- Email: [email protected]
The use of semistructured interviews to assess quality of life impacts for patients with uveal melanoma
The use of semistructured interviews to assess quality of life impacts for patients with uveal melanoma Brianna C. Kopp, MPH,* R. Trafford Crump, PhD,† Ezekiel Weis, MD, MPH†,‡ ABSTRACT ● Objective: There are limited studies on uveal melanoma and patient quality of life. However, the burden of implementing a patientreported outcome measure to collect this information in a clinical setting is unknown. The objectives of this study were (i) to understand the issues of quality of life that are most important to patients undergoing treatment for uveal melanoma, (ii) to explore patient views on the European Organization for Research and Treatment of Cancer's (EORTC) ophthalmic oncology quality of life questionnaire (QLQ-OPT30), and (iii) to assess patient willingness to complete questionnaires measuring quality of life on an ongoing basis. Design: This was a qualitative study. Participants: The study included 10 patients treated for uveal melanoma with brachytherapy at the Alberta Ocular Brachytherapy Program, with a mean follow-up period of 16.3 months (range 5–33 months) after diagnosis. Methods: The participants completed a qualitative interview over the phone with a trained interviewer between November 2014 and January 2015. Participants completed the QLQ-OPT30 according to their current symptoms and then elaborated on their responses. The participants then completed a semistructured interview to provide more information about the symptoms or issues that had the most impact on quality of life. Results: The participants expressed positive feelings about the QLQ-OPT30; however, the participants’ responses revealed that several themes, including mental health, impact of diagnosis and treatment on family, travel and financial burdens of treatment, and impact on work and home life, were missing in the questionnaire. Conclusions: The QLQ-OPT30 performed well, but some missing constructs were identified. Furthermore, participants took 23 minutes to complete the QLQ-OPT30 with a trained interviewer, and this could present logistical challenges when using it at the point of care.
Uveal melanoma is the most common primary intraocular cancer in adults, but it is rare compared with other types of cancer, with an incidence rate of only 5.1 cases per million people.1 Until recently, enucleation, or removal of the eye, was the most common treatment. Advances in radiation and surgical techniques have given rise to eye-sparing options, and brachytherapy has emerged as one of the most common treatments for tumours worldwide. With brachytherapy, a radioactive plaque is surgically placed behind the patient’s eye, remains there for several days (5–7 days in the case of E.W.’s practice), and then is removed. Brachytherapy has several advantages over enucleation. Preserving the eye is typically aesthetically superior to enucleation and is less emotionally distressing to patients, and useful vision from that eye may be retained in the majority of patients, with no decrease in overall survival.2 Brachytherapy is associated with more medical visits and interventions preoperatively and postoperatively compared with enucleation. Patients may experience changes in their visual acuity, pain, and distress because of risk of recurrence,3 all of which can have a negative effect on patients’ quality of life. By measuring and tracking these
experiences, clinicians can be more informed about patient care, which, ultimately, may improve the patientcentredness with which this care is delivered. Patient-reported outcomes (PROs), such as quality of life, are increasingly used to measure patients’ well-being and the symptoms they are experiencing.4 PROs are standardized questionnaires that ask patients about symptom severity, physical function, and ability to carry out daily activities.5 There are many methods of collecting PROs; collection of data during regularly scheduled visits is commonly referred to as a “point-of-care” evaluation.6 There are unique considerations when selecting a PRO questionnaire for use at the point of care rather than in a clinical trial. Questionnaires that are too long have been shown to have lower completion rates and affect the validity of responses.6 It should be easy to score the questionnaires quickly so that the results inform communication with patients without affecting clinical workflow.7 Specific to oncologic care, PROs offer several advantages when collected at the point of care, including improved communication between physician and patient; improved health-related quality of life and emotional functioning;7 and improved symptom management,8 such
& 2016 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jcjo.2016.10.005 ISSN 0008-4182/16 CAN J OPHTHALMOL — VOL. ], NO. ], ] 2016
