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Originally published as JCO Early Release 10.1200/JCO.2006.08.9367 on May 29 2007 © 2007 American Society of Clinical Oncology. Assessment of Care by Breast Cancer Patients Participating or Not Participating in a Randomized Controlled Trial: A Report With the Patients' Committee for Clinical Trials of the Ligue Nationale Contre le Cancer
From the Institut National de la Santé et de la Recherche Médicale, U379, Epidemiology and Social Sciences Unit; Aix Marseille Université, Faculté des Sciences/de Médecine; Paoli-Calmettes Institute, Marseille; Fédération Nationale des Centres de Lutte contre le Cancer, Paris; Claudius Regaud Institute, Toulouse; André Boulloche Centre, Montbéliard; Eugène Marquis Centre, Rennes; Antoine Lacassagne Centre, Nice; Sainte Catherine Institute, Avignon; and the Alexis Vautrin Centre, Vandoeuvre-Lès-Nancy, France Address reprint requests to Claire Julian-Reynier, MD, Institut National de la Santé et de la Recherche Médicale, U379, 232 Bd Ste Marguerite,13273 Marseille Cedex 09, France; e-mail: julian{at}marseille.inserm.fr
Purpose Cancer patients participating in randomized controlled trials (RCTs) have not been found to have better clinical outcomes than other patients. Our objective was to assess the impact of RCTs on patients' satisfaction with care. Patients and Methods A prospective study was carried out in a cohort of women with breast cancer (N = 455) divided into those invited to participate in an RCT (201 acceptances, 66 refusals) and a comparable control group not invited to participate (n = 188). All the patients underwent the same treatment (fluorouracil, epirubicin, and cyclophosphamide 100 mg/m2 for six cycles). One and 7 months after the beginning of chemotherapy, self-administered satisfaction scores were used to compare the women's assessment of their care (Comprehensive Assessment of Satisfaction with Care validated scale).
Results At the beginning of chemotherapy, women to whom RCT had been proposed rated the doctors' availability (average ± standard deviation [SD]: RCT acceptance group, 3.60 ± 0.78; RCT refusal group, 3.68 ± 0.87; control group, 3.41 ± 0.82; P Conclusion Women participating in an RCT have a more positive picture of their doctors' care than others, probably because of the structural effects of the informed consent and data collection processes.
Despite the widespread belief that enrollment in clinical trials leads to improved outcomes among cancer patients, the data available do not definitely show that participating in clinical trials has positive effects of this kind.1,2 Among patients with cancer, there is scant information in the literature on the impact of clinical trials participation on patients' reporting of satisfaction with the care received. The concept of satisfaction with care has been criticized during the past 20 years3-6 after being introduced into the health care assessment field in the early 1980s. However, as long as the necessary methodologic precautions are taken, satisfaction with care seems to be a useful index in the field of oncology.7 Patients' satisfaction rates, as assessed in quantitative surveys and via questionnaires, were found to be systematically high because the multidimensional characteristics of satisfaction were not always taken into account and the answers were not always rated on appropriate measurement scales. Several factors have been thought to account for patients' satisfaction and dissatisfaction. There is no continuum from satisfaction to dissatisfaction, since the determinants differ in both cases. Patients' own assessment of the care received seems to be a more appropriate term for describing patients' experience of care than the term satisfaction,6 although this issue is still being debated.8 Therefore, the aim of this study was to compare how breast cancer patients with similar medical characteristics who underwent the same treatment and who participated or did not participate in a randomized controlled trial (RCT) assessed their care. We assumed that patients who took part in RCTs would probably be given more standardized information and a higher standard of care because of the process of informed consent, the systematic monitoring of treatment, and the adverse effects required for RCT data collection purposes. Patients included in a clinical trial are therefore likely to assess the care received more positively and to be more satisfied with their medical management than others. To our knowledge, no previous studies have explored this issue.
