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Originally published as JCO Early Release 10.1200/JCO.2008.17.5687 on November 24 2008 © 2009 American Society of Clinical Oncology. Does a Patient-Held Quality-of-Life Diary Benefit Patients With Inoperable Lung Cancer?
From the Cancer Epidemiology and Prevention Research Group, Queen's University; and Royal Group of Hospitals, Belfast, United Kingdom Corresponding author: Moyra Mills, PhD, Cancer Epidemiology and Prevention Research Group, Centre for Clinical and Population Sciences, Mulhouse Bldg, RGH Site, Grosvenor Rd, Belfast BT12 6BJ, United Kingdom; e-mail: mmills05{at}qub.ac.uk
Purpose To examine the effect of weekly completion of a patient-held quality-of-life (QOL) diary in routine oncology practice for palliative care patients. Patients and Methods In a pragmatic randomized controlled trial, 115 patients with inoperable lung cancer were randomly assigned to receive either standard care or a structured QOL diary (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and the related lung cancer module LC13) that they completed at home each week for 16 weeks. Patients were encouraged to share the QOL information with health professionals involved in their care. Changes in QOL over time (measured by the Functional Assessment of Cancer Therapy–Lung questionnaire and the Palliative Care Quality of Life Index), discussion of patient problems, and satisfaction with communication and general care were assessed at baseline and at 2 and 4 months after baseline. Results Analysis of QOL indicated a small but consistent difference between patients in the diary group and the standard care group. The diary group had a poorer QOL in many domains. Two different QOL summary scores (total and overall QOL) indicated a statistically significant between-group difference. No effects were found in relation to satisfaction with care, communication, or the discussion of patient problems. Conclusion The regular completion of a QOL questionnaire without appropriate feedback to health care professionals and without the provision of appropriate support may have a negative impact on inoperable lung cancer patients. Further research should focus on identifying features such as feedback loops that are required for the successful and meaningful use of QOL questionnaires in routine patient care.
The routine use of quality-of-life (QOL) measures has been adopted in clinical practice much more slowly than in research. Traditional outcome measures in clinical practice, such as laboratory and radiologic measures, remain dominant, although changes are occurring. The American College of Chest Physicians recommends that, for patients with advanced lung cancer, standardized evaluations of symptom assessments and disease-specific QOL questionnaires be administered by heath care teams.1 In addition, feasibility studies have shown that the introduction of QOL assessment into outpatient clinics is acceptable to patients and clinicians.2-10 Only eight studies in the last decade have investigated the benefits of using a QOL measure in routine oncology practice, and the findings of these studies have been inconsistent. Some studies have shown improved patient-clinician communication,11,12 with positive effects on patient satisfaction12 and QOL,11,13 and better symptom detection and alleviation.14,15 Other studies have found contrary findings.16-18 In addition, no studies have assessed the role of QOL measures across health care settings. This study investigated whether regular recording of QOL data by patients would have beneficial outcomes for those with inoperable lung cancer.