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Quality of life with uveal melanoma—Kopp et al. as referrals to psychosocial care9,10 or pain management.11 Patients with cancer may benefit from the use of PROs because of their considerable levels of physical and psychosocial distress.12,13 The most relevant PRO questionnaire available for patients diagnosed with uveal melanoma is the 30-item QLQ-OPT30, developed by the European Organisation for Research and Treatment of Cancer (EORTC) Ophthalmic Oncology Task Force.14 As with all EORTC tumourspecific questionnaires, the QLQ-OPT30 is designed to be used with another 30-item questionnaire, referred to as the QLQ-C30, which is generic to all cancer diagnoses.15 There are, however, some limitations to using the QLQOPT30 at the point of care. First, when combined with the QLQ-C30, there are 60 items in total, and thus the questionnaire may be too long to administer in a clinical setting. Second, feedback from patients in a Polish validation study raised questions about the appropriateness of the QLQ-OPT30 when used with some patients.16 Third, patients with uveal melanoma rarely report symptoms such as constipation, diarrhea, appetite loss, nausea, or vomiting,17 and questions on these symptoms constitute the bulk of items in the QLQ-C30. This may reduce the sensitivity of both questionnaires for patients with uveal melanoma, making it difficult to discriminate between patients who report no or few problems with these symptoms.6 As a result of these concerns, this exploratory study set out to address four aims: (i) to understand the issues of quality of life that are most important to patients undergoing brachytherapy for uveal melanoma, (ii) to explore patient views on the QLQ-OPT30 questionnaire, (iii) to assess the length of time to complete the QLQ-OPT30, and (iv) to assess patients’ willingness to complete the questionnaires measuring quality of life on an ongoing basis. We chose to use only the QLQ-OPT30, rather than the QLQ-C30 plus the QLQ-OPT30, for two reasons: (i) the finding by the Polish validation study that many of the items in the QLQ-C30 did not apply; and (ii) guidance from the International Society for Quality of Life Research that recommended questionnaires intended for use at the point of care be brief.18
METHODS Study population and setting
Participants were recruited from the Alberta Ocular Brachytherapy Program at the Royal Alexandra Hospital in Edmonton, Alberta, and the Rockyview Hospital in Calgary, Alberta. All participants had received treatment for uveal melanoma at clinics located in Edmonton or Calgary. Ethical approval for the study was provided by the Health Research Ethics Board of Alberta. Sampling
A series of consecutive patients, over 18 years of age, whose first language was English and who had been
2
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treated for uveal melanoma in the past 3 years, were invited to enroll in the study. The list included patients of both genders and of different ages, who were living at different distances from a clinic location and had varying levels of social and financial support. Interview procedure
A trained interviewer (B.K.) made 3 attempts to reach each patient by phone to set up an interview. Those who agreed to participate underwent a 2-step interview that was scheduled at a time convenient for the participant. Participants were asked to complete the QLQ-OPT30 (following developer instructions and using the 1-week recall time frame) and provide answers based on their current symptoms. Questions in the QLQ-OPT30 were grouped by category: ocular irritation (items 31–36); vision impairment (items 37–39); headaches (item 40); worry about disease recurrence (items 41–43); issues related to appearance (items 44–45); functional problems caused by vision impairment (items 46–51); problems with activities and reading (items 51–52); functional problems in the treated eye (items 53–58); and difficulty driving (items 59– 60). Response options ranged from “not at all” (score of 1) to “very much” (score of 4). A total score was generated by summing the responses to all the questions, with a minimum score of 30 and maximum score of 120; higher scores indicated greater symptom severity. Follow-up questions were asked after completion of each category. For example, after the 6 questions on ocular irritation, the interviewer asked the patient, “Did you experience other types of irritation in your treated eye?” to determine if the questions on ocular irritation encompassed the experiences of the patient. The interviewer then asked the patient, “How much would you say the irritation in your treated eye impacts your quality of life?” These questions, or variants based on the content and previous answers of the patient, were asked for each section. The second step of the interview process involved a semistructured interview, which the interviewer completed immediately after administration of the QLQ-OPT30. In the semistructured interview, the interviewer used a predefined list, or guide, of questions. The guide was followed, but the interviewer asked follow-up questions of the respondent to gather more information or to follow the natural trajectory of the conversation. All comments were recorded by the interviewer in detailed notes. Analysis
Because of the exploratory nature of this study, an inductive analysis approach was undertaken. A thematic content analysis of the patient responses from all components of the interview was conducted. This type of analysis is sufficient for projects that are exploratory in nature or when the goal is to identify key issues of concern for a patient population.19 The interview transcripts were
Quality of life with uveal melanoma—Kopp et al. reviewed, and the participants’ responses were entered into a spreadsheet. Once the data from all of the participants were entered, the responses were reviewed a second time, and themes were identified.
