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Randomized Clinical Trials in Oncology: Understanding and Attitudes Predict Willingness to Participate

From the Hamilton Regional Cancer Centre, Hamilton, Ontario, Canada, and Medical Psychology Unit, University of Sydney, Departments of Cancer Medicine and Psychological Medicine, Sydney University, and Sydney Square Breast Clinic, Sydney, New South Wales, Australia.

Address reprint requests to Peter M. Ellis, MBBS, PhD, Hamilton Regional Cancer Centre, 699 Concession St, Hamilton, Ontario, Canada L8V 5C2; email: peter.ellis{at}hrcc.on.ca

	ABSTRACT

TOP ABSTRACT INTRODUCTION MATERIALS AND METHODS RESULTS DISCUSSION REFERENCES

 
PURPOSE: To explore the association at different time points in the trajectory of breast cancer care, between anxiety, knowledge, and attitudes, on women’s willingness to participate in randomized clinical trials.

MATERIALS AND METHODS: A cross-sectional survey was undertaken among women attending a breast clinic for screening mammography or diagnostic assessment plus women with newly diagnosed breast cancer to assess attitudes toward and willingness to participate in randomized clinical trials of breast cancer treatment.

RESULTS: Five hundred forty-five women completed questionnaires assessing knowledge of and attitudes toward randomized clinical trials. The mean age of respondents was 48.9 years (SD, 11.3 years). Thirty-three percent of women would consider participating in a clinical trial if they had breast cancer. Women with breast cancer (31%) were significantly more likely to decline to participate than women attending for screening mammography (15%) or diagnostic assessment (15%, P = .0002). Women who might consider participating in a randomized clinical trial were more knowledgeable about randomized trials (mean difference, 0.7; 95% confidence interval [CI], 0.2 to 1.2; P = .003). In a multivariate analysis, women who would consider participating in a randomized trial were younger (odds ratio [OR], 0.96; 95% CI, 0.93 to 0.99), more likely to want an active role in decision-making (OR, 3.2; 95% CI, 1.3 to 7.6), and reported a greater impact from the positive aspects of clinical trials (OR, 2.2; 95% CI, 1.3 to 3.8) and less impact from the negative aspects of clinical trials (OR, 2.2; 95% CI, 1.3 to 3.2).

CONCLUSION: These findings suggest that women who have a better understanding of issues about clinical trials have more favorable attitudes toward randomized trials and are more willing to consider participation in a clinical trial.

	INTRODUCTION

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IT HAS BEEN ARGUED that participation in well-designed randomized clinical trials offer patients the optimum treatment approach.¹ The treatments offered to control groups in a randomized clinical trial ought to represent the current best standard treatment, while those allocated to the new treatment are receiving a treatment hypothesized to be similarly effective or better. However, less than 3% of patients with common cancers in Australia and North America receive treatment as part of a formal clinical trial.^2,3 As a consequence, the answers to current research questions are delayed and at times the generalizability of the results produced from these trials is called into question.⁴

Greater reliance has been placed on evidence from randomized clinical trials or meta-analyses of randomized clinical trials over the last decade.⁵ In addition, regulatory authorities increasingly require evidence from randomized clinical trials before new therapies or new indications for existing therapies are approved.⁶ This, combined with increasing recognition and acknowledgment of the lower levels of evidence available to support the standard management of many conditions, has seen an increase in the number of randomized trials being conducted.

Previous surveys of cancer patients and the general public have shown general acceptance of the need to include patients in medical research.^7,8 However, a much lower proportion of patients would consider participating personally in a randomized clinical trial.⁷ Patients report a number of reasons for choosing to participate in clinical trials. These include the doctor’s desire for the patient to participate, the chance to obtain new treatments, and the opportunity to contribute to research knowledge and benefit humanity.^9-11 Reasons for declining an invitation to join a clinical trial include a preference for the doctor to make the decision about treatment, concerns about receiving the new treatment, inclusion of a no-treatment arm, discomfort about random allocation of treatment, and a preference to choose their own treatment.^9,12,13

3560However, there has been insufficient research examining the relationship between understanding of and willingness to participate in randomized trials. Llewellyn Thomas et al,¹⁴ comparing different strategies of presenting information about a clinical trial, observed that patients who demonstrated greater knowledge about the trial were less willing to participate in it. Previous research by our group suggested that poor understanding of the need for clinical trials and of the manner in which clinical trials are conducted was a significant barrier to participation.^15,16 Respondents were generally wary about participating in clinical trials, perceiving them as medical experimentation with patients being used as guinea pigs.