Study Sample and Procedures A prospective randomized controlled study recruited newly diagnosed patients from three hospitals in Northern Ireland. Inclusion criteria included a clinical diagnosis of inoperable lung cancer, ability to give written informed consent, a WHO performance status of 0 to 2, and the ability to complete questionnaires. The study was approved by local research ethics committees, and research governance was granted by each hospital. Senior oncology staff assessed the eligibility of patients at their first appointment, and the study was explained to eligible patients. Patients providing written informed consent were assigned randomly to the diary group or standard care using block randomization with computer-generated random numbers. The intervention involved weekly completion of a QOL questionnaire in a diary format for 16 weeks. The intervention questionnaire was the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and its associated module for lung cancer (Quality of Life Questionnaire LC13). The questionnaire layout was adapted, with permission from the European Organisation for Research and Treatment of Cancer QOL group, to suit an A5 diary format, with each booklet covering a 4-week period. The questions were not altered in any way from the original questionnaire. These questionnaires have been used successfully in other studies of QOL assessment in routine clinical practice.11,12 Patients kept their diary at home and were requested to complete it at a regular time each week and to share the information with any health professional involved in their care. Relevant health care professionals were informed about the study and that patients may wish to share their diary information during consultations. The hospital team received basic training sessions from the researcher on the content and layout of the diary, whereas the primary care team received this information in written form via mail. Training on how to interpret the QOL data was not provided. The standard care group did not receive QOL questionnaires. Sample size was calculated to detect a mean difference in change from baseline of 8 points (standard deviation = 13 points) in the Trial Outcome Index (TOI) subscale of the Functional Assessment of Cancer Therapy–Lung (FACT-L),19 with 80% power at 5% significance (n = 42 patients per group). The TOI is deemed to be the most relevant and accurate indicator of patient-reported QOL for patients with lung cancer.20 A 20% attrition rate was incorporated into the sample size calculation based on rates used in similar studies,11,18 although this proved to be too conservative, and the recruitment period was extended to accommodate a higher attrition rate.
Outcome Measures QOL. The FACT-L questionnaire19,21 was chosen because it has been used extensively in clinical trials and has been deemed valid and reliable in inoperable lung cancer patients. The FACT-L includes 27 general questions divided into four primary QOL domains (physical well-being, social/family well-being, emotional well-being, and functional well-being) and includes a seven-item lung cancer symptom-specific subscale (LCS). The FACT-L also provides other multiple scoring options including a FACT-General (FACT-G) score (physical, emotional, social/family, and functional well-being), a total score (FACT-G plus LCS), and the TOI (physical and functional well-being plus LCS), which is a summary index of physical and functional outcomes. All FACT-L questions are rated on a 5-point Likert scale. Higher scores represent better QOL or fewer symptoms. The Palliative Care Quality of Life Index (PQLI)22 was also used because it was designed specifically for palliative care and covers additional issues of support and communication. The 30 questions in the PQLI are rated on a 3-point Likert scale except the final question, which scores overall QOL on a 10-point scale from poor to excellent. Utilization of the diary. Patients in the diary group recorded in their diary whether or not they shared the diary information with any health professional. Communication and the discussion of patient problems. Patients were asked about general problem areas using an adapted version of the checklist by Velikova et al.4 The checklist asked, "Over the last 2 months did any member of the health care team ask you about..."; this was followed by a list of issues with a yes or no reply. The PQLI section on communication also assessed whether or not social relationships, financial issues, and work and family problems had been discussed. Satisfaction with care. Patients were asked six questions about their expectations and satisfaction with care; these were based on questions used in previous studies in this area.11,12
Statistical Analysis
To highlight clinical relevance, the changes in LCS, TOI, and total FACT-L were categorized as follows: clinically relevant deterioration, no clinically relevant change, and clinically relevant improvement using pre-established clinically meaningful change scores (of 2 to 3 points for the LCS and 5 to 7 points for the TOI and total FACT-L).19 These categoric variables were compared using
Patients were recruited from April 2005 to January 2007; 498 patients were screened, 266 met the inclusion criteria, and 115 gave informed consent (Fig 1). Reasons for ineligibility and not participating are summarized in Figure 1. The most common reason for ineligibility was that patients had a WHO performance status of 3 or more, whereas more than 50% of eligible patients (77 of 151 patients) did not consent because they were too distressed or unwell. Consenting patients were younger than nonparticipants (mean age, 64 v 68 years, respectively; P = .002). There was no statistically significant sex difference; 56% of nonconsenting patients (84 of 151 nonconsenting patients) were male, whereas 61% of consenting patients (70 of 115 consenting patients) were male (P = .32).
