Participants' perceptions of a phase I colon cancer chemoprevention trial

doi:10.1016/S0197-2456(96)00063-3

Controlled Clinical Trials

Volume 17, Issue 6, December 1996, Pages 494-508

https://doi.org/10.1016/S0197-2456(96)00063-3 Get rights and content

Abstract

To assess participants' perceptions of a phase I colon cancer chemoprevention trial using a calcium intervention, questionnaires were mailed to trial participants at the conclusion of the study. Responses to questionnaire items reported here include (1) perceived benefits and barriers of participation, (2) interest in participating in future trials, (3) willingness to pay trial expenses out of pocket, and (4) posttrial continuation of the calcium regimen. The study found that the most highly rated trial benefit was the perception of potential colon cancer prevention; the trial barrier reported to be the most troublesome was inappropriate or mistaken billing for study visits. Three fourths of the subjects expressed an interest in future trials of the same duration. For trials of longer duration, this percentage decreased to 66%. Approximately half did not object to participation in future trials involving placebos, and just over one third indicated that they would either definitely (8%) or probably (27%) have joined the calcium trial even if they had to pay some study expenses out of pocket. Over 90% indicated they would continue taking the calcium pills if calcium is shown to be effective. The level of perceived benefits was positively associated with reported interest in participating in future trials of the same and longer durations, and the level of reported difficulty with trial pills and procedures was inversely related to interest in future placebocontrolled trials. The results of this study, in conjunction with results of prospective studies of trial participation, may be applied in future chemoprevention trials to facilitate recruitment, reduce attrition, and promote positive trial experiences for participants by emphasizing frequently reported benefits and minimizing frequently reported barriers.

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Cited by (20)