Patients This study was carried out at 16 specialized French centers. Forty-eight oncologists participated in the study, which was performed on adult women undergoing treatment for nonmetastatic breast cancer (inclusion between February 2002 and August 2004). These women formed three groups: one group was made up of participants in two phase III, open, multicenter trials who were randomly assigned in the standard treatment arm of the trials (RCT acceptance group), the second group was made up of women who refused to participate in these trials (RCT refusal group), and the third group were women to whom the trial was not proposed (control group). One of the RCT trials was designed to test the efficacy of combined docetaxel and epirubicine treatment (six cycles) and the other one was designed to test the efficacy of four cycles of fluorouracil, epirubicin, and cyclophosphamide (FEC) 100. After undergoing primary surgery, the women were all undergoing the same standard chemotherapy regimen (six cycles of FEC 100) followed by radiotherapy.9 Other inclusion criteria were primary breast adenocarcinoma with histologic confirmation, age between 18 and 65 years, and performance status lower than 2 (Eastern Cooperative Oncology Group scale).10 Exclusion criteria were the existence of a suspected lesion in the contralateral breast, metastasis, International Union Against Cancer stage pT4a, contraindications for anthracyclines, and previous occurrence of cancer.
Study Design and Process This study was approved by the National Committee on Personal Data and Privacy (Comité National Informatique et Libertés).
Medical, Sociodemographic and Psychological Characteristics
Comprehensive Assessment of Satisfaction With Care
Statistical Analysis We compared respondents and nonrespondents by performing univariate and multivariate (stepwise logistic regression) analyses. The sociodemographic and psychological data obtained on each group were compared by performing univariate analyses. Each group was compared with each of the two other groups, using t-tests on the mean scores obtained on the nine CASC subscales at 1 and 7 months. Paired t-test and covariance analysis, with a group effect included, were used to assess the significance of changes with time in the satisfaction subscores. We made univariate comparisons to determine what other sociodemographic/psychological factors might be associated with satisfaction. Center-related effects and first order interactions were also investigated. In the case of the seven satisfaction subscores where a significant group effect was observed at month 1 or 7, multivariate adjustment was performed via hierarchical linear modeling of the effects of individual variables (first level, fixed variables) nested in the center effect (second level, random effect; Hierarchical Linear and Nonlinear Modeling, version 6.0; Scientific Software International, Lincolnwood, IL).16 The individual variables included in the multivariate adjustment were those found to be significant at P < .10 in the univariate comparisons. The existence of colinearity was checked by performing univariate analysis between explanatory variables. Anxiety and depression were highly correlated and only depression was therefore included in the multivariate analyses.
Characteristics of the Study Population Among the 676 consecutive women contacted for the survey, 34 were eventually excluded (age > 65, time elapsing since surgery > 120 days, previous cancer). Among the 642 women definitely included, 455 (70.9%) agreed to participate and answered the first questionnaire. After multivariate adjustment, center size (adjusted odds ratio [OR], 1.6; 95% CI, 1.1 to 2.4; P = .016) and length of consultations (OR, 1.019; 95% CI, 1.004 to 1.034; P = .013) were found to be independent predictors of willingness to participate. Other characteristics, such as age and group, were not. Among the respondents, 267 were invited to participate in an RCT: 201 agreed and have been labeled the RCT acceptance group, while 66 refused and have been labeled RCT refusal group. The third group, which was called the RCT control group, included 188 consecutive women. No statistical differences were observed between the sociodemographic and psychological characteristics of the patients in the three groups (Table 1). Time elapsing since surgery was the main reason for not including patients in the RCT group (Table 1); other reasons were surgical difficulty in meeting the RCT inclusion criteria (n = 21) and lack of time (n = 3). Time elapsing since surgery was not significantly associated with the satisfaction subscores.
Sociodemographic Characteristics The mean age of the respondents (N = 455) was 49.8 years (SD = 8.5 years). Three hundred fifty-seven women were living with a partner (79.9%), 337 had an occupational activity (74.1%), and 244 were educated to at least high school level (53.6%). Details are provided in Table 1.
Satisfaction With Cancer Care at the Beginning of Chemotherapy
Differences in Satisfaction Among Women Participating or Not Participating in an RCT During chemotherapy, the satisfaction subscores about doctors' availability and communication skills differed between women to whom RCT was proposed (and who either agreed or refused to participate) and the control group (Table 2). There were no significant differences in these two scores between women accepting and refusing the RCT. Details of the subscore items (Table 2) show that frequency of visits, coordination of care, and information about the illness/treatment were rated more highly by those who had been invited to participate in the RCT than by those who were not (Table 2). There were no statistical differences between groups in terms of the other seven satisfaction subscores.
