Why Cancer Patients Enter Randomized Clinical Trials: Exploring the Factors That Influence Their Decision

Wright, James R.; Whelan, Timothy J.; Schiff, Susan; Dubois, Sacha; Crooks, Dauna; Haines, Patricia; DeRosa, D; Roberts, Robin S.; Gafni, Amiram; Pritchard, Kathleen I.; Levine, Mark

doi:10.1200/jco.2004.01.187

Cited by 126 publications

(114 citation statements)

References 27 publications

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“…Making inclusion more explicit could aid in overcoming the cancer specialist's hesitation in offering a trial. This approach will need to be suppletrun -1mented with a sustained effort by the research community to educate physicians on the need for and the possibility of enrolling older patients in clinical trials [18][19][20][21].…”

Section: Discussionmentioning

confidence: 99%

“…However, a study on the attitudes of older patients toward enrolment in clinical trials demonstrates that, despite initial hesitation due to randomization, more than 75% of patients were willing to participate after additional explanation of the trial process [18]. Another study demonstrated that the amount of time spent with the patient (by the treating physician or a clinical research assistant) was identified as an import factor associated with the likelihood of participation of older patients in clinical trials [19]. When designing clinical trials, allocating sufficient time to endorse and explain the trial could significantly contribute to successfully recruiting greater numbers of older patients.…”

Section: Discussionmentioning

confidence: 99%

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Exclusion of Older Patients From Ongoing Clinical Trials for Hematological Malignancies: An Evaluation of the National Institutes of Health Clinical Trial Registry

2014

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Introduction. Cancer societies, research cooperatives, and countless publications have urged the development of clinical trials that facilitate the inclusion of older patients and those with comorbidities. We set out to determine the characteristics of currently recruiting clinical trials with hematological patients to assess their inclusion and exclusion of elderly patients. Methods. The NIH clinical trial registry was searched on July 1, 2013, for currently recruiting phase I, II or III clinical trials with hematological malignancies. Trial characteristics and study objectives were extracted from the registry website. Results. Although 5% of 1,207 included trials focused exclusively on elderly or unfit patients, 69% explicitly or implicitly excluded older patients. Exclusion based on age was seen in 27% of trials, exclusion based on performance status was seen in 16%, and exclusion based on stringent organ function

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Exclusion of Older Patients From Ongoing Clinical Trials for Hematological Malignancies: An Evaluation of the National Institutes of Health Clinical Trial Registry

2014

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“…This is a unique group of patients who have usually received several lines of previous treatments, have a short life expectancy,4 and have few remaining conventional treatment options. Entry into a phase 1 study requires the judgment of the relative likelihood of benefit versus toxicity and is essentially an individual patient's decision 5, 6. This encompasses a patient's motivations, expectations, and ability to comprehend the complexities of clinical trial research 7, 8.…”

Section: Introductionmentioning

confidence: 99%

A study of motivations and expectations of patients seen in phase 1 oncology clinics

Dolly

Kalaitzaki

Puglisi

et al. 2016

Cancer

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BACKGROUNDTo better inform clinical practice, this study was aimed at capturing patients' motivations for enrolling in phase 1 trials and at quantifying their expectations of the benefits, risks, and commitment associated with clinical trials and the impact of the initial consultation on their expectations.METHODSThis was a single‐center, prospective, quantitative study of newly referred adult patients considering their first phase 1 oncology trial. Participants completed questionnaires before they were seen and an abbreviated follow‐up version after their consultation.RESULTSQuestionnaires were completed by 396 (99%) and 301 (76%) before and after the clinic, respectively. Participants ranked the possibility of tumor shrinkage (84%) as the most important motivation for considering a phase 1 trial; this was followed by no alternative treatments (56%), their physician's recommendation (44%), and the fact that the research might benefit others (38%). When they were asked about the potential personal benefit, 43% predicted tumor shrinkage initially. After the consultation, this increased to 47%. Fourteen percent of patients expected a cure. When asked about risks, 71% of the participants expected moderate side effects. When asked about expectations of time commitments, a majority of patients did not anticipate weekly visits, although this was understood by 93% of patients after the consultation. Overall, patients were keen to consider trials and when asked before and after the consultation 72% and 84% were willing to enroll in studies, respectively.CONCLUSIONSThis study reports that more than 80% of patients enroll in early‐phase clinical oncology trials motivated by the potential of a clinical benefit, with approximately half expecting tumor shrinkage and approximately a tenth anticipating a cure. The typical phase 1 response rate is 4% to 20%, and this discrepancy exemplifies the challenges faced by patients and healthcare professionals during their interactions for phase 1 studies. Cancer 2016;122:3501–3508. © 2016 American Cancer Society

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“…12,13 Patients were also more likely to enter a trial when their physicians believed that the study was asking an important question. 12 Financial issues may also be an important factor. Clinical research in the US is currently supported largely by the pharmaceutical industry.…”

Section: Discussionmentioning

confidence: 99%

Randomized clinical trials for hematopoietic stem cell transplantation: lessons to be learned from the European experience

Kuthiala

Lyman

Ballester

2005

Bone Marrow Transplant

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We evaluated the number and characteristics of randomized controlled trials (RCTs) addressing hematopoietic stem cell transplantation (HSCT) for patients with hematological malignancies, comparing the productivity of US and Europe. A MEDLINE search was conducted to identify all published RCTs for the management of adult patients with hematological malignancies from January 1992 to December 2003. Eighty-three of the 306 trials identified included HSCT as one of the treatment arms. The US produced 25, Europe 54, and all other countries four. Four European countries, France, Italy, Germany, and UK (FIGU), produced 32 out of the 54 European studies. Significant differences emerged when focus of the study and accrual numbers were analyzed. Trials comparing HSCT to standard dose therapy represented 34.9% of the 83 trials and 59.4% of FIGU trials, but only 4% of US studies (P ¼ 0.001). US trials accrued a mean of 110.2 patients per study, as compared to 222.6 in FIGU studies (P ¼ 0.006) and 205.3 when all non-US countries are considered (P ¼ 0.01). Our conclusions are that US transplant RCT have focused on issues other than the comparison of HSCT to standard therapies. There is serious paucity of US trials defining the role of HSCT in the management of hematological malignancies.

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Why Cancer Patients Enter Randomized Clinical Trials: Exploring the Factors That Influence Their Decision

Cited by 126 publications

References 27 publications

Exclusion of Older Patients From Ongoing Clinical Trials for Hematological Malignancies: An Evaluation of the National Institutes of Health Clinical Trial Registry

Exclusion of Older Patients From Ongoing Clinical Trials for Hematological Malignancies: An Evaluation of the National Institutes of Health Clinical Trial Registry

A study of motivations and expectations of patients seen in phase 1 oncology clinics

Randomized clinical trials for hematopoietic stem cell transplantation: lessons to be learned from the European experience

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