A number of demographic characteristics are reportedly associated with willingness to participate in randomized clinical trials. Male patients and patients who are older, less well educated, or from lower socioeconomic backgrounds seem more willing to participate.^11,17,18 Additionally, patients who express greater trust in their doctor seem more likely to participate in randomized clinical trials.¹⁶ These patient groups may also adopt a more passive role in the doctor-patient interaction, preferring to receive less information about their illness and leave decision making to their doctor.^10,19 These issues all raise concerns about the possibility of subtle coercion of such patients to join randomized trials.

In the oncology setting, many patients are invited to participate in clinical trials soon after the diagnosis of their cancer. Patients often report feeling stressed and vulnerable at this time, and there is anecdotal evidence that these feelings may affect patients’ attitudes toward randomized trials.^20,21 This article reports the results of a survey of women attending a breast clinic for either screening mammography or diagnostic assessment and of women with newly diagnosed breast cancer. The research aimed to gain a better understanding of the issues surrounding decision making regarding participation in randomized clinical trials. In particular, it explored the association at different time points in the trajectory of breast cancer care between general willingness to participate in randomized trials and women’s anxiety and knowledge of and attitudes toward clinical trials.

	MATERIALS AND METHODS

TOP ABSTRACT INTRODUCTION MATERIALS AND METHODS RESULTS DISCUSSION REFERENCES

 
All women attending the Medical Benefits Fund (MBF) Sydney Square Breast Clinic (SSBC) for a screening mammogram or diagnostic assessment over a 4-Week period during late 1997 were eligible to participate in the survey. Women who were unable to read English or unable to complete a questionnaire were excluded. Women undergoing treatment for early-stage breast cancer at the Sydney Breast Cancer Institute (SBCI) during 1998 were also eligible for inclusion in this study. Women were approached within 7 days of undergoing a definitive surgical operation for early-stage invasive breast cancer, before seeing a medical oncologist. Women with locally advanced breast cancer treated with initial chemotherapy or radiotherapy were not eligible. Women were also excluded if they had metastatic disease at presentation, were unable to read English, or unable to complete a questionnaire. One woman was not included in the breast cancer survey because she had completed a questionnaire at the breast clinic.

Women were approached by one of the authors (P.M.E.), the purpose of the research was explained, and they were given an information sheet to read. Written informed consent was obtained from women who agreed to complete a questionnaire. Institutional ethics committee approval was obtained from both the Central Sydney Area Health Service Ethics Committee (SBCI) and St Vincent’s Hospital Ethics Committee (SSBC).

The questionnaire was developed using information obtained from focus group interviews¹⁵ in conjunction with a review of the literature.²² The questionnaire was piloted in a sample of patients attending medical oncology outpatient clinics.¹⁶ The questionnaire covered the following areas:

• Demographic data, including age, marital status, education, occupation, ethnicity, and medical/allied health training;
  
• The Hospital Anxiety and Depression Scale (HADS),^23,24 a questionnaire that contains seven items assessing symptoms of anxiety and seven items assessing symptoms of depression. Scores on each scale (range, 0 to 21) are used to classify respondents into three groups (0 to 7 = noncase, 8 to 10 = possible case, and 11 = definite case);
  
• Women’s preferences for the amount of information they wish to receive from their doctor (three-item scale previously described by Cassileth et al²⁵) and their level of involvement in clinical decision-making (five-item scale previously described by Degner et al^19,26);
  
• Knowledge about the need for clinical trials and about the manner in which randomized clinical trials are conducted, which was measured using a seven-item scale developed for this study (Table 1);
  
• Attitudes toward randomized clinical trials, which was measured using a 36-item scale developed from focus group data and a review of the literature that measured the impact of individual items on women’s willingness to participate in randomized clinical trials on a seven-point Likert scale (7 = very likely to join a trial, 4 = would not influence my decision, 1 = very unlikely to join a trial);
  
• General willingness to participate in randomized clinical trials (Table 2); and
  
• Reasons to consider joining/not joining a clinical trial.
  

Sample size calculations were based on the question of whether women’s willingness to participate in randomized trials varied at different time points in the trajectory of breast cancer care (screening, diagnostic assessment, and newly diagnosed breast cancer). As there were larger numbers of women attending either breast clinic, approximately twice as many women were recruited in comparison to women with breast cancer. A sample of 500 women had a power of 0.80 at a significance level of .05 to detect a difference as small as 15% among the three groups of women in their willingness to join a randomized clinical trial.