RESULTS Participants
Thirteen participants were contacted by phone and asked to participate, and 10 completed interviews. All who participated in the interviews had received brachytherapy for their uveal melanoma. The mean age of the participants was 52.2 years (range 30–81 years; standard deviation (SD) ¼ 19.6). Three participants were retired, 6 were currently working, and 1 stayed at home as a primary caregiver for children. The mean travel time from home to surgery location (Edmonton) was 280.1 minutes (range 156–573 minutes; SD ¼ 143.1), and the mean travel time from home to nearest clinic location (Calgary or Edmonton) was 153.8 minutes (range 6–476 minutes; SD ¼ 178.6). All participants had been diagnosed with uveal melanoma within the last 3 years (mean 16.3 months; range 5–33 months). All participants were currently receiving ongoing follow-up. Aim 1: Patient perspectives of most important quality-of-life issues
On the basis of the interviews, 5 main themes were identified (see Table 1 for a detailed summary). Three of
the themes were concerned with the more social aspects of well-being: (i) impact on work life, (ii) impact on home life, and (iii) changes to usual daily activities. Themes 1 and 2 were not covered in the QLQ-OPT30. Several participants mentioned a need to make adjustments in their work duties or their workplace arrangements (lighting needs, increasing frequency of breaks during the work day), and 1 participant mentioned a need to change careers as a result of treatment. Participants also mentioned concerns about the impact of treatment on their home life, both in their ability to carry out their normal chores or responsibilities at home, the stress of the diagnosis on their family, and concerns over the financial impacts of time taken off from work or spent on travel for treatments. The third of these social aspect themes, changes to usual daily activities, is present in the existing QLQ-OPT30, but the participants identified other activities that they had difficulty with as a result of their treatment for uveal melanoma, including showering, watching television or movies, and a general fear of being alone that lead to loss in independence. Two other themes were concerned with the healthrelated aspects of well-being: (i) vision impairment and irritation, and (ii) mental health,. Although the QLQOPT30 has 9 items related to vision impairment and irritation, the participants mentioned additional types of impairment and irritation that they had experienced, such as pressure on the eye, drooping of the eyelid, pain, discomfort, and aching in the eye. The participants also
Table 1—Themes that emerged from 10 semistructured interviews about the impacts of uveal melanoma diagnosis and treatment on patient quality of life Theme
Issues
Impact on work life
Not covered in the QLQOPT30
Impact on home life
Not covered in the QLQOPT30
Changes to usual daily activities
Additional issues could be addressed
Vision impairment and irritation
Additional issues could be addressed
Mental health
Additional issues could be addressed
Comments Need to change careers because of change in vision Adjustment of work activities because of changes in vision, including modifications to work environment Taking time off work for treatment and recovery Burden of number of medical appointments Financial burden of treatment Impact of travel for treatment Burden on others to assist with care during treatment (caregiving, driving to medical appointments) Impact of diagnosis on family Burden of number of medical appointments Not being able to perform same chores or responsibilities at home Showering (hard to balance oneself) Watching television or movies Anything that moves eyes from side to side Fear of being alone Loss of independence Pressure on eye, such as a feeling of a suction cup on it Weakened muscles in eye, resulting in drooping Straining of the eye Blurriness Fatigue in eye A feeling of looking through mesh or nylon Sensation of things moving away Pain and discomfort Aching in the eye Mental health of patient Emotional impact of diagnosis How diagnosis is shared with patient Sensitivity of existing questions on recurrence for patients who have already experienced recurrence or metastases Stress resulting from waiting to see specialist and waiting for surgery
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Quality of life with uveal melanoma—Kopp et al. mentioned several aspects of mental health that are not addressed in the QLQ-OPT30, including the emotional impacts of the diagnosis and stress caused by waiting to see a specialist after the initial referral. Aim 2: Performance and patient views of the QLQ-OPT30
On average, it took 22.6 minutes to complete the QLQ-OPT30 and the follow-up questions, and it took 22.4 minutes to complete the semistructured interview. The mean score on the QLQ-OPT30 was 41.9 out of a maximum score of 120 (range 30–54; SD ¼ 8.0). In general, the participants had positive feelings about the survey, indicating that it was “good” and “seemed to cover all the items.” Some participants expressed more negative views about the survey. One stated that the questionnaire was “quite repetitive, especially when a lot of the answers are very little or nothing.” Another participant stated, “They didn’t ask anything about the diagnosis, just the treatment. I find the diagnosis is the hardest hit.” Participants had mixed feelings about the recall time frame of 1 week that is used in the QLQ-OPT30. Some felt that the recall period of 1 week was fine because most of their symptoms were experienced in the first few weeks after surgery. Others felt that the recall period should be longer because their symptoms varied from week to week. Aim 3: Patient feedback on the concept of a PRO questionnaire
All of the participants reported that they would be willing to complete a questionnaire, such as the QLQOPT30, on an ongoing basis. Four participants said that they did not think completing the surveys would improve communication with their doctor because they already had good communication with their doctor, whereas 6 participants felt that completing the survey would be helpful in improving communication. Participants also expressed a desire to have a mechanism that would allow them to express the positives of their treatment, as well as their gratitude for their treatment. This type of feedback would likely not be best expressed in a patient-reported outcome questionnaire, but this does suggest that patients may desire to have a means by which they can share broader experiences and satisfaction.
DISCUSSION This study identified several themes related to quality of life that are important to patients undergoing brachytherapy treatment for uveal melanoma. Notable additions include questions on mental health; impact of diagnosis and treatment on family; burden of treatment on patient and caregivers (including travel and financial commitments); and impact on work and home life. Some of these themes are included in the 30-item generic EORTC
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questionnaire (QLQ-C30). Yet, we do not feel that the administration of a 60-item questionnaire (the sum of the QLQ-OPT30 and the QLQ-C30) at the point of care is practical for the aforementioned reasons. It was also suggested that the time frame of the past 1 week may not be the most appropriate measure, particularly for mental or emotional health and worry about recurrence, which can vary greatly throughout a month. The ideal recall period should be thoroughly explored in future studies. These findings provide some insight into how a PRO could be implemented at the point of care. First, there was a general willingness among the study participants to complete a questionnaire on an ongoing basis, over the course of their care. Second, consistent with scoping reviews of the use of PROs in clinical practice,12 several patients felt completing a questionnaire would improve communication with their physicians. Nine out of 10 participants reported minimal to moderate impacts on quality of life in the various categories of the QLQ-OPT30. One participant mentioned a much higher impact on quality of life in the different categories and especially mentioned that issues such as ocular irritation and limitation of activities could be heightened when they were also feeling frustrated, stressed, or depressed about their diagnosis. All of the participants were in the follow-up stage of their treatment and had healed from acute surgical changes, so the answers to some of the questions could have been different if this questionnaire had been administered closer to the surgery.
