Factors and Outcomes of Decision Making for Cancer Clinical Trial Participation

Biedrzycki, Barbara

doi:10.1188/11.onf.542-552

Cited by 18 publications

(19 citation statements)

References 38 publications

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“…Physician recommendation of clinical trials is known to increase trial enrollment 9,10 and most patients prefer a collaborative approach between physician and patient for clinical trial decision- making. 11 Wallace et al successfully increased accrual to a difficult-to-recruit-for clinical trial after adding a multidisciplinary education session presented by a urologist and radiation oncologist as part of the recruitment process. 12 …”

Section: Discussionmentioning

confidence: 99%

Impact of a Clinical Trial Initiative on Clinical Trial Enrollment in a Multidisciplinary Prostate Cancer Clinic

Madsen¹,

Kuban²,

Choi³

et al. 2014

J Natl Compr Canc Netw

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Purpose Clinical oncology trials are hampered by low accrual rates with less than 5% of adult cancer patients treated on study. We evaluated clinical trial enrollment in our Multidisciplinary Prostate Cancer Clinic (MPCC) to assess if a clinical trial initiative, introduced in 2006, impacted enrollment. Methods The trial initiative included posting trial specific information in clinic, educating patients about appropriate clinical trial options during the treatment recommendation discussion, and providing patients with trial specific educational information. We evaluated frequency of clinical trial enrollment for men with newly-diagnosed prostate cancer seen in the MPCC from 2004 to 2008. Logistic regression evaluated the impact of patient characteristics and the clinical trial initiative on trial enrollment. Results The median age of the 1,370 men was 64 years. 32% had low-risk, 49% had intermediate-risk and 19% had high-risk disease. Overall, 74% enrolled in at least one trial and 29% enrolled in more than one trial. Trial enrollment increased from 39% before the initiative (127/326) to 84% (880/1044) after the trial initiative. Patient enrollment increased in laboratory studies (25% to 80%), quality-of-life studies (10% to 26%) and studies evaluating investigational treatments and systemic agents (6% to 15%) after the trial initiative. In multivariate analysis, younger men (p<0.001) and men seen after implementation of the clinical trial initiative (p<0.001) were more likely to enroll in trials. Conclusion Clinical trial enrollment in our Multidisciplinary Prostate Cancer Clinic was substantially higher than seen nationally in adult cancer patients and enrollment rates increased after introduction of a clinical trial initiative.

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Section: Discussionmentioning

confidence: 99%

Impact of a Clinical Trial Initiative on Clinical Trial Enrollment in a Multidisciplinary Prostate Cancer Clinic

Madsen¹,

Kuban²,

Choi³

et al. 2014

J Natl Compr Canc Netw

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“…Demographic variables are reported as influencing patients' decision-making as education, financial status, severity of the disease and ability to communicate (Verheggen et al 1998;Ellis et al 2001;Biedrzycki 2011).…”

Section: Introductionmentioning

confidence: 99%

Hope for a cure and altruism are the main motives behind participation in phase 3 clinical cancer trials

Godskesen

Hansson²,

Nygren

et al. 2014

Eur J Cancer Care (Engl)

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It is necessary to carry out randomised clinical cancer trials (RCTs) in order to evaluate new, potentially useful treatments for future cancer patients. Participation in clinical trials plays an important role in determining whether a new treatment is the best therapy or not. Therefore, it is important to understand on what basis patients decide to participate in clinical trials and to investigate the implications of this understanding for optimising the information process related to study participation. The aims of this study were to (1) describe motives associated with participation in RCTs, (2) assess if patients comprehend the information related to trial enrolment, and (3) describe patient experiences of trial participation. Questionnaires were sent to 96 cancer patients participating in one of nine ongoing clinical phase 3 trials at the Department of Oncology, Uppsala University Hospital in Sweden. Eighty-eight patients completed the questionnaire (response rate 92%); 95% of these were patients in adjuvant therapy and 5% participated in clinical trials on palliative care. Two main reasons for participation were identified: personal hope for a cure and altruism. Patients show adequate understanding of the information provided to them in the consent process and participation entails high patient satisfaction.

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“…Discussion of trials between the treating physician and the patient is most often in the physician domain to initiate [29-31], though more and more frequently patients raise the possibility with their doctors, the patient domain [32,33], and this is increasingly recognized as physician-patient partnership [34,35]. Discussion of trials occurs to ascertain whether a patient is able to understand the nature of the clinical trial [36,37] and its benefits and costs, and to assess the patient’s ability to provide informed consent [38].…”

Section: Methodsmentioning

confidence: 99%

“…Patient consent is a domain stage of clinical trial accrual and is linked closely to respect for patient autonomy [34,44]. Issues related to prostate cancer participation in clinical trials that facilitate consent include patient preferences for specific interventions [45], lower socioeconomic status [46], cost of travel and friends/family to accompany the patient [43,47], availability of the intervention outside a trial setting [48], and an intervention that ‘kills cancer cells’ [49].…”

Section: Methodsmentioning

confidence: 99%

Removing barriers to participation in clinical trials, a conceptual framework and retrospective chart review study

Kanarek

Olatoye³

et al. 2012

Trials

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BackgroundEnrollment in interventional therapeutic clinical trials is a small fraction of all patients who might participate given reasonable access.MethodsA hierarchical approach is utilized in measuring staged participation from trial availability to patient enrollment. Our framework suggests that concern for justice comes in the design and eligibility criteria for clinical trials; attention to beneficence is given in the eligibility and physician triage stages. The remaining four stages rely on respect for persons. An example is given where reasons for nonparticipation or barriers to participation in prostate cancer clinical trials are examined within the framework. In addition, medical oncology patients with an initial six month consultation are tracked from one stage to the next by race using the framework to assess participation comparability.ResultsWe illustrated seven transitions from being a patient to enrollment in a clinical trial in a small study of prostate cancer cases who consulted SKCCC Medical Oncology Department in early 2010. Pilot data suggest transition probabilities as follows: 65% availability, 84% eligibility, 92% patient triage, 89% trials discussed, 45% patient interested, 63% patient consented, and 92% patient enrolled. The average transition probability was 77.7%. The average transition probability, patient-trial-fit was 50%; opportunity was 51%, and acceptance was 66.7%. Trial availability, patient interest and patient consented were three transitions that were below the average; none were statistically significant.ConclusionsThe framework may serve to streamline comprehensive reporting of clinical trial participation to the benefit of patients and the ethical conduct of clinical trials.

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Factors and Outcomes of Decision Making for Cancer Clinical Trial Participation

Cited by 18 publications

References 38 publications

Impact of a Clinical Trial Initiative on Clinical Trial Enrollment in a Multidisciplinary Prostate Cancer Clinic

Impact of a Clinical Trial Initiative on Clinical Trial Enrollment in a Multidisciplinary Prostate Cancer Clinic

Hope for a cure and altruism are the main motives behind participation in phase 3 clinical cancer trials

Removing barriers to participation in clinical trials, a conceptual framework and retrospective chart review study

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