Prevention of head and neck squamous cell carcinoma: Removing the "chemo" from "chemoprevention"
2015, Oral Oncology
Citation Excerpt :
This reluctance is largely a result of perceived benefits and barriers of participation, reduced psychological well-being, absence of adequate counseling, and as well as possible lack of interest in participating in trials. In some cases the incurred cost in time and money and committing to a relatively lengthy intervention with a significant side effect profile play a major role [3–5]. Moreover, if the elevated cancer risk is related to life-style, adjusting risky habits may prove to be difficult for some and may also result in a lack of interest in trial participation.
The concept of chemoprevention whereby the use of a systemic agent is intended to halt the carcinogenesis process has been an attractive topic in head and neck squamous cell carcinoma (HNSCC). Yet, despite the significant efforts over the past decades and the substantial gain in knowledge of the biology of pre-malignant lesions of the head and neck, no tangible indications for chemoprevention have emerged for this disease. The negative results observed in the earlier larger studies using retinoids did not encourage further trials with these agents. Attention has been more recently focused on epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKIs) as well as cyclo-oxygenase 2 (COX-2) inhibitors with early studies showing encouraging responses but rather poor tolerance to therapy. Natural compounds have gained more interest recently given preclinical evidence of activity as well as a low side effect profile. We herein offer a comprehensive overview of the field of chemoprevention in HNSCC with an in depth analysis of the challenges we face and discuss a road map for future directions.
Patients' and physicians' perceptions on participation in a clinical trial: Results on a survey in a French hospital
2006, Therapie
Ce travail présente une première enquête conduite auprès de patients et d’investigateurs français, pour évaluer leurs motivations, les bénéfices et contraintes liées à leur participation à l’essai.
Vingt investigateurs et 37 patients ont été interrogés via un questionnaire.
La principale motivation du patient est l’altruisme contrairement à l’investigateur qui recherche prioritairement un bénéfice pour son patient. Après participation, le patient souligne sa satisfaction d’avoir pu aider la médecine. L’amélioration de son propre état de santé semble secondaire. Le risque principal lié à l’essai est celui d’être inclus dans le bras placebo. L’investigateur estime quant à lui avoir pu acquérir un savoir faire. Les contraintes sont essentiellement logistiques. Par ailleurs, il existe une divergence de perception d’un même essai entre le patient et l’investigateur, ce dernier surestimant généralement les contraintes de l’essai pour le patient.
La connaissance des ces éléments est utile pour améliorer le recrutement des patients qui s’avère encore difficile en France.
We report the first survey on French physicians and patients participating to assess motivations prior enrolment and benefits and constraints perceived after participation.
Twenty physicians were interviewed and 37 patients completed a questionnaire during clinical study participation.
If the main patient’s motivation is altruistic, physician wish their own patient feel better. After participation, patient is satisfied with being part of a research effort and contributing to medical science. Effect of trial treatment on physical well-being seems less pronounced. Main constraint is the randomisation to placebo group. For physicians, the main benefit is getting research experience and training. Main constraints are logistical. Otherwise, perceptions on the same clinical trial depend on participant. In fact, physician usually overestimates constraints of clinical trial for patient.
The knowledge of patients and physicians perceptions of clinical trials and its taking into account should probably reduce difficulties in the recruitment in France.
Perceptions of patients and physicians involved in clinical trials: An overview of the literature
2006, Therapie
L’objectif de ce travail bibliographique (base de données Medline, période 1966-2005) est de recenser les motivations des patients et des investigateurs, avant participation à un essai clinique et leurs perceptions, en cours ou après participation.
Sur 79 publications (3 françaises), 27 enquêtes anglo-saxonnes ont été menées auprès de patients et d’investigateurs. Leurs principales attentes sont respectivement l’altruisme et la recherche d’un bénéfice direct pour le patient. Après participation, si le patient souligne le réconfort psychologique reçu, l’investigateur est satisfait d’avoir fait accéder son patient à un nouveau traitement. L’investigateur évoque surtout des contraintes logistiques, tandis que le patient dénonce le principe de randomisation et l’inconfort lié aux multiples examens. Enfin, toutes les attentes de l’investigateur semblent satisfaites, contrairement à celles du patient.
La connaissance de la perception de l’essai clinique par ces acteurs est indispensable aux professionnels de santé, notamment pour améliorer le recrutemen.t
The purpose of this review is to explore the expectations of patients and physicians prior to participate to a clinical trial and their positive or negative experiences after participating. A systematic review of Medline database from 1966 to 2005 identified 79 papers reported patients and physicians perceptions of clinical trials (only 3 in French), whom 27 English surveys conducted on patients and physicians.
If primary patients’ motivation for enrolment was altruistic, physicians wish to help their patient. After enrolment, the most perceived positive benefit for patients and physicians are, respectively, the emotional improvement and the greater opportunity for personal benefit offered to enrolled patients. Most physicians’ negative experience included logistical difficulties while patients are unease with randomisation and often uncomfortable with medical procedures. Unlike patients, all physicians’ expectations seem to be fulfilled.
The knowledge of patients’ and physicians’ perception of participation may improve recruitment in clinical trials
Chemoprevention for colorectal cancer
2000, Critical Reviews in Oncology/Hematology
Altruism, personal benefit, and anxieties: a phenomenological study of healthy volunteers' experiences in a placebo-controlled trial of duloxetine
2016, Human Psychopharmacology
Random allocation or allocation at random? Patients’ perspectives of participation in a randomised controlled trial
2013, The Sociology of Health and Illness: A Reader

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Original articleParticipants' perceptions of a phase I colon cancer chemoprevention trial

Abstract

Prev Med.

Controlled Clin Trials

Controlled Clin Trials

Controlled Clin Trials

Controlled Clin Trials

Historical origins of the health belief model

Health Educ Monographs

Nonadherence to chemoprevention regimens: a ton of prevention

Adherence management in long-term clinical trials for prevention

J Nutr, Growth Cancer

Subject-reported compliance in a chemo-prevention trial for familial adenomatous polyposis

J Behav Med.

Participant enrollment, participation, and compliance in chemoprevention trials

Attitudes toward clinical trials among patients and the public

JAMA

Original article
Participants' perceptions of a phase I colon cancer chemoprevention trial