Limitations
All of the participants had received brachytherapy for uveal melanoma through 1 clinical program in Alberta, Canada, so the findings may not be representative of all patients undergoing treatment for uveal melanoma. Although certain aspects, such as troubling symptoms, may be more universal among patients, other considerations, such as travel distance for treatment, may not be. It is important to expand the research to a diverse set of patients receiving care in other countries and under different health care systems. The sample did not include anyone who had undergone enucleation or anyone with more limited social support, and only 1 participant had lower financial means. Therefore, the 5 quality-of-life themes identified may not be the most important aspects for all patients undergoing treatment for uveal melanoma at all time points after their treatment. The work reported here supports the need for additional focus groups with a broader range of participants who are undergoing additional treatment types in more than 1 clinical program. Of particular importance is identifying the impacts on quality of life for those patients who report few or no impacts on quality of life and
Quality of life with uveal melanoma—Kopp et al. minimal symptoms as a result of their treatment; this will be key to creating a more sensitive questionnaire.
CONCLUSIONS The results from this pilot study suggest that further work is required to develop a PRO measure for use in patients with uveal melanoma at the point of care. An attempt should be made to gather data from semistructured interview questions at multiple treatment centres to improve generalizability. REFERENCES 1. Singh AD, Turell ME, Topham AK. Uveal melanoma: trends in incidence, treatment, and survival. Ophthalmology. 2011;118:1881-5. 2. Diener-West M, Earle JD, Fine SL, et al. The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma, III: initial mortality findings. COMS Report No. 18. Arch Ophthalmol. 2001;119:969-82. 3. Melia M, Moy CS, Reynolds SM, et al. Development and validation of disease-specific measures for choroidal melanoma: COMS-QOLS report No. 2. Arch Ophthalmol. 2003;121:1010-20. 4. McDowell I. Measuring Health. 3rd ed New York, NY: Oxford University Press; 2006 . 5. Department of Health. Guidance on the Routine Collection of Patient Reported Outcome Measures (PROMs). Ottawa, ON: Department of Health; 2009: 1-28. 6. Fayers P, Machin D. Quality of Life. 2nd ed New York: John Wiley & Sons; 2007 . 7. Bilimoria KY, Cella D, Butt Z. Current challenges in using patientreported outcomes for surgical care and performance measurement. JAMA Surg. 2014;149:505-6. 8. Snyder CF, Aaronson NK, Choucair AK, et al. Implementing patient-reported outcomes assessment in clinical practice: a review of the options and considerations. Qual Life Res. 2012;21:1305-14. 9. Nicklasson M, Elfström ML, Olofson J, Bergman B. The impact of individual quality of life assessment on psychosocial attention in patients with chest malignancies: a randomized study. Support Care Cancer. 2013;21:87-95. 10. Lynch J, Goodhart F, Saunders Y, O’Connor SJ. Screening for psychological distress in patients with lung cancer: results of a clinical audit evaluating the use of the patient Distress Thermometer. Support Care Cancer. 2010;19:193-202. 11. Luckett T, Butow PN, King MT. Improving patient outcomes through the routine use of patient-reported data in cancer clinics: future directions. Psychooncology. 2009;18:1129-38. 12. Howell D, Molloy S, Wilkinson K, et al. Patient-reported outcomes in routine cancer clinical practice: a scoping review of use, impact on health outcomes, and implementation factors. Ann Oncol 2015:1-13. 13. Stein KD, Syrjala KL, Andrykowski MA. Physical and psychological long-term and late effects of cancer. Cancer. 2008;112:2577-92.
14. Brandberg Y, Damato B, Kivelä T, Kock E, Seregard S. The EORTC ophthalmic oncology quality of life questionnaire module (EORTC QLQ-OPT30). Development and pre-testing (Phase I-III). Eye (Lond). 2004;18:283-9. 15. Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85:365-76. 16. Chmielowska K, Tomaszewski KA, Pogrzebielski A, Brandberg Y, Romanowska-Dixon B. Translation and validation of the Polish version of the EORTC QLQ-OPT30 module for the assessment of health-related quality of life in patients with uveal melanoma. Eur J Cancer Care (Engl). 2013;22:88-96. 17. Chabert S, Velikay-parel M, Zehetmayer M. Influence of uveal melanoma therapy on patients’ quality of life: a psychological study. 2004;82:25-31. 18. Reeve BB, Wyrwich KW, Wu AW, et al. ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research. Qual Life Res. 2013;22:1889-905. 19. Green J, Thorogood N. Qualitative Methods for Health Research. 3rd ed. London, UK: Sage Publications Ltd.; 2013.
