index case) withb Colon, ovarian or uterine cancer, and Cancer cases in at least two generations, and At least one of the colon cancer cases diagnosed ,50 years of age

a Family history of breast or colorectal cancer will be obtained from telephone interviews of the index cases participating in this research. FDR, first-degree relative; SDR, second-degree relative. b One case must be an FDR of the index case; the others could be either FDRs or selected SDRs of the index case (i.e., an FDR of one of the affected FDRs of the index case).

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Oncology [120]. It is important to emphasize that at no time will the patient’s family be labeled as a “cancer family.” Given the potential unreliability of cancer pedigrees obtained from a brief telephone interview, such an inference would be unjustified. Nonetheless, patients who appear to have a strong family history of cancer will be encouraged to consult with their physicians about their family history. In addition, the Hereditary Cancer Institute in Omaha, Nebraska, has agreed to accept toll-free telephone inquiries from our patients. Thus, patients who qualify will also receive this referral from the telephone counselor. Anxiety about Cancer among FDRs Previous research has shown that FDRs of breast cancer patients may suffer from significant levels of anxiety or distress resulting from their relative’s diagnosis of cancer and the implications this diagnosis may have for their own sense of vulnerability to breast cancer. For example, in one study of FDRs of breast cancer patients who participated in a breast cancer surveillance program, approximately 25% reported levels of distress that would suggest the need for clinical intervention [32]. However, this was a self-selected group of FDRs who may have joined the cancer surveillance program because of their elevated levels of distress. In another study of FDRs of breast cancer patients, a significant proportion reported intrusive thoughts related to breast cancer (53%) as well as difficulty sleeping (22%) and performing daily activities (30%) [22]. No comparable studies were found that investigated whether FDRs of colorectal cancer patients are more likely than average-risk populations to report clinically significant levels of cancer-specific anxiety or distress. However, one study found that the FDRs of colorectal cancer patients reported significantly greater anxiety than average-risk individuals, but this increased anxiety was not related to colorectal cancer screening behavior [37]. Although these findings are suggestive of significant cancer-specific anxiety among the FDRs of breast cancer patients, a note of caution must be interjected. As noted recently by Stefanek [121], the presence of such symptoms does not necessarily indicate the need for clinical intervention (i.e., the severity of the symptom should be the key determining factor). Nonetheless, these findings raise an important ethical question: how should the telephone interviewers respond to FDRs who might exhibit significant anxiety or distress during the baseline and/or follow-up interviews? In response to this concern, all telephone interviewers will have the option of referring FDRs (both intervention and control) to the Cancer Information and Counseling Line (CICL) of the AMC Cancer Research Center. The CICL, which is a telephone counseling service that has been in existence since 1981, provides information and psychosocial

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counseling free of charge. Individuals can access the CICL by calling a toll-free 800 number. Current call volume to the CICL averages about 4,000 calls per year. The CICL is staffed by two professional counselors, both of whom have undergone extensive training and have many years of experience responding to cancer-related questions and concerns. When a call to the CICL is placed by a client (including the FDRs in the CPRU), the counselor will first perform a brief assessment of the caller’s psychological, physical, and social status in conjunction with the main reason(s) for calling the CICL. This initial assessment will help frame the issues to be explored during the remainder of the call. Based on the counselor’s assessment, a psychoeducational approach will then be utilized to address chief issues of concern. Problem-focused coping strategies will be explored to name the problem evoking significant distress, brainstorm for solutions to the problem, evaluate the solutions, formulate a plan to implement the solution, and reinforce the client’s ability to move forward. Within this framework, counseling strategies for FDRs will generally include seeking and understanding information, identifying and expressing emotions, enhancing social support, and, if appropriate, developing a plan for identifying and utilizing community resources to help the client cope with the distress. To be eligible for this referral, FDRs must display overt and compelling evidence of anxiety or distress (e.g., inability to focus on the interview, crying). Interviewers will be trained to identify situations under which a referral would be appropriate. The concern here is not underreferrals but overreferrals by sympathetic interviewers. It will be emphasized that a certain level of anxiety or distress about the diagnosis of cancer in a relative is appropriate and normal, as is a certain level of anxiety expressed by FDRs about their perceived vulnerability to cancer. The key issue is whether the distress or anxiety is sufficiently compelling to trigger a clinical referral. This aspect of the intervention will be closely monitored by taping all FDR interviews (with appropriate informed consent). Interviewers will be instructed to flag difficult interviews for detailed review by supervisors, including (but not limited to) those interviews that resulted in a referral to the CICL. Detailed review of these taped interviews will assist in on-going quality control and management of the interviewers and reinforcement of appropriate interviewer technique and judgement regarding referrals to the CICL. In addition to those interviews flagged by the interviewers, another 10% of the interviews will be randomly sampled for detailed review by supervisors. It is recognized that this referral protocol, which will be available to both intervention and control subjects, may attenuate the effects of the intervention (e.g., during the call to the CICL, control subjects may conclude

