Informed consent for investigational chemotherapy: patients' and physicians' perceptions.

Penman, Doris; Holland, Jimmie C.; Bahna, Geraldine F.; Morrow, Gary R.; Schmale, Arthur H.; Derogatis, Leonard R.; Carnrike, C. L. M.; Cherry, Roxanne

doi:10.1200/jco.1984.2.7.849

Cited by 219 publications

(116 citation statements)

References 4 publications

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“…The positive presentation of trials was reinforced by faith patients place in the decision of their consultants to offer this treatment. Our results with regard to trust in doctors are similar to those obtained by Penman et al (1984) and Daugherty et al (1995). This vulnerable group of patients may be at risk of pressure by their doctors to enter studies, but we found few who did not decide independently to participate.…”

Section: Discussionsupporting

confidence: 85%

“…The published literature on patient motivation to participate in clinical trials suggests that altruism may not be the sole motivating factor; self-interest is also important (Penman et al, 1984;Rodenhuis et al, 1984;Kodish et al, 1992;Daugherty et al, 1995;Itoh et al, 1997;Yoder et al, 1997). A recent systematic review, however, has questioned whether participation in clinical trials is of any benefit to participants (Peppercorn et al, 2004).…”

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confidence: 99%

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Patient motivations surrounding participation in phase I and phase II clinical trials of cancer chemotherapy

et al. 2005

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Successful advances in the treatment of advanced malignant diseases rely on recruitment of patients into clinical trials of novel agents. However, there is a genuine concern for the welfare of individual patients. The aim of this study was to examine motives of patients entering early clinical trials of novel cancer therapies. Questionnaire survey with both open- and close-ended questions. The patients were surveyed after they had given informed consent and before or during the first cycle of treatment. In all, 38 phase I/II trial patients participated and completed the survey. Obtaining possible health benefit was listed by 89% as being a ‘very important' factor in their decision to participate, with only 17% giving reasons of helping future cancer patients and treatment. Other items cited as a ‘very important' motivating factor were ‘trust in the doctor' (66%), ‘being treated by the latest treatment available' (66%), ‘better standard of care and closer follow-up' (61%), and ‘closer monitoring of patients in trials' (58%). Only 47% patients indicated that someone had explained to them about any ‘reasonable' alternatives to the trial. In total, 71% strongly agreed that ‘surviving for as long time as possible was the most important thing (for them)'. Nearly all (97%) indicated that they knew the purpose of the trial and had enough time to consider participation in the trial (100%). In this survey, most patients entering phase I and II clinical trials felt they understood the purpose of the research and had given truly informed consent. Despite this, most patients participated in the hope of therapeutic benefit, although this is known to be a rare outcome in this patient subset. Trialists should be aware, and take account of the expectations that participants place in trial drugs.

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Section: Discussionsupporting

confidence: 85%

mentioning

confidence: 99%

Patient motivations surrounding participation in phase I and phase II clinical trials of cancer chemotherapy

et al. 2005

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“…Therefore, most patients thoroughly understood the major issues of phase I trials after being informed of the potential risks and benefits of the treatment. The possibility of treatment-related risks and side-effects are well recognized after informed consent is given even by patients in phase II1III studies (Penman et al, 1984). It should be emphasized that these results are in accord with those found in a study in the United States (Daugherty et al, 1995).…”

Section: Discussionsupporting

confidence: 69%

“…Some of these reasons might be the small sample size, the minimal variance in age and education in the present sample and the homogenous nature of Japanese culture and society. The majority of the patients even in phase 11/111 studies are aware of the seriousness of their illness (Penman et al, 1984). Although the physician's expectation might influence the patient's attitude (Emanuel, 1995), patients might refuse to accept information they don't wish to hear.…”

Section: Discussionmentioning

confidence: 99%

Patients in phase I trials of anti-cancer agents in Japan: motivation, comprehension and expectations

Itoh

Sasaki²,

Fujii³

et al. 1997

Br J Cancer

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Summary We attempted to characterize the motivation, comprehension and expectations of patients who had given informed consent to participate in phase I trials of anti-cancer agents at the National Cancer Center of Japan. Thirty-three patients were given a simple multiplechoice questionnaire and asked to return it at a later date. The completed survey was returned by 32 patients. The patients were surveyed before they had received any investigational phase agents. Nineteen per cent of patients were motivated to participate in the phase trials by the possibility of therapeutic benefit, 9% because participation seemed a better choice than no treatment and only 6% for altruistic reasons. Most patients comprehended the major features of a phase trial, namely its investigational nature, the unknown effects of the agent investigated and the unclear benefit to the patients themselves. Fifty-nine per cent of the patients anticipated that they might suffer severe or life-threatening side-effects if they participated in the phase trial, and 43% were able to indicate accurately the purpose of the phase trial as a dose determination study. Although only a minority of the patients indicated that their motivation to participate was possible treatment benefit to themselves, when answering questions regarding expectations, more than half indicated that there might be personal benefits of varying degrees by participation.

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“…Among the factors that have been identified for acceptance of trial participation are the hopes that the new treatment will be of benefit to them, and that it will be of benefit to others (Penman et al, 1984;Kardinal, 1994;Slevin et al, 1995). Reasons for declining participation include a preference for a specific treatment arm and fear of randomization (Penman et al, 1984;Llewellyn-Thomas et al, 1991;Jenkins et al, 1999). This paper examines some of the reasons given by patients for accepting or declining entry to different types of randomized trials of cancer therapy and is part of a study being conducted in the UK that aims to improve communication between clinicians and patients when trials are discussed.…”

mentioning

confidence: 99%

Reasons for accepting or declining to participate in randomized clinical trials for cancer therapy

2000

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Summary This paper reports on the reasons why patients agreed to or declined entry into randomized trials of cancer following discussions conducted by clinicians in both District General and University Hospitals. Two hundred and four patients completed a 16-item questionnaire following the consultation, of these 112 (55%) were women with breast cancer. Overall results showed that 147 (72.1%) patients accepted entry to a randomized clinical trial (RCT). The main reasons nominated for participating in a trial were that 'others will benefit' (23.1%) and 'trust in the doctor' (21.1%). One of the main reasons for declining trial entry was that patients were 'worried about randomization' (19.6%). There was a significantly higher acceptance rate for trials providing active treatment in every arm 98 (80.6%) compared with those trials with a no treatment arm 46 (60.5%), χ 2 test P = 0.003. The study outlines a number of factors that appear to influence a patient's decision to accept or decline entry into an RCT of cancer therapy. An important factor is whether or not the trial offers active treatment in all arms of the study. Communication that promotes trust and confidence in the doctor is also a powerful motivating influence.

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Informed consent for investigational chemotherapy: patients' and physicians' perceptions.

Cited by 219 publications

References 4 publications

Patient motivations surrounding participation in phase I and phase II clinical trials of cancer chemotherapy

Patient motivations surrounding participation in phase I and phase II clinical trials of cancer chemotherapy

Patients in phase I trials of anti-cancer agents in Japan: motivation, comprehension and expectations

Reasons for accepting or declining to participate in randomized clinical trials for cancer therapy

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