Factors Influencing Enrollment in Clinical Trials for Cancer Treatment

Cn, Klabunde; Bc, Springer; Butler, Beth; Ms, White; Atkins, Johnique T.

doi:10.1097/00007611-199912000-00011

Cited by 92 publications

(91 citation statements)

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“…The study was designed with an assumed clinical trial refusal rate of 40% which was based on an average from previous studies (Klabunde et al, 1999;Jenkins and Fallowfield, 2000;Lara et al, 2001). However, the observed refusal rate for clinical trials in this study of approximately 20% is substantially less than that reported in the literature.…”

Section: Discussionmentioning

confidence: 88%

“…Compared with earlier phase studies (Gordon and Daugherty, 2001), relatively high rates of patient refusal have been reported: 28% (Jenkins and Fallowfield, 2000), 40% (Klabunde et al, 1999) and 49% (Lara et al, 2001). Research undertaken in 'hypothetical trial' situations of chemotherapy have shown refusal rates of 40% (Sutherland et al, 1990) and 58% (Llewellyn- Thomas et al, 1991).…”

Section: Clinical Trials and Recruitmentmentioning

confidence: 86%

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A randomised controlled study of an audiovisual patient information intervention on informed consent and recruitment to cancer clinical trials

et al. 2007

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Recruitment to cancer clinical trials needs to be improved, as does patient knowledge and understanding about clinical trials, in order for patients to make an informed choice about whether or not to take part. Audiovisual patient information (AVPI) has been shown to improve knowledge and understanding in various areas of practice, but there is limited information about its effect in the cancer clinical trial setting, particularly in relation to consent rates. In this study, 173 patients were randomised to receive either the AVPI, in addition to the standard trial-specific written information, or the written information alone. There was no difference in clinical trial recruitment rates between the two groups with similar study entry rates: 72.1% in the AVPI group and 75.9% in the standard information group. The estimated odds ratio for refusal (intervention/no intervention) was 1.19 (95% CI 0.55 -2.58, P ¼ 0.661). Knowledge scores increased more in the AVPI group compared to the standard group (P ¼ 0.0072). The change in anxiety score between the arms was also statistically significant (P ¼ 0.011) with anxiety improving in the intervention arm more than in the no intervention arm. Audiovisual patient information was shown to be a useful tool in improving patient knowledge and anxiety, but further work is necessary in relation to its effect on clinical trial recruitment rates.

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Section: Discussionmentioning

confidence: 88%

Section: Clinical Trials and Recruitmentmentioning

confidence: 86%

A randomised controlled study of an audiovisual patient information intervention on informed consent and recruitment to cancer clinical trials

et al. 2007

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“…In the United States, for adult patients, a mere 2 to 7% of cancer patients are enrolled in National Cancer Institute sponsored trials (19,20), while our enrollment for adults was 30%. There was declining enrollment with time, however.…”

Section: Discussionmentioning

confidence: 99%

Captopril to Mitigate Chronic Renal Failure After Hematopoietic Stem Cell Transplantation: A Randomized Controlled Trial

Cohen¹,

Irving²,

Drobyski³

et al. 2008

International Journal of Radiation Oncology*Biology*Physics

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SummaryPurpose-Chronic renal failure is an acknowledged complication of hematopoietic stem cell transplantation (HSCT) in humans. It can be caused in part by radiation injury when HSCT is preceded by sufficient total body irradiation (TBI). Studies in laboratory animals show the benefit of angiotensin converting enzyme (ACE) inhibitors in mitigation and treatment of this complication. We thus conducted a randomized controlled trial testing whether the ACE inhibitor captopril was effective