A Clinical-Based Intervention Improves Diet in Patients with Head and Neck Cancer at Risk for Second Primary Cancer

A Clinical-Based Intervention Improves Diet in Patients with Head and Neck Cancer at Risk for Second Primary Cancer

RESEARCH Research and Professional Briefs A Clinical-Based Intervention Improves Diet in Patients with Head and Neck Cancer at Risk for Second Primar...

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RESEARCH Research and Professional Briefs

A Clinical-Based Intervention Improves Diet in Patients with Head and Neck Cancer at Risk for Second Primary Cancer GRACE A. FALCIGLIA, EdD, RD; KIMBERLY M. WHITTLE, RD; LINDA S. LEVIN, PhD; DAVID L. STEWARD, MD

ABSTRACT A diet rich in fruits and vegetables is associated with a reduced risk of head and neck cancer. This study was designed to assess the efficacy of an intervention to increase fruit and vegetable consumption and improve overall diet quality in patients with early stage head and neck cancer at risk for second primary cancer. The study was a crossover-controlled design with each patient being his or her own control. Patients received usual care during the control period followed by a clinical-based intervention grounded in the Social Learning Theory for 3 months. Measurements were taken at baseline, 6 months, and 12 months. The intervention consisted of a face-to-face counseling session, a phone call, and three mailings. Findings from this study indicate that these patients increased their intake of fruits (number of servings and variety), vegetables (number of servings), and improved overall diet quality while exposed to the intervention as compared with usual care. J Am Diet Assoc. 2005;105:1609-1612.

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ral and pharyngeal cancer is the 10th most common cancer among US men and the 14th most common among US women (1). The 5-year survival rate is only 53% (1). Risk factors include tobacco and alcohol use along with poor dietary habits (1-3). Individuals who get a cancer of the oral cavity have an increased risk of developing a second primary cancer of the oral cavity (1,3). To reduce this risk, these patients are strongly encouraged to stop using tobacco and alcohol, but are rarely encouraged to modify their diet.

G. A. Falciglia is a professor of nutrition and, at the time of the study, K. M. Whittle was a graduate nutrition student, Department of Nutritional Sciences, L. S. Levin is an associate professor, Department of Environmental Health, and D. L. Stewart is an associate professor, Department of Otolaryngology, University of Cincinnati, Cincinnati, OH. Address correspondence to: Grace A. Falciglia, EdD, RD, Professor of Nutrition, Department of Nutritional Sciences, University of Cincinnati, 3202 Eden Ave, Cincinnati, OH 45267-0394. E-mail: [email protected] Copyright © 2005 by the American Dietetic Association. 0002-8223/05/10510-0011$30.00/0 doi: 10.1016/j.jada.2005.07.009

© 2005 by the American Dietetic Association

Although there is a lack of research investigating the specific levels and types of fruits and vegetables needed to prevent second primary tumors, it has been demonstrated that a diet high in antioxidant nutrients, specifically a diet rich in fruits and vegetables, protects against the risk of primary head and neck cancer (4-6). Although the evidence about the efficacy of interventions to modify fruit and vegetable intake in the general population seems promising (7), it is uncertain whether such interventions are feasible in patients with head and neck cancer, who tend to be older individuals in fragile health. Therefore, this study was designed to investigate the effectiveness and feasibility of a 3-month clinical-based intervention to increase fruit and vegetable consumption within the context of a healthful diet in patients with head and neck cancer. METHODS Participants Patients with head and neck cancer were recruited from the otolaryngology– head and neck surgery outpatient practice at the Barrett Cancer Center of the University Hospital, Cincinnati, OH. Physicians recruited the patients during routine cancer surveillance office visits. Patients were included in the study if they had a diagnosis of stage I or II squamous cell carcinoma of the oral cavity, if they were within 2 months to 5 years from completion of therapy for their cancer, if they were free of cancer, if they obtained all nutritional and caloric intake by mouth, if they were at least 21 years of age, and if they had a Karnofsky performance status greater than or equal to 80. The University of Cincinnati Institutional Review Board approved the study. All participants gave written informed consent and Health Insurance Portability and Accountability Act authorization. Procedures All eligible patients who agreed to participate in the study had a complete history and physical exam. Participants were subsequently informed that a registered dietitian would call them to explain the study protocol and administer a short, formative data questionnaire to learn about their food habits. This assessment was used in the development of the intervention curriculum. The design of the trial was a crossover-controlled design with each patient being his or her own control. Mea-