	RESULTS

TOP ABSTRACT INTRODUCTION MATERIALS AND METHODS RESULTS DISCUSSION REFERENCES

 
Seven hundred twenty-eight women were invited to complete a questionnaire, of whom 602 (83%) agreed and 545 (75%) returned completed questionnaires (Table 3). The demographic details of these women are listed in Table 4. The mean age was 48.9 years (SD, 11.3 years; range, 17 to 87 years). Women attending the breast clinic for diagnostic assessment (mean age, 45.4 years; 95% confidence interval [CI], 43.9 to 47.0) were significantly younger than women attending for screening mammography (mean, 52.1 years; 95% CI, 50.9 to 53.4 years) or women with newly diagnosed breast cancer (mean, 51.3 years; 95% CI, 49.0 to 53.6 years; P < .0001). The only other significant difference among the groups was that women with breast cancer were less likely to work outside the home.

Women attending the clinic for diagnostic assessment (47%) and women with breast cancer (47%) were more likely to be classified as having a possible/definite case of anxiety on the HADS than women attending the clinic for screening mammography (30%, P = .0004). This difference remained when the results were adjusted for age. There was no evidence of any difference in the proportion of women classified as possible/definite cases of depression (women with breast cancer, 13%; women undergoing diagnostic assessment, 7%; women undergoing screening, 5%; P = .08).

The number of correct responses to the knowledge questions (score range, 0 to 7) were summed to give a knowledge score. The mean knowledge score for all respondents was 3.9 (SD, 2.0). There was no significant difference in the mean knowledge scores among women attending for screening mammography (3.8; 95% CI, 3.5 to 4.1), women undergoing diagnostic assessment (3.9; 95% CI, 3.7 to 4.1), and women with breast cancer (4.1; 95% CI, 3.6 to 4.5; P = .52). This was unchanged when the results were adjusted for age.

Women’s attitudes toward randomized clinical trials were assessed using a 36-item scale. The scale had high internal reliability (Cronbach alpha, 0.96). A principal components factor analysis with varimax rotation was conducted. A four-factor solution (Table 5) emerged explaining 60% of the variance in respondent’s attitudes toward clinical trials. These four factors seemed to measure (1) women’s perception of the positive aspects of participating in clinical trials, (2) their perception of the negative aspects of participating, (3) their perceptions of practical issues/inconvenience associated with participating in clinical trials, and (4) altruism. The standardized factor scores for the four factors are shown in Fig 1. Women with newly diagnosed breast cancer had significantly lower scores for all four factors (P < .001 for each factor), which indicates less favorable attitudes toward randomized clinical trials.

View larger version (87K): [in this window] [in a new window]   Fig 1. Bar graph of the four factor scores for the three groups of women (, screening; , diagnostic; , breast cancer).

Women who might consider participating in a clinical trial ("yes" and "don’t know" groups combined) had higher mean knowledge scores about clinical trials than women who were not prepared to join a clinical trial (mean difference, 0.7; 95% CI, 0.2 to 1.2; P = .003). There was no evidence of any association between either anxiety or depression and women’s willingness to join a clinical trial.

Women were asked to indicate three reasons (in order of importance) why they would and would not consider participating in a randomized clinical trial. The responses were weighted (first reason scored 3, second reason scored 2, and third reason scored 1) to give more importance to the top reason. The weighted scores were then summed to determine the most important reasons. The responses for the whole sample are listed in Table 7. The major reasons to consider participating in a randomized clinical trial were possibility for a greater chance of cure, furthering medical research, and benefiting others. These findings were the same for all three groups. The main reasons (among the whole sample) for declining to participate were possibility that side effects may be worse on the trial, the treatment may be worse, and the doctor may not know as much about the treatment. However, women with breast cancer cited that the clinical trial would feel like a gamble and they would prefer to choose the standard treatment as reasons for declining trial participation.

A multivariate analysis was conducted to further explore these findings. The results are listed in Table 8. Older women were less willing to consider joining a clinical trial (odds ratio [OR], 0.96; 95% CI, 0.93 to 0.99). Women who wanted to adopt an active role in decision making (OR, 3.2; 95% CI, 1.3 to 7.6) were more willing to join clinical trials than women who wanted a collaborative (OR, 1.3; 95% CI, 0.58 to 2.9) or passive (OR, 1.0) role in decision making. Women who reported a greater impact from the positive aspects of clinical trials (OR, 2.2; 95% CI, 1.3 to 3.8) and less impact from the negative aspects of clinical trials (OR, 2.2; 95% CI, 1.3 to 3.2) were significantly more willing to join a clinical trial. There was a trend suggesting that women who reported greater impact of altruistic motivations were more willing to join a clinical trial (OR, 1.6; 95% CI, 0.91 to 2.9). Univariate analysis suggested that a new diagnosis of breast cancer was associated with reduced willingness to join a randomized clinical trial. However, this association was no longer significant after adjustment for other variables.