Footnotes and Disclosure: The authors have no proprietary or commercial interest in any materials discussed in this article. This work was supported by funding from the 2014 Alberta Cancer Foundation Transformative Program and the Canadian National Institute of the Blind. From the nResearch and Evaluation, algoþmed, Calgary, Alb; †Department of Surgery, University of Calgary, Calgary, Alb; ‡Department of Ophthalmology, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alb. Previously presented in poster format at the biannual meeting of the International Society of Ocular Oncology, June 16–19, 2015, in Paris, France, and at the Patient Oriented Summer Research Institute, May 3–4, 2016, in Calgary, Alberta, Canada. Originally received Nov. 24, 2015. Final revision Jul. 2, 2016. Accepted Oct. 31, 2016. Correspondence to Brianna C. Kopp, MPH, algoþmed, 100G-2204 2nd Street SW, Calgary, AB, T2S 3C2, Canada; [email protected]
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Uveal melanoma is the most common primary intraocular cancer in adults, but it is rare compared with other types of cancer, with an incidence rate of only 5.1 cases per million people.1 Until recently, enucleation, or removal of the eye, was the most common treatment. Advances in radiation and surgical techniques have given rise to eye-sparing options, and brachytherapy has emerged as one of the most common treatments for tumours worldwide. With brachytherapy, a radioactive plaque is surgically placed behind the patient’s eye, remains there for several days (5–7 days in the case of E.W.’s practice), and then is removed. Brachytherapy has several advantages over enucleation. Preserving the eye is typically aesthetically superior to enucleation and is less emotionally distressing to patients, and useful vision from that eye may be retained in the majority of patients, with no decrease in overall survival.2 Brachytherapy is associated with more medical visits and interventions preoperatively and postoperatively compared with enucleation. Patients may experience changes in their visual acuity, pain, and distress because of risk of recurrence,3 all of which can have a negative effect on patients’ quality of life. By measuring and tracking these
experiences, clinicians can be more informed about patient care, which, ultimately, may improve the patientcentredness with which this care is delivered. Patient-reported outcomes (PROs), such as quality of life, are increasingly used to measure patients’ well-being and the symptoms they are experiencing.4 PROs are standardized questionnaires that ask patients about symptom severity, physical function, and ability to carry out daily activities.5 There are many methods of collecting PROs; collection of data during regularly scheduled visits is commonly referred to as a “point-of-care” evaluation.6 There are unique considerations when selecting a PRO questionnaire for use at the point of care rather than in a clinical trial. Questionnaires that are too long have been shown to have lower completion rates and affect the validity of responses.6 It should be easy to score the questionnaires quickly so that the results inform communication with patients without affecting clinical workflow.7 Specific to oncologic care, PROs offer several advantages when collected at the point of care, including improved communication between physician and patient; improved health-related quality of life and emotional functioning;7 and improved symptom management,8 such
& 2016 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jcjo.2016.10.005 ISSN 0008-4182/16 CAN J OPHTHALMOL — VOL. ], NO. ], ] 2016
1
Quality of life with uveal melanoma—Kopp et al. as referrals to psychosocial care9,10 or pain management.11 Patients with cancer may benefit from the use of PROs because of their considerable levels of physical and psychosocial distress.12,13 The most relevant PRO questionnaire available for patients diagnosed with uveal melanoma is the 30-item QLQ-OPT30, developed by the European Organisation for Research and Treatment of Cancer (EORTC) Ophthalmic Oncology Task Force.14 As with all EORTC tumourspecific questionnaires, the QLQ-OPT30 is designed to be used with another 30-item questionnaire, referred to as the QLQ-C30, which is generic to all cancer diagnoses.15 There are, however, some limitations to using the QLQOPT30 at the point of care. First, when combined with the QLQ-C30, there are 60 items in total, and thus the questionnaire may be too long to administer in a clinical setting. Second, feedback from patients in a Polish validation study raised questions about the appropriateness of the QLQ-OPT30 when used with some patients.16 Third, patients with uveal melanoma rarely report symptoms such as constipation, diarrhea, appetite loss, nausea, or vomiting,17 and questions on these symptoms constitute the bulk of items in the QLQ-C30. This may reduce the sensitivity of both questionnaires for patients with uveal melanoma, making it difficult to discriminate between patients who report no or few problems with these symptoms.6 As a result of these concerns, this exploratory study set out to address four aims: (i) to understand the issues of quality of life that are most important to patients undergoing brachytherapy for uveal melanoma, (ii) to explore patient views on the QLQ-OPT30 questionnaire, (iii) to assess the length of time to complete the QLQ-OPT30, and (iv) to assess patients’ willingness to complete the questionnaires measuring quality of life on an ongoing basis. We chose to use only the QLQ-OPT30, rather than the QLQ-C30 plus the QLQ-OPT30, for two reasons: (i) the finding by the Polish validation study that many of the items in the QLQ-C30 did not apply; and (ii) guidance from the International Society for Quality of Life Research that recommended questionnaires intended for use at the point of care be brief.18
METHODS Study population and setting