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surements were taken three times: baseline (time 1), 6 months (time 2), and 12 months (time 3). The control period extended from time 1 to time 2 and the intervention period extended from time 2 to time 3, with 3 months of curriculum delivery followed by 3 months of no contact. Therefore, the measurement at time 2 served as an evaluation mark for both periods (post-control and pre-intervention). Data were collected using three random, unscheduled, interviewer-administered 24-hour dietary recalls over a 15-day period. The interviews were conducted by telephone with trained registered dietitians at the Dietary Data Center at the University of Cincinnati Medical Center. Participants were given serving-size booklets in advance so they could refer to specific pictures when reporting amounts of food consumed. Also, a validated fruit and vegetable checklist was used to find the number of different fruits and vegetables consumed during the same 15day period used for the recalls. Research has shown that people need that length of time to display their entire food repertoire (8). During the control period (the first 6 months of the study), patients received a standard diet and cancer brochure (usual care) developed by a leading health organization in cancer prevention. This brochure was mailed immediately after baseline data collection was completed. After this mailing was sent, patients were not contacted again until the 6-month follow-up evaluation phone call. Immediately after the phone call, patients began the intervention period. The general eating pattern recommended by this study was based on the Healthy People 2010 report (1) and the 5th edition of the Dietary Guidelines for Americans (9), released in 2000. This intervention specifically addressed increasing consumption of a variety of deep-colored fruits and vegetables while preserving the quality of the diet as a whole. Emphasizing variety of fruits and vegetables served as a mechanism for increasing the total number of servings of fruits and vegetables as well as variety of antioxidants and phytochemicals consumed. The Social Learning Theory, commonly used in studies of health behavior change, was chosen as the basis of the intervention. Behavior is explained in Social Learning Theory in terms of a reciprocal model in which behavior, personal factors, and environmental influences all interact (10). The Figure lists the major concepts in Social Learning Theory and examples of their application in this intervention. The intervention lasted 3 months and included one individualized counseling session, one telephone contact, and three mailings. John and colleagues (11) have shown that this delivery format is cost-effective and allows for easy dissemination of information to patients. The registered dietitian responsible for conducting the counseling session and phone interviews was trained in food behavior modification and motivational interviewing techniques by a behavioral health educator. During the 45-minute face-to-face counseling session, the dietitian encouraged patients to eat a healthful diet including at least two servings of fruit and three servings of vegetables daily. Patients who were already eating five servings of fruits and vegetables per day were asked to aim for four servings of fruit and five servings of vegetables daily. The importance of variety, particularly variety

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Environment

Spouse involvement in the program’s activities.

Expectancies

Patients learned that eating a healthful diet rich in fruits and vegetables might decrease the risk of developing a second cancer.

Expectations

Setting clear goals for the patient: eat a healthful diet, eat at least two servings of fruits and three servings of vegetables a day, and choose a wide variety of fruits and vegetables.

Behavioral capability

Allowing patients the opportunity to gain confidence in performing each target behavior by learning about the behavior itself (knowledge) and how to perform the behavior (skill).

Self-efficacy

Allowing patients to practice a single task (ie, preparing a shopping list including fruits and vegetables). Approaching behavior change in small steps. Dealing with barriers to eating fruits and vegetables.

Self-control

Daily monitoring of fruit and vegetable intake. Weekly goal established by participant. Weekly reward established by participant for meeting goal.

Reinforcements

Dietitian reviewed self-monitoring records and provided feedback.

Figure. Major concepts in Social Learning Theory and examples of their application in an intervention to increase fruit and vegetable consumption and improve diet quality in cancer patients.

of richly colored fruits and vegetables, was also discussed. In addition, patients received instructions about specific strategies to achieve goals, how to overcome barriers, and self-monitoring techniques. Finally, the dietitian discussed upcoming telephone contacts and mailings. Two weeks after the counseling session, the dietitian telephoned the patient and used a detailed script to reinforce the message and discuss any problems. The telephone call lasted approximately 20 minutes. At 1, 2, and 3 months after the counseling session, a letter was sent to the participants reinforcing the 5- to 9-a-day message, together with a brochure including seasonal recipes. After the last mailing was sent, patients were not contacted again until the 6-month follow-up evaluation telephone call (3 months after cessation of the intervention). Outcome measures were fruit and vegetable consumption (number of servings and variety) and quality of the diet as a whole, which was assessed using the US Department of Agriculture Healthy Eating Index (HEI) scoring

Table. Means and standard errors (SE) of dietary outcomes at times 1, 2, and 3 and mean differences (SE) for time 2-1 and time 3-2 Time 1 (nⴝ14) Intake Fruits (servings) Vegetables (servings) Fruits and vegetables (servings) Fruit (variety) Vegetables (variety) Fruits and vegetables (variety) HEId Fruit score Vegetable score Total HEI score

Time 2 (nⴝ18)

Time 3 (nⴝ16)

4™™™™™™™™™™ mean⫾SE ™™™™™™™™™3 1.3⫾0.3 1.5⫾0.3 2.7⫾0.3 1.8⫾0.3 2.1⫾0.3 3.4⫾0.3 3.1⫾0.5 3.6⫾0.4 6.0⫾0.5 6.3⫾0.9 8.2⫾0.8 11.6⫾0.8 12.9⫾1.3 15.8⫾1.1 15.2⫾1.2 19.2⫾1.8 24.0⫾1.6 26.8⫾1.7 5.7⫾0.9 5.7⫾0.7 70.7⫾3.2