Baseline patient characteristics and QOL are listed in Table 1. Groups were comparable regarding age, sex, diagnosis, WHO performance status, treatment received, and baseline QOL scores. Overall, the average age was 64 years, 60% of patients were male, approximately 80% had a diagnosis of non–small-cell lung cancer, more than 60% received chemotherapy, and more than half had a WHO score of 1. The characteristics of patients completing 4-month outcomes are also listed in Table 1. No statistically significant differences were evident between the two groups at month 4.
The mean change from baseline to month 4 and average AUC (adjusting for baseline) are listed in Table 2. Because change score findings for month 2 were similar to those shown for month 4, they have not been presented. Table 2 shows no evidence (P = .14) of a difference in TOI, the primary outcome measure, between the two groups. A significant difference was identified in the secondary QOL outcomes; the mean FACT-L decreased from baseline by 6.3 points in the diary group but increased by 3.5 points in the standard care group (P = .05). Similar differences in overall PQLI QOL score were observed between the two groups using AUC analysis (P = .04). Table 2 also lists the differences in mean scores between groups after adjustment for potentially confounding variables. These adjustments generally made little difference to the findings with exception of FACT-G, where a between-group difference was more evident. Over the 4 months, four summary QOL scores showed a decline in the diary group (TOI = –5.0; total FACT-L = –6.3; FACT-G = –6.6; and overall PQLI = –0.7) compared with one QOL score in the standard care group (overall PQLI = –0.7).
Table 3 lists clinically meaningful change scores for three FACT-L scores. Over the study period, the total FACT-L score deteriorated for a greater proportion of diary group patients compared with standard care patients (52% v 26%, respectively); similarly, the FACT-L score improved for a smaller proportion of diary group patients compared with standard care patients (20% v 48%, respectively).
Only 23% of the diary group (13 of 57 patients) explicitly stated that they had shared their diary with any health care professional. No significant between-group associations at months 2 or 4 were identified regarding the discussion of patient problems with health care professionals. Only month 4 data are presented, with the first seven topics relating to the checklist adapted from previous studies4 and the latter four topics relating to the communication section of the PQLI (Table 4). There seemed to be a trend indicating that the diary group discussed fewer topics with health care professionals than the standard care group. Both groups reported high levels of satisfaction with their care (Table 5), with no significant associations identified, although a slightly higher proportion of standard care patients indicated that they were satisfied.
Overall, the results suggest that weekly completion of a patient-held QOL diary may have a negative effect on some aspects of QOL for patients with inoperable lung cancer. Over the study period, the diary group deteriorated more than the standard care group in all QOL measures, particularly the total FACT-L, FACT-G, and overall PQLI, but these differences were not detected as significant for the primary outcome measure, so they should be interpreted cautiously. These findings contrast with other studies, where regular completion of QOL questionnaires did not have any effect on QOL outcomes12,17,18 or had a positive impact.11 The possibility that more patients in the diary group had progressive disease and that this factor contributed to their poorer QOL is unclear because data on disease progression were not available to the researchers. However, random assignment should have prevented an imbalance, and indeed, no significant differences were detected between the baseline characteristics or treatments received by patients who completed month 4 outcomes, indicating that disease progression is unlikely to have exerted a differential effect. Although improvements in QOL scores for palliative patients, despite their progressive disease and impending death, are not uncommon,24 the apparent decline in the QOL of patients in the diary group requires further consideration. This decline may be related to a number of factors, including raising awareness without sufficient feedback of QOL information to the health care team, a series of negative social and cognitive processes, and a failure to meet raised patient expectations. Previous studies and reviews25-28 have shown that providing clinicians with feedback on patient progress and functional status can improve QOL and patient outcomes. However, a feedback loop did not exist in this study because the majority of patients (67%) did not share their diary information with health care professionals. This factor limited the ability of professionals to intervene and respond to changes in patient QOL. Preliminary work by Velikova et al29 supports the link between a lack of feedback to clinicians and declining QOL. A break in the feedback loop may prevent clinicians from intervening appropriately and may be detrimental for patients. A number of social and cognitive processes may develop in a context characterized by a lack of feedback and absence of appropriate responses from health care professionals. Segerstorm et al30 suggest that repetitive thoughts may lead to worry and rumination. Rumination is a repetitive, aversive, and uncontrollable thought process30 that is strongly linked as a