Satisfaction With Cancer Care After the Complete Sequence of Treatment The second questionnaire was completed on average 7.4 months (222 days; SD = 17) after the beginning of chemotherapy. In the total sample, similar trends to those detected at the beginning of chemotherapy were observed in all the subscores, but they all reflected significantly lower satisfaction levels than the first assessments (Fig 1). The analyses (paired t-tests) showed that all the subscores of satisfaction decreased significantly with time for every group except for the global subscore for the RCT group (Fig 2). The analyses of covariance showed the existence of significant differences in the patterns of response observed with time between the RCT group and the control group in the case of three subscores: doctors' interpersonal skills (P = .029), doctors' communication (P = .049), and general satisfaction (P = .034; Fig 2). They also showed that the RCT refusal group had higher decreases in their satisfaction about doctors' interpersonal skills (P = .023), doctors' technical skills (P = .019), and doctors' communication (P = .017) than the RCT group. None of the decreases differed significantly between the RCT refusal group and the control group (Fig 2).
Differences in Satisfaction Among Women Participating or Not Participating in an RCT At month 7, women who participated in the RCT were more satisfied than the women in the control group with the doctors' availability, interpersonal, and communication skills, and the general care they received (Table 3). Details of the significant items corresponding to these subscores (Table 3) show that access to consultations and the answers given to questions about difficulties, the interest and support received, and physicians' information about treatment/illness were more highly rated by the women who joined the RCT than those in the control group. Satisfaction with information about treatment, confidence in being treated at this particular hospital, and recommendation of this particular hospital were also more highly rated by women who participated in the RCT than those in the control group. Similar trends were observed between the RCT acceptance and the RCT refusal groups, but they were mostly borderline significant (Table 3).
Multivariate Adjustment Multivariate adjustment showed the independent effect of the inclusion group (RCT acceptance, RCT refusal, control) on the satisfaction subscores obtained on doctors' availability and communication skills at month 1, after adjusting for significant covariates (depression, social support, educational background) and center. At month 7 after adjusting for the effects of significant covariates (depression, social support) and center, this multivariate adjustment also confirmed that satisfaction with doctors' interpersonal and communication skills and general satisfaction were higher among women who had participated in the RCT than among those who had not participated.
To our knowledge, this is the first prospective study on patients' assessment of their satisfaction with medical care showing an improvement in satisfaction among patients participating in RCTs. These comparisons were carried out twice: at the beginning of chemotherapy and after the whole sequence of treatment (ie, after radiotherapy). At the beginning of chemotherapy, women who had been invited to participate in the RCT assessed the coordination of care and the information delivered by their oncologist about their illness and treatment more positively than women to whom the trial had not been proposed. After the whole treatment, women who participated in the RCT felt they had benefited from a more supportive relationship with their doctor and assessed the information delivered more positively than women who had not been given the possibility of participating in the trial. Women included in the trial assessed the information delivered by the doctors about their illnesses and treatments more positively both at the beginning of chemotherapy and after the whole sequence of treatment than women who had not been offered the possibility of participating in the trial. This may have been due to the existence of the informed consent process associated with cancer clinical trials.17,18 As presented in Table 3, differences in these variables between participants and refusers at the end of treatment were only marginally significant, possibly because the refusers group was so small. At the beginning of chemotherapy, women to whom the RCT was proposed and who either accepted or declined the offer rated the coordination of care between doctors and between doctors and nurses more highly than the others. They were also more satisfied with the frequency of their visits than the women to whom the RCT was not proposed, and more satisfied with their doctors' supportiveness. The coordination of care has been found to be one of the keys to the quality of care, as assessed by oncology patients, since it was rated as high as the quality of communication of information, and these two issues were related.19 Since the treatment process involves health care specialists of at least three kinds (surgeon, oncologist, radiotherapist), doctors' coordination, and doctors' and nurses' coordination is a really important issue. On the whole, the highest satisfaction score was the general one, which confirms the idea that high satisfaction ratings are obtained when they are not specific. High