5.6⫾0.8 6.8⫾0.6 72.0⫾2.9

8.4⫾0.8 9.1⫾0.7 79.6⫾3.0

Control time 2-1 mean⫾SE 0.2⫾0.4 0.3⫾0.4 0.5⫾0.7 1.9⫾1.2 2.9⫾1.7 4.8⫾2.4 ⫺0.1⫾1.2 1.1⫾0.9 1.3⫾4.3

P valuea

Intervention time 3-2

P valueb

.67 .40 .42 .11 .10 .05

mean⫾SE 1.2⫾0.4 1.2⫾0.4 2.4⫾0.6 3.3⫾1.1 0.6⫾1.6 2.7⫾2.3

.01c .004 .0008 .007 .70 .25

.95 .26 .76

2.8⫾1.1 2.3⫾0.9 7.7⫾4.2

.02 .01 .07

a

P value for change from time 1 to time 2 (2-1). P value for change from time 2 to time 3 (3-2). Bolded P values denote significance at ⱕ.05. d HEI⫽Healthy Eating Index. b c

system. Data from the three 24-hour dietary recalls were used to calculate the number of servings of fruits and vegetables consumed daily as well as HEI scores. HEI scores range from 0 to 100, with 10 equally weighted components, each with a score ranging from 0 to 10. For example, a score of 10 for the fruit group component indicates that the patient’s diet met the recommendation for the fruit group. Variety of fruits and vegetables in this study was defined as the cumulative number of different fruits and vegetables a person consumed over 15 days. The fruit and vegetable checklist was used to calculate variety. Statistical Analysis Dietary outcomes were analyzed to estimate mean and standard error values at times 1, 2, and 3. A two-tailed Student t test was used to statistically determine if the mean change from time 1 to time 2 was equal to the change from time 2 to time 3. This analysis was initially adjusted for sex and then separately adjusted for previous smoking status. Data analysis was done with Statistical Analysis Systems (SAS) software (version 8.02, 1999, SAS Institute Inc, Cary, NC). RESULTS AND DISCUSSION Of the 24 eligible patients contacted, 18 responded positively to the initial invitation and were considered study participants. The mean age of this population of patients was 58 years, ranging from 33 to 79 years. The sex distribution was approximately 50% men and 50% women. The racial makeup was 100% white (this practice group had few minority patients). None of the participants were current smokers. There were no significant differences between the patients who agreed to participate in the study and those who did not with respect to age, sex, racial distribution, and smoking habits. The Table shows the group means (⫾standard error) for fruit and vegetable servings and variety and overall HEI score at times 1, 2, and 3, along with the mean

change for time 2 to time 1 and time 3 to time 2. Mean values increased significantly in the intervention period for fruit servings (1.2⫾0.4), vegetable servings (1.2⫾0.4), fruit and vegetable servings (2.4⫾0.6), and for fruit variety (3.3⫾1.1). This increase in daily fruit and vegetable servings is more than the increase of 1.4⫾1.7 found by John and colleagues in a healthy population (11). The HEI analysis showed a significant increase in the fruit (2.8⫾1.1) and vegetable (2.3⫾0.9) scores, which contributed to an increase, approaching significance, in the total HEI score. During the control period, no significant changes were found, with exception of the combined fruit and vegetable variety score, which increased by 4.8⫾2.4 points. The outcome measures were not significantly affected by sex or previous smoking status. The difference in change between the times (3-2 and 2-1) was not significant for any dietary outcome, probably due to the small sample size of the study. Another limitation of the study was the lack of biomarkers to validate self-reported intake. Further studies should consider including objective measurements of fruit and vegetable intake, such as plasma carotenoids and vitamin C, in at least a subsample of subjects. CONCLUSIONS Patients with early-stage head and neck cancer are at significant risk for development of second primary cancers. They tend to be poorly nourished and their fruit and vegetable consumption is less than that of the general population. Even though this patient population tends to be older and in fragile health, our study shows that a clinical-based dietary intervention is feasible and effective in increasing fruit and vegetable consumption, thereby improving overall diet quality in patients with head and neck cancer. References 1. US Department of Health and Human Services. Healthy People 2010: Understanding and Improving

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Health. 2nd ed. Washington, DC: US Government Printing Office; Nov 2000. Block G, Patterson B, Subar A. Fruit, vegetables, and cancer prevention: A review of the epidemiological evidence. Nutr Cancer. 1992;18:1-29. Position of the American Dietetic Association: Oral health and nutrition. J Am Diet Assoc. 2003;103:615625. Diet and nutrition in the etiology of oral cancer. Am J Clin Nutr. 1995;61(suppl):S437-S445. Tavani A, Gallus S, La Vecchia C, Talamini R, Barbone F, Herrero R, Franceschi S. Diet and risk of oral and pharyngeal cancer. An Italian case-control study. Eur J Cancer Prev. 2001;10:191-195. Levi F, Pasche C, La Vecchia C, Lucchini F, Franceschi S, Monnier P. Food groups and risk of oral and pharyngeal cancer. Int J Cancer. 1998;77:705-709. US Department of Health and Human Services. The Efficacy of Interventions to Modify Dietary Behavior

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