that they should seek cancer screening as a result of the problem-solving exercise). However, of greater concern was the ethical issue of not responding to subjects in distress (regardless of their randomization status). It was also assumed that only a very small percentage of subjects will satisfy the eligibility criteria for this protocol and take advantage of the CICL referral. Thus, if the effects of the intervention are attenuated by this protocol, such attenuation is likely to be small. As a check on this assumption, the number of such referrals that actually result in a call to the CICL (with personal identifiers deleted) will be tracked over time (i.e., a call record form is completed for each CICL call asking the caller to identify how he/she found out about the CICL). Facilitating Access to Cancer Screening Tests To maximize the impact of the counseling intervention, the CPRU counselor will need to go beyond making simple recommendations to obtain a particular test and provide FDRs with specific tailored advice on how to receive these tests. The concluding module in the telephone counseling protocol is designed to provide this type of referral information to FDRs. In both projects, this module shares the key recommendation to consult with your physician. However, beyond this shared recommendation, the two modules differ quite substantially. For screening mammography, a computerized database exists that catalogues all existing FDA-certified screening mammography facilities in the country. Using this database, one can identify all such facilities for a given zip code, telephone prefix, or community. This database was incorporated into the computer program for the breast cancer telephone counseling protocol. To supplement this program, additional information was needed to assist low-income women in obtaining a screening mammogram, as well as to assist women with insurance in determining whether a screening mammogram was covered by their insurance plan. This supplemental database, which was specifically created for the CPRU, lists the toll-free telephone numbers of the state insurance commission, counseling services for Medicaid/Medicare insurance, Commission on Aging, and the state-specific cancer prevention program(s) in all 50 states. For colorectal cancer screening, a much different situation exists. Some insurance plans do not cover sigmoidoscopy or FOBT screening for asymptomatic individuals. Moreover, there is no comparable database that can be used for making specific referrals for sigmoidoscopy, and even if such a database existed, a referral from a primary care physician is currently the standard of care. Thus, counselors will be trained to problem solve with the FDRs on how to consult with a physician. For low-income patients, this module may start with the

BREAST AND COLORECTAL CANCER SCREENING

basic question of how to identify a physician for colorectal cancer screening. In addition, the same supplemental database described above for the FDRs of breast cancer patients will be available to the FDRs of colorectal cancer patients (i.e., the toll-free telephone numbers of the state insurance commission, counseling services for Medicaid/Medicare insurance, Commission on Aging, and the state-specific cancer prevention program(s) in all 50 states). It is important to note that the information conveyed in this referral module will also appear in the tailored follow-up letter that will be mailed to intervention subjects. Thus, for FDRs of breast cancer patients, they will be mailed referral information tailored to their area, as well as the various toll-free telephone numbers that were shared with the FDRs on the telephone. For the FDRs of colorectal cancer patients, the specific problemsolving action plan developed in collaboration with the telephone counselor will also be summarized in the tailored follow-up letter, along with an attractive “patient activation” fact sheet (formatted as a laminated card) that the FDRs can bring with them to the physician’s office. SUMMARY