Participants were recruited from the Alberta Ocular Brachytherapy Program at the Royal Alexandra Hospital in Edmonton, Alberta, and the Rockyview Hospital in Calgary, Alberta. All participants had received treatment for uveal melanoma at clinics located in Edmonton or Calgary. Ethical approval for the study was provided by the Health Research Ethics Board of Alberta. Sampling
A series of consecutive patients, over 18 years of age, whose first language was English and who had been
2
CAN J OPHTHALMOL — VOL. ], NO. ], ] 2016
treated for uveal melanoma in the past 3 years, were invited to enroll in the study. The list included patients of both genders and of different ages, who were living at different distances from a clinic location and had varying levels of social and financial support. Interview procedure
A trained interviewer (B.K.) made 3 attempts to reach each patient by phone to set up an interview. Those who agreed to participate underwent a 2-step interview that was scheduled at a time convenient for the participant. Participants were asked to complete the QLQ-OPT30 (following developer instructions and using the 1-week recall time frame) and provide answers based on their current symptoms. Questions in the QLQ-OPT30 were grouped by category: ocular irritation (items 31–36); vision impairment (items 37–39); headaches (item 40); worry about disease recurrence (items 41–43); issues related to appearance (items 44–45); functional problems caused by vision impairment (items 46–51); problems with activities and reading (items 51–52); functional problems in the treated eye (items 53–58); and difficulty driving (items 59– 60). Response options ranged from “not at all” (score of 1) to “very much” (score of 4). A total score was generated by summing the responses to all the questions, with a minimum score of 30 and maximum score of 120; higher scores indicated greater symptom severity. Follow-up questions were asked after completion of each category. For example, after the 6 questions on ocular irritation, the interviewer asked the patient, “Did you experience other types of irritation in your treated eye?” to determine if the questions on ocular irritation encompassed the experiences of the patient. The interviewer then asked the patient, “How much would you say the irritation in your treated eye impacts your quality of life?” These questions, or variants based on the content and previous answers of the patient, were asked for each section. The second step of the interview process involved a semistructured interview, which the interviewer completed immediately after administration of the QLQ-OPT30. In the semistructured interview, the interviewer used a predefined list, or guide, of questions. The guide was followed, but the interviewer asked follow-up questions of the respondent to gather more information or to follow the natural trajectory of the conversation. All comments were recorded by the interviewer in detailed notes. Analysis
Because of the exploratory nature of this study, an inductive analysis approach was undertaken. A thematic content analysis of the patient responses from all components of the interview was conducted. This type of analysis is sufficient for projects that are exploratory in nature or when the goal is to identify key issues of concern for a patient population.19 The interview transcripts were
Quality of life with uveal melanoma—Kopp et al. reviewed, and the participants’ responses were entered into a spreadsheet. Once the data from all of the participants were entered, the responses were reviewed a second time, and themes were identified.
RESULTS Participants
Thirteen participants were contacted by phone and asked to participate, and 10 completed interviews. All who participated in the interviews had received brachytherapy for their uveal melanoma. The mean age of the participants was 52.2 years (range 30–81 years; standard deviation (SD) ¼ 19.6). Three participants were retired, 6 were currently working, and 1 stayed at home as a primary caregiver for children. The mean travel time from home to surgery location (Edmonton) was 280.1 minutes (range 156–573 minutes; SD ¼ 143.1), and the mean travel time from home to nearest clinic location (Calgary or Edmonton) was 153.8 minutes (range 6–476 minutes; SD ¼ 178.6). All participants had been diagnosed with uveal melanoma within the last 3 years (mean 16.3 months; range 5–33 months). All participants were currently receiving ongoing follow-up. Aim 1: Patient perspectives of most important quality-of-life issues
On the basis of the interviews, 5 main themes were identified (see Table 1 for a detailed summary). Three of
the themes were concerned with the more social aspects of well-being: (i) impact on work life, (ii) impact on home life, and (iii) changes to usual daily activities. Themes 1 and 2 were not covered in the QLQ-OPT30. Several participants mentioned a need to make adjustments in their work duties or their workplace arrangements (lighting needs, increasing frequency of breaks during the work day), and 1 participant mentioned a need to change careers as a result of treatment. Participants also mentioned concerns about the impact of treatment on their home life, both in their ability to carry out their normal chores or responsibilities at home, the stress of the diagnosis on their family, and concerns over the financial impacts of time taken off from work or spent on travel for treatments. The third of these social aspect themes, changes to usual daily activities, is present in the existing QLQ-OPT30, but the participants identified other activities that they had difficulty with as a result of their treatment for uveal melanoma, including showering, watching television or movies, and a general fear of being alone that lead to loss in independence. Two other themes were concerned with the healthrelated aspects of well-being: (i) vision impairment and irritation, and (ii) mental health,. Although the QLQOPT30 has 9 items related to vision impairment and irritation, the participants mentioned additional types of impairment and irritation that they had experienced, such as pressure on the eye, drooping of the eyelid, pain, discomfort, and aching in the eye. The participants also