	DISCUSSION

TOP ABSTRACT INTRODUCTION MATERIALS AND METHODS RESULTS DISCUSSION REFERENCES

These findings support the assertion by Baum³⁰ that there is a need to educate the general public about the need for clinical trials and about the manner in which randomized trials are conducted. This may help to reduce some of the concerns that result from discussions about clinical trials soon after a cancer diagnosis. Many women indicated that they would be more willing to join a clinical trial that was endorsed by organizations such as the National Breast Cancer Centre or the New South Wales Cancer Council. Greater thought needs to be given to how these organizations and health service management might fulfil this advocacy role, although such attempts should also look to involve patient advocacy groups.

Only one in three respondents to this survey was prepared to join a clinical trial. This figure may be even lower, as approximately 20% of women approached about the survey were not interested in completing a questionnaire. It seems plausible that these women would also be less inclined to participate in a randomized trial. The proportion of women who would consider trial participation is lower than that reported in a number of other studies.^7,9,31 However, women in this study either had breast cancer or were asked to imagine they had recently been diagnosed with breast cancer when responding to the questionnaire. The lower rates observed in this study may be explained in part by greater feelings (actual or perceived) of insecurity surrounding a new cancer diagnosis. This notion is supported by the fact that women with newly diagnosed breast cancer had less favorable attitudes toward randomized trials and were twice as likely to decline to participate in a clinical trial compared with women attending clinics for screening mammography or diagnostic assessment.

It was hypothesized that these differences in willingness to participate may be mediated through increased anxiety levels associated with a new cancer diagnosis. However, no differences in anxiety levels were observed between women who would consider joining a clinical trial and those who would not. The observed differences would seem to be explained through differences in women’s attitudes toward randomized trials. Women with newly diagnosed breast cancer had significantly less favorable attitudes toward randomized clinical trials than women attending either of the breast clinics. A new cancer diagnosis induces a variety of emotional responses. Avoidance of additional uncertainty associated with participation in randomized clinical trials may be a protective mechanism to cope with the fear and uncertainty associated with a cancer diagnosis.

Women’s reasons for considering entry onto a randomized clinical trial were similar to those reported previously in the literature.^9,10 The possibility of receiving a better treatment and the prospect of advancing medical knowledge seem to be major motivating factors. The findings of this study suggest that concerns about the uncertainty and experimental nature of a clinical trial (possibility of additional side effects, treatment may be worse, less known about the treatment, feels like a gamble) are the major reasons for deciding not to join a trial. These findings support the view that the women with breast cancer in this study were reluctant to participate in a clinical trial to avoid additional uncertainty about treatment options. However, a recent study by Jenkins and Fallowfield¹³ found that the main reasons for deciding not to join an actual clinical trial reflected concerns about treatment allocation (worried about randomization, want the doctor to choose treatment). These differences may reflect cultural differences. However, they may also suggest that the issues surrounding decision making for entry onto clinical trials differ for patients considering participation in clinical trials in general and patients considering participation in a specific clinical trial.

Some institutions are clearly more successful at recruiting patients onto randomized clinical trials. In the study by Jenkins and Fallowfield,¹³ 72% of patients accepted entry onto a randomized clinical trial. It is likely that the decision to participate in a clinical trial represents a complex interaction between physician and patient. One of the fundamental ethical issues surrounding clinical trials reflects a conflict between the need to safeguard individual patients versus the obligation to society to facilitate research.^32,33 Well-designed randomized trials provide a high standard of care; however, there are times when patients receiving the experimental arm of the trial may ultimately receive less effective treatment. Although the results of this study suggest that patients who would consider joining a trial are more active participants in the doctor-patient consultation, there is a need for additional research examining how doctors communicate information about clinical trials to potential participants.

In the interim, when a randomized clinical trial is available at an institution, it should be presented as one of the standard treatment options to all patients. However, physicians should be aware that patients may not have a good understanding about procedural aspects of clinical trials. Additionally, stress associated with a new cancer diagnosis may have a negative impact on patients’ attitudes about a trial. Therefore, it is important for the physician to take the time to elicit and address patients’ concerns and understanding about a clinical trial.

	ACKNOWLEDGMENTS

 
P.M.E. was supported by a postgraduate scholarship from the National Health and Medical Research Council of Australia from 1997 to 1999.

	NOTES

 
Women attending for breast screening or diagnostic assessment were recruited through the Medical Benefits Fund, Sydney Square Breast Clinic.

	REFERENCES

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Submitted January 9, 2001; accepted April 26, 2001.

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