contributory factor to depression in cancer patients.31 It is possible that asking patients to regularly complete a record of how they are feeling, physically and emotionally, may cause them to dwell on their disease progression and to ruminate. The mapping of disease progression may be highlighted further by the fact that each diary contained questionnaires spanning a 4-week period. Furthermore, the arrangement whereby the record was completed and held at home may have provided a greater opportunity to ruminate on the contents. Response shift31 has been used to explain an improvement in an individual's QOL that is not equivalent to their actual physical health status. This change may occur as a result of a process of downward comparison; individuals compare themselves with others that they perceive to be worse off.32 Downward comparison is positively associated with positive feelings and adjustment to disease. In uncontrollable situations, downward comparison can lead to negative rather than positive feelings, when the perceived peer comparison is one's own dreaded future.33 This can be exacerbated by face-to-face contact,34 such as regular encounters at outpatient clinics. In this study, patients with inoperable lung cancer may have perceived themselves to be in an uncontrollable situation. However, it is important to note that the standard care group who were exposed to the same situation might be expected to adopt a similar negative downward comparison. Yet, this process was not evident in their QOL responses, which generally increased over the study period. Standard care patients may have reacted with the more commonly recognized positive response shift in QOL; as their physical condition deteriorated, they recalibrated internal standards used to self-assess their QOL. The completion or noncompletion of a QOL diary may have had a differential impact on the recalibration process undertaken by patients in each group. Another explanation for the decrease in QOL in the intervention group could be raised expectations.35 Measuring QOL in a clinical setting may raise a patient's expectations that a clinician will be able to influence or control their QOL. Patients may possibly be negatively affected by the process of measurement if raised expectations are not met. However, this explanation is unlikely to be valid given the fact that patients did not share the contents of their diary with clinicians and the high levels of patient satisfaction that were recorded. This study did not find that the completion of a QOL diary had any detectable effect on general satisfaction with care, communication between patients and professionals, or the discussion of patient problems. Overall, diary patients seemed to discuss fewer topics with professionals. Satisfaction and communication are complex concepts to define and measure. In this study, assessment was based on the completion of questionnaires by patients, with the majority scoring highly in each area. This study did not use an objective and structured approach to assessment given the fact that patients were seen in various health care settings and by a range of professionals. However, other studies using more comprehensive assessments found similar results.12,36,37 This study differs from previous studies that have evaluated the implementation of QOL assessment in clinical practice because it was not based in one service unit or exclusively in a hospital setting. Opportunities for the researcher to provide detailed education or support to health care staff were limited. Future studies need to be resourced sufficiently to cover the practicalities of implementing QOL across a range of health care settings straddling hospital and community care. Overall, the generalizability of the findings are limited because of the significant proportion of patients who refused to participate, the high attrition rate, and the number of missing items on the questionnaires. Extending the recruitment period compensated for the high attrition rate; however, together with the issue surrounding multiple end points, this may limit the power of the study. The problems encountered during the study illustrate the difficult nature of implementing this kind of research in patients with advanced lung cancer. It is possible, although unlikely, that groups differed in terms of deteriorating performance status and disease status. Disease status was not recorded, but performance status was assessed at baseline, and no significant between-group difference was evident. In addition, random assignment should eliminate bias, although the small sample size by month 4 may have allowed small imbalances between groups. Furthermore, this intervention was designed to be pragmatic and easily transferable to a clinical situation. The findings from this study tend to indicate that the low-tech, low-cost format is not effective and may be counterproductive, at least for inoperable lung cancer patients. In conclusion, weekly completion of a structured, patient-held QOL record, without structured feedback to health care professionals, may have a small negative effect on QOL for patients with inoperable lung cancer. An intervention of this kind with a different patient population and integrated reciprocal feedback may yield a positive outcome. Researchers and clinicians need to note that patients may vary in the nature and extent to which they want to monitor their progress. The study indicates the need for caution and highlights some of the essential components that may be required for the successful implementation of QOL assessment in clinical practice.