Table 1—Themes that emerged from 10 semistructured interviews about the impacts of uveal melanoma diagnosis and treatment on patient quality of life Theme
Issues
Impact on work life
Not covered in the QLQOPT30
Impact on home life
Not covered in the QLQOPT30
Changes to usual daily activities
Additional issues could be addressed
Vision impairment and irritation
Additional issues could be addressed
Mental health
Additional issues could be addressed
Comments Need to change careers because of change in vision Adjustment of work activities because of changes in vision, including modifications to work environment Taking time off work for treatment and recovery Burden of number of medical appointments Financial burden of treatment Impact of travel for treatment Burden on others to assist with care during treatment (caregiving, driving to medical appointments) Impact of diagnosis on family Burden of number of medical appointments Not being able to perform same chores or responsibilities at home Showering (hard to balance oneself) Watching television or movies Anything that moves eyes from side to side Fear of being alone Loss of independence Pressure on eye, such as a feeling of a suction cup on it Weakened muscles in eye, resulting in drooping Straining of the eye Blurriness Fatigue in eye A feeling of looking through mesh or nylon Sensation of things moving away Pain and discomfort Aching in the eye Mental health of patient Emotional impact of diagnosis How diagnosis is shared with patient Sensitivity of existing questions on recurrence for patients who have already experienced recurrence or metastases Stress resulting from waiting to see specialist and waiting for surgery
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Quality of life with uveal melanoma—Kopp et al. mentioned several aspects of mental health that are not addressed in the QLQ-OPT30, including the emotional impacts of the diagnosis and stress caused by waiting to see a specialist after the initial referral. Aim 2: Performance and patient views of the QLQ-OPT30
On average, it took 22.6 minutes to complete the QLQ-OPT30 and the follow-up questions, and it took 22.4 minutes to complete the semistructured interview. The mean score on the QLQ-OPT30 was 41.9 out of a maximum score of 120 (range 30–54; SD ¼ 8.0). In general, the participants had positive feelings about the survey, indicating that it was “good” and “seemed to cover all the items.” Some participants expressed more negative views about the survey. One stated that the questionnaire was “quite repetitive, especially when a lot of the answers are very little or nothing.” Another participant stated, “They didn’t ask anything about the diagnosis, just the treatment. I find the diagnosis is the hardest hit.” Participants had mixed feelings about the recall time frame of 1 week that is used in the QLQ-OPT30. Some felt that the recall period of 1 week was fine because most of their symptoms were experienced in the first few weeks after surgery. Others felt that the recall period should be longer because their symptoms varied from week to week. Aim 3: Patient feedback on the concept of a PRO questionnaire
All of the participants reported that they would be willing to complete a questionnaire, such as the QLQOPT30, on an ongoing basis. Four participants said that they did not think completing the surveys would improve communication with their doctor because they already had good communication with their doctor, whereas 6 participants felt that completing the survey would be helpful in improving communication. Participants also expressed a desire to have a mechanism that would allow them to express the positives of their treatment, as well as their gratitude for their treatment. This type of feedback would likely not be best expressed in a patient-reported outcome questionnaire, but this does suggest that patients may desire to have a means by which they can share broader experiences and satisfaction.
DISCUSSION This study identified several themes related to quality of life that are important to patients undergoing brachytherapy treatment for uveal melanoma. Notable additions include questions on mental health; impact of diagnosis and treatment on family; burden of treatment on patient and caregivers (including travel and financial commitments); and impact on work and home life. Some of these themes are included in the 30-item generic EORTC
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questionnaire (QLQ-C30). Yet, we do not feel that the administration of a 60-item questionnaire (the sum of the QLQ-OPT30 and the QLQ-C30) at the point of care is practical for the aforementioned reasons. It was also suggested that the time frame of the past 1 week may not be the most appropriate measure, particularly for mental or emotional health and worry about recurrence, which can vary greatly throughout a month. The ideal recall period should be thoroughly explored in future studies. These findings provide some insight into how a PRO could be implemented at the point of care. First, there was a general willingness among the study participants to complete a questionnaire on an ongoing basis, over the course of their care. Second, consistent with scoping reviews of the use of PROs in clinical practice,12 several patients felt completing a questionnaire would improve communication with their physicians. Nine out of 10 participants reported minimal to moderate impacts on quality of life in the various categories of the QLQ-OPT30. One participant mentioned a much higher impact on quality of life in the different categories and especially mentioned that issues such as ocular irritation and limitation of activities could be heightened when they were also feeling frustrated, stressed, or depressed about their diagnosis. All of the participants were in the follow-up stage of their treatment and had healed from acute surgical changes, so the answers to some of the questions could have been different if this questionnaire had been administered closer to the surgery.