satisfaction rates were obtained on technical aspects of the care dispensed by either doctors or nurses; whereas the lowest scores focused on interpersonal relationships (Fig 1). High satisfaction ratings were previously obtained on general and technical points in a different context with the CASC scale.20 In other studies in which the overall providers' care was rated, satisfaction with nurses' care was higher than with doctors' care.21 It is worth noting here that patient's ratings of specific tasks and roles tend to differ more than between providers on the whole. A doctor or a nurse can be excellent at one skill and less efficient at other levels. Satisfaction scores decreased over time, especially in the RCT refusal group (Fig 2). It has been established that the psychological profiles can differ between those who refuse and those who accept a trial, possibly because refusers are more demanding about their care than other patients.22 This study had several limitations. First, we did our best to ensure that the same inclusion criteria were used for all the groups. However, there existed some minor clinical differences, such as the time elapsing from surgery to chemotherapy, which had no effect on the satisfaction process. Second, the RCTs were not blind trials, and the women included in our survey were aware that they were given only the standard treatment. Therefore, they may have been less satisfied than those in the experimental arm, since one of the reasons why women agree to participate in RCTs is known to be that it gives them access to a new treatment.22 This means that we cannot generalize the conclusions reached here about the satisfaction levels of the women in the experimental arm, but at least our comparisons between women who did or did not participate in an RCT cannot have been biased by the treatment. Third, although satisfaction with some of the aspects was statistically significantly higher among the women included in RCTs, the clinical significance of these differences can be discussed in terms of their relevance to modify routine practices. Lastly, the nonsignificant statistical results obtained with the RCT refusal group should be interpreted with caution because of the lack of power of statistical comparisons involving such a small group. This results show that women, whether they were in the acceptance or refusal group of an RCT were more satisfied with their doctors' care at the beginning of treatment than those not given the opportunity of participating. At the end of treatment (in general), however, those in the acceptance group showed greater satisfaction than those in the refusal group or those not given the opportunity of participating in an RCT. The main explanation for the positive effects of participating in RCTs is probably that participants benefit from the effects of the informed consent process, the regular data collection process, and medical consultations required to be able to assess the efficacy and adverse effects of drugs during the follow-up period. Further studies are now required to confirm these findings. The standardized methods of information delivery and data collection used in RCTs could possibly be used as an example to improve the level of satisfaction among patients not participating in clinical trials.
The author(s) indicated no potential conflicts of interest.
Conception and design: Claire Julian-Reynier, Jean Genève, Florence Dalenc, Dominique Genre, Alain Monnier, Pierre Kerbrat, Rémy Largillier, Daniel Serin, Maria Rios, Henri Roché, Marta Jimenez, Carole Tarpin, Dominique Maraninchi Administrative support: Claire Julian-Reynier, Jean Genève, Marta Jimenez Provision of study materials or patients: Claire Julian-Reynier, Florence Dalenc, Dominique Genre, Alain Monnier, Pierre Kerbrat, Rémy Largillier, Daniel Serin, Maria Rios, Henri Roché, Carole Tarpin Collection and assembly of data: Claire Julian-Reynier, Jean Genève, Marta Jimenez Data analysis and interpretation: Claire Julian-Reynier, Jean Genève, Florence Dalenc, Dominique Maraninchi Manuscript writing: Claire Julian-Reynier, Dominique Maraninchi Final approval of manuscript: Claire Julian-Reynier, Jean Genève, Florence Dalenc, Dominique Genre, Alain Monnier, Pierre Kerbrat, Rémy Largillier, Daniel Serin, Maria Rios, Henri Roché, Marta Jimenez, Carole Tarpin, Dominique Maraninchi
We are indebted to the patients on the Patients' Committee for Clinical Trials of the Ligue Nationale Contre le Cancer and to Françoise May-Levin, Jean-Pierre Escande, and Marie Lanta who participated actively in defining the aims of the present study. We thank also the centers in Auxerre (Centre Hospitalier [CH]), Besançon (Centre Hospitalier Universitaire), Caen (Centre François Baclesse), Dijon (Centre Georges-François Leclerc), Lagny (CH), Le Havre (CH, Clinique des Ormeaux), Rodez (CH), and Saint Herblain (Centre René Gauducheau) for participating in this study. We thank Julien Mancini and Françoise Chabal for their technical help and Jessica Blanc for revising the English translation of the manuscript.
published online ahead of print at www.jco.org on May 29, 2007. Supported by the Ligue Nationale Contre le Cancer, the Fondation de France, and the Fédération Nationale des Centres de Lutte Contre le Cancer. Presented in part in poster format at the 41st Annual Meeting of the American Society of Clinical Oncology, Orlando, FL, May 13-17, 2005. Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.