The author(s) indicated no potential conflicts of interest.
Conception and design: Moyra E. Mills, Liam J. Murray, Brian T. Johnston, Michael Donnelly Administrative support: Moyra E. Mills Collection and assembly of data: Moyra E. Mills Data analysis and interpretation: Moyra E. Mills, Chris Cardwell Manuscript writing: Moyra E. Mills, Liam J. Murray, Brian T. Johnston, Chris Cardwell, Michael Donnelly Final approval of manuscript: Moyra E. Mills, Liam J. Murray, Brian T. Johnston, Chris Cardwell, Michael Donnelly
We thank the patients who participated in this study and the staff who provided access to patients. We also thank Gordan Cran, PhD, for statistical advice and Angela Scott for data input.
published online ahead of print at www.jco.org on November 24, 2008. Supported by a 3-year PhD fellowship from the Northern Ireland Research and Development Office. Presented in part at the 2007 National Cancer Research Institute Cancer Conference, September 30-October 3, 2007, Birmingham, United Kingdom. Trial Registration: International Standard Randomised Controlled Trial N58789949. Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article. Clinical trial information can be found for the following: ISRCTN58789949 [controlled-trials.com] .
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Taenzer PA, Speca M, Atkinson MJ, et al: Computerized quality-of-life screening in an oncology clinic. Cancer Pract 5:168-175, 1997[Medline] 7. Mullen KH, Berry DL, Zierler BK: Computerized symptom and quality-of-life assessment for patients with cancer part II: Acceptability and usability. Oncol Nurs Forum 31:E84-E89, 2004[CrossRef][Medline] 8. Peruselli C, Camporesi E, Colombo AM, et al: Quality-of-life assessment in a home care program for advanced cancer patients: A study using the Symptom Distress Scale. J Pain Symptom Manage 8:306-311, 1993[CrossRef][Medline] 9. Paci E, Miccinesi G, Toscani F, et al: Quality of life assessment and outcome of palliative care. J Pain Symptom Manage 21:179-188, 2001[CrossRef][Medline] 10. Allenby A, Matthews J, Beresford J, et al: The application of computer touch-screen technology in screening for psychosocial distress in an ambulatory oncology setting. Eur J Cancer Care 11:245-253, 2002[CrossRef] 11. Velikova G, Booth L, Smith AB, et al: Measuring quality of life in routine oncology practice improves communication and patient well-being: A randomized controlled trial. J Clin Oncol 22:714-724, 2004 12. Detmar SB, Muller MJ, Schornagel JH, et al: Health-related quality-of-life assessments and patient-physician communication: A randomized controlled trial. JAMA 288:3027-3034, 2002 13. Hill N: Use of quality-of-life scores in care planning in a hospice setting: The theme of revelation. Int J Palliat Nurs 8:591-593, 2002[Medline] 14. Sarna L: Effectiveness of structured nursing assessment of symptom distress in advanced lung cancer. Oncol Nurs Forum 25:1041-1048, 1998[Medline] 15. Boyes A, Newell S, Girgis A, et al: Does routine assessment and real-time feedback improve cancer patients’ psychosocial well-being? Eur J Cancer Care 15:163-171, 2006[CrossRef] 16. Taenzer P, Bultz BD, Carlson LE, et al: Impact of computerized quality of life screening on physician behaviour and patient satisfaction in lung cancer outpatients. Psychooncology 9:203-213, 2000[CrossRef][Medline] 17. McLachlan SA, Allenby A, Matthews J, et al: Randomized trial of coordinated psychosocial interventions based on patient self-assessments versus standard care to improve the psychosocial functioning of patients with cancer. J Clin Oncol 19:4117-4125, 2001 18. Rosenbloom SK, Victorson DE, Hahn EA, et al: Assessment is not enough: A randomized controlled trial of the effects of HRQL assessment on quality of life and satisfaction in oncology clinical practice. Psychooncology 16:1069-1079, 2007[CrossRef][Medline] 19. Cella D, Eton DT, Fairclough DL, et al: What is a clinically meaningful change on the Functional Assessment of Cancer Therapy–Lung (FACT-L) Questionnaire? Results from Eastern Cooperative Oncology Group (ECOG) study 5592. 