Limitations
All of the participants had received brachytherapy for uveal melanoma through 1 clinical program in Alberta, Canada, so the findings may not be representative of all patients undergoing treatment for uveal melanoma. Although certain aspects, such as troubling symptoms, may be more universal among patients, other considerations, such as travel distance for treatment, may not be. It is important to expand the research to a diverse set of patients receiving care in other countries and under different health care systems. The sample did not include anyone who had undergone enucleation or anyone with more limited social support, and only 1 participant had lower financial means. Therefore, the 5 quality-of-life themes identified may not be the most important aspects for all patients undergoing treatment for uveal melanoma at all time points after their treatment. The work reported here supports the need for additional focus groups with a broader range of participants who are undergoing additional treatment types in more than 1 clinical program. Of particular importance is identifying the impacts on quality of life for those patients who report few or no impacts on quality of life and
Quality of life with uveal melanoma—Kopp et al. minimal symptoms as a result of their treatment; this will be key to creating a more sensitive questionnaire.
CONCLUSIONS The results from this pilot study suggest that further work is required to develop a PRO measure for use in patients with uveal melanoma at the point of care. An attempt should be made to gather data from semistructured interview questions at multiple treatment centres to improve generalizability. REFERENCES 1. Singh AD, Turell ME, Topham AK. Uveal melanoma: trends in incidence, treatment, and survival. Ophthalmology. 2011;118:1881-5. 2. Diener-West M, Earle JD, Fine SL, et al. The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma, III: initial mortality findings. COMS Report No. 18. Arch Ophthalmol. 2001;119:969-82. 3. Melia M, Moy CS, Reynolds SM, et al. Development and validation of disease-specific measures for choroidal melanoma: COMS-QOLS report No. 2. Arch Ophthalmol. 2003;121:1010-20. 4. McDowell I. Measuring Health. 3rd ed New York, NY: Oxford University Press; 2006 . 5. Department of Health. Guidance on the Routine Collection of Patient Reported Outcome Measures (PROMs). Ottawa, ON: Department of Health; 2009: 1-28. 6. Fayers P, Machin D. Quality of Life. 2nd ed New York: John Wiley & Sons; 2007 . 7. Bilimoria KY, Cella D, Butt Z. Current challenges in using patientreported outcomes for surgical care and performance measurement. JAMA Surg. 2014;149:505-6. 8. Snyder CF, Aaronson NK, Choucair AK, et al. Implementing patient-reported outcomes assessment in clinical practice: a review of the options and considerations. Qual Life Res. 2012;21:1305-14. 9. Nicklasson M, Elfström ML, Olofson J, Bergman B. The impact of individual quality of life assessment on psychosocial attention in patients with chest malignancies: a randomized study. Support Care Cancer. 2013;21:87-95. 10. Lynch J, Goodhart F, Saunders Y, O’Connor SJ. Screening for psychological distress in patients with lung cancer: results of a clinical audit evaluating the use of the patient Distress Thermometer. Support Care Cancer. 2010;19:193-202. 11. Luckett T, Butow PN, King MT. Improving patient outcomes through the routine use of patient-reported data in cancer clinics: future directions. Psychooncology. 2009;18:1129-38. 12. Howell D, Molloy S, Wilkinson K, et al. Patient-reported outcomes in routine cancer clinical practice: a scoping review of use, impact on health outcomes, and implementation factors. Ann Oncol 2015:1-13. 13. Stein KD, Syrjala KL, Andrykowski MA. Physical and psychological long-term and late effects of cancer. Cancer. 2008;112:2577-92.
14. Brandberg Y, Damato B, Kivelä T, Kock E, Seregard S. The EORTC ophthalmic oncology quality of life questionnaire module (EORTC QLQ-OPT30). Development and pre-testing (Phase I-III). Eye (Lond). 2004;18:283-9. 15. Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85:365-76. 16. Chmielowska K, Tomaszewski KA, Pogrzebielski A, Brandberg Y, Romanowska-Dixon B. Translation and validation of the Polish version of the EORTC QLQ-OPT30 module for the assessment of health-related quality of life in patients with uveal melanoma. Eur J Cancer Care (Engl). 2013;22:88-96. 17. Chabert S, Velikay-parel M, Zehetmayer M. Influence of uveal melanoma therapy on patients’ quality of life: a psychological study. 2004;82:25-31. 18. Reeve BB, Wyrwich KW, Wu AW, et al. ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research. Qual Life Res. 2013;22:1889-905. 19. Green J, Thorogood N. Qualitative Methods for Health Research. 3rd ed. London, UK: Sage Publications Ltd.; 2013.
Footnotes and Disclosure: The authors have no proprietary or commercial interest in any materials discussed in this article. This work was supported by funding from the 2014 Alberta Cancer Foundation Transformative Program and the Canadian National Institute of the Blind. From the nResearch and Evaluation, algoþmed, Calgary, Alb; †Department of Surgery, University of Calgary, Calgary, Alb; ‡Department of Ophthalmology, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alb. Previously presented in poster format at the biannual meeting of the International Society of Ocular Oncology, June 16–19, 2015, in Paris, France, and at the Patient Oriented Summer Research Institute, May 3–4, 2016, in Calgary, Alberta, Canada. Originally received Nov. 24, 2015. Final revision Jul. 2, 2016. Accepted Oct. 31, 2016. Correspondence to Brianna C. Kopp, MPH, algoþmed, 100G-2204 2nd Street SW, Calgary, AB, T2S 3C2, Canada; [email protected]
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