1. Peppercorn JM, Weeks JC, Cook EF, et al: Comparison of outcomes in cancer patients treated within and outside clinical trials: Conceptual framework and structured review. Lancet Jan 24363263-270, 2004 2. Vist GE, Hagen KB, Devereaux PJ, et al: Systematic review to determine whether participation in a trial influences outcome. Bmj 330:1175, 2005 3. Carr-Hill RA: The measurement of patient satisfaction. J Public Health Med Sep 14:236-249, 1992 4. Williams B: Patient satisfaction: A valid concept? Soc Sci Med 38:509-516, 1994[CrossRef][Medline] 5. Williams B, Coyle J, Healy D: The meaning of patient satisfaction: An explanation of high reported levels. Soc Sci Med Nov 47:1351-1359, 1998[CrossRef] 6. Staniszewska S, Henderson L: Patients evaluations of their health care: The expression of negative evaluation and the role of adaptive strategies. Patient Educ Couns 55:185-192, 2004[CrossRef][Medline] 7. Bredart A, Bouleuc C, Dolbeault S: Doctor-patient communication and satisfaction with care in oncology. Curr Opin Oncol 17:351-354, 2005[CrossRef][Medline] 8. Hendriks AA, Vrielink MR, van Es SQ, et al: Assessing inpatients' satisfaction with hospital care: Should we prefer evaluation or satisfaction ratings? Patient Educ Couns 55:142-146, 2004[CrossRef][Medline] 9. Bonneterre J, Roche H, Kerbrat P, et al: Epirubicin increases long-term survival in adjuvant chemotherapy of patients with poor-prognosis, node-positive, early breast cancer: 10-year follow-up results of the French Adjuvant Study Group 05 randomized trial. J Clin Oncol 23:2686-2693, 2005 10. Zubrod C, Schneiderman M, Frei E: Appraisal of methods for the study of chemotherapy of cancer in man: Comparative therapeutic trial of nitrogen mustard an triethylene thiophosphoramide. J Chronic Dis 11:7-33, 1960[Medline] 11. Fuhrer R, Rouillon F: French version of the CES-D (Center for Epidemiologic Studies-Depression Scale): Description and transduction of the self-administered scale [French]. Psychiatrie et psychobiologie 4:163-166, 1989 12. Spielberger C: Assessment of state and trait anxiety: Conceptual and methodological issues. The Southern Psychologist 2:6-16, 1985 13. Micallef J, McGlangeaud-Freudenthal N, Aurran Y, et al: Measurement of anxiety state in women: A short-form scale. Rev Epidemiol Sante Publique 46:383-389, 1998[Medline] 13. Mancini J, Geneve J, Dalenc F, et al: Personal experience, decision making and cancer clinical trials: A prospective study. Contemporary Clincial Trials (in press) 14. Bredart A, Razavi D, Robertson C, et al: A comprehensive assessment of satisfaction with care: Preliminary psychometric analysis in French, Polish, Swedish and Italian oncology patients. Patient Educ Couns Jun 43:243-252, 2001[CrossRef] 15. Bredart A, Robertson C, Razavi D, et al: Patients' satisfaction ratings and their desire for care improvement across oncology settings from France, Italy, Poland and Sweden. Psychooncology 12:68-77, 2003[CrossRef][Medline] 16. Localio AR, Berlin JA, Ten Have TR, et al: Adjustments for center in multicenter studies: An overview. Ann Intern Med 135:112-123, 2001 17. Joffe S, Cook EF, Cleary PD, et al: Quality of informed consent: A new measure of understanding among research subjects. J Natl Cancer Inst 93:139-147, 2001 18. Steimes P, Edouard A, Monnot F, et al: Involving patients in clinical trial design. Appl Clin Trials 9:93-94, 1999 19. Schrag D: Communication and coordination: The keys to quality. J Clin Oncol 23:6452-6455, 2005 20. Bredart A, Razavi D, Robertson C, et al: A comprehensive assessment of satisfaction with care: Preliminary psychometric analysis in an oncology institute in Italy. Ann Oncol 10:839-846, 1999 21. Bredart A, Bottomley A, Blazeby JM, et al: An international prospective study of the EORTC cancer in-patient satisfaction with care measure (EORTC IN-PATSAT32). Eur J Cancer 41:2120-2131, 2005[CrossRef][Medline] 22. Jenkins V, Fallowfield L: Reasons for accepting or declining to participate in randomized clinical trials for cancer therapy. Br J Cancer 82:1783-1788, 2000[CrossRef][Medline] Submitted August 31, 2006; accepted April 20, 2007.
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Copyright © 2007 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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ABSTRACT
INTRODUCTION
.02) and the doctors' communication (average ± SD: RCT acceptance group, 3.56 ± 0.88; RCT refusal group, 3.67 ± 0.88; control group, 3.39 ± 0.84; P 
, 0.92)
2 tests were used to compare percentages, t-tests were used to compare two means, and one-factor variance analysis was used to compare more than two means. 