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Rubenstein LV, McCoy JM, Cope DW, et al: Improving patient quality of life with feedback to physicians about functional status. J Gen Intern Med 10:607-614, 1995[Medline] 26. Lambert MJ, Whipple JL, Vermeersch DA, et al: Enhancing psychotherapy outcomes via providing feedback on client progress: A replication. Clin Psychol Psychother 9:91-103, 2002[CrossRef] 27. Haywood K, Marshall S, Fitzpatrick R: Patient participation in the consultation process: A structured review of intervention strategies. Patient Educ Couns 63:12-23, 2006[CrossRef][Medline] 28. Greenhalgh J, Long AF, Flynn R: The use of patient reported outcome measures in routine clinical practice: Lack of impact or lack of theory? Soc Sci Med 60:833-843, 2005[CrossRef][Medline] 29. Velikova G, Awad N, Smith AB, et al: Regular quality of life measurement during cancer chemotherapy: Do oncologists need to know? 14th Annual Conference of the International Society for Quality of Life Research Conference, Toronto, Ontario, Canada, October 10-13, 2007 (abstr 1756) 30. Segerstrom SC, Stanton AL, Alden LE, et al: A multidimensional structure for repetitive thought: What's on your mind, and how, and how much?. J Pers Soc Psychol 85:909-921, 2003[CrossRef][Medline] 31. Schwartz CE, Sprangers MA: Methodological approaches for assessing response shift in longitudinal health-related quality-of-life research. Soc Sci Med 48:1531-1548, 1999[CrossRef][Medline] 32. Hagedoorn M, Sneeuw KCA, Aaronson NK: Changes in physical functioning and quality of life in patients with cancer: Response shift and relative evaluation of one's condition. J Clin Epidemiol 55:176-183, 2002[CrossRef][Medline] 33. Major B, Testa M, Bylsma WH: Responses to upward and downward social comparisons: The impact of esteem-relevance and perceived control, in Suls J, Ashby Wills T (eds): Social Comparison. Contemporary Theory and Research (ed 1). Hillsdale, NJ, Lawrence Erlbaum Associates, Inc, 1991, pp 237-257 34. Stanton AL, Danoff-Burg S, Cameron CL, et al: Social comparison and adjustment to breast cancer: An experimental examination of upward affiliation and downward evaluation. Health Psychol 18:151-158, 1999[CrossRef][Medline] 35. Higginson IJ, Carr AJ: Measuring quality of life: Using quality of life measures in the clinical setting. BMJ 322:1297-1300, 2001 36. Cornbleet MA, Campbell P, Murray S, et al: Patient-held records in cancer and palliative care: A randomized, prospective trial. Palliat Med 16:205-212, 2002 37. Frost MH, Bonomi AE, Cappelleri JC, et al: Applying quality-of-life data formally and systematically into clinical practice. Mayo Clin Proc 82:1214-1228, 2007 Submitted April 14, 2008; accepted August 26, 2008.
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Copyright © 2009 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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ABSTRACT
INTRODUCTION
2 tests for trends (to account for the ordering of the categories) between the diary and standard care group. Established clinically meaningful scores were not available for the PQLI. 