With the recent advances that have been made in molecular genetic epidemiology, the FDRs of breast and colorectal cancer patients have emerged as a high priority group for cancer control research. Of special concern is that despite their elevated risk for cancer, these two groups of FDRs are not being screened for cancer at recommended levels. The two randomized trials described herein will test a unique intervention strategy to promote such screening among the FDRs of breast and colorectal cancer patients. Among the innovative features of this program of research are the strategy of gaining access to FDRs via their relatives with cancer and the use of the telephone combined with tailored follow-up print material to promote cancer screening. During the developmental phase of both projects, two key assumptions were investigated in a feasibility survey of patients and their FDRs. The first assumption was that cancer patients will provide access to their FDRs. The second assumption is that FDRs will complete a telephone interview facilitated by their relative with cancer. The viability of both assumptions was supported in the two feasibility surveys. Similar findings regarding the willingness of cancer patients to provide access to their relatives have also been reported by other investigators [22,46,122]. In addition, three other issues arose during the developmental phase of both research projects. The first issue was whether to inform patients if a strong family history of cancer was suspected. The second issue had to do with FDRs who may exhibit significant levels of cancer-specific distress

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during the baseline or follow-up interviews. The third issue involved making specific referrals to FDRs for the recommended cancer screening tests. In all three cases, a well-defined protocol was developed that will be implemented in the main study. Over the next several years, the telephone counseling intervention will be tested nationwide. This study will be conducted in collaboration with hospitals and clinics associated with three major NCI-funded clinical cooperative groups: the Eastern Cooperative Oncology Group, the Southwest Oncology Group, and the North Central Cancer Treatment Group. If the results of this research indicate that the telephone counseling intervention is effective, they could provide an exportable strategy for reaching large numbers of high-risk individuals to promote cancer screening. REFERENCES 1. American Cancer Society. Cancer facts and figures—1998. Atlanta: American Cancer Society, 1998. 2. Miki Y, Swensen J, Shalluck-Eidens D, et al. A strong candidate for the breast and ovarian cancer susceptibility gene BRCA1. Science 1994;266:66–71. 3. Easton DF, Bishop DT, Ford D, et al. Genetic linkage analysis in familial breast and ovarian cancer: results from 214 families. Am J Hum Genet 1993;52:678–701. 4. Easton DF, Ford D, Bishop DT, et al. Breast and ovarian cancer incidence in BRCA1-mutation carriers. Am J Hum Genet 1995; 56:265–71. 5. Wooster R, Bignell G, Lancaster J, et al. Identification of the breast cancer susceptibility gene BRCA2. Nature 1995;378: 789–92. 6. Malone KE, Daling JR, Thompson JD, O’Brien CA, Francisco LV, Ostrander EA. BRCA1 mutations and breast cancer in the general population: analyses in women before age 45 years with first-degree family history. JAMA 1998;279(12):922–9. 7. Newman B, Mu H, Butler LM, Millikan RC, Moorman PG, King MC. Frequency of breast cancer attributable to BRCA1 in a population-based series of American women. JAMA 1998; 279(12):915–21. 8. Couch FJ, DeShano ML, Blackwood MA, Calzone K, et al. BRCA1 mutations in women attending clinics that evaluate the risk of breast cancer. N Engl J Med 1997;336(20):1409–15. 9. Fishel R, Lescoe MK, Rao MRS, et al. The human mutator gene homolog MSH2 and its association with hereditary nonpolyposis colon cancer. Cell 1993;75:1027–38. 10. Lindblom A, Tannergard P, Werelius B, et al. Genetic mapping of a second locus predisposing to hereditary nonpolyposis colorectal cancer. Nat Genet 1993;5:279–82. 11. Peltomaki P, Aaltonen L, Sistonew P, et al. Genetic mapping of a locus predisposing to human colorectal cancer. Science 1993; 260:810–2. 12. Kinzler KW. Genetics of hereditary colon cancer. Proc Am Assoc Cancer Res 1995;36:668–9. 13. Harris JR, Lippman ME, Veronesi U, et al. Breast cancer. N Engl J Med 1992;327:319–28. 14. Vogel VG. Assessing women’s potential risk of developing breast cancer. Oncology 1996;10(10):1451–61. 15. Fuchs CS, Giovannucci EL, Colditz GA, Hunter DJ, Speizer FE, Willet WC. A prospective study of family history and the risk of colorectal cancer. N Eng J Med 1994;331(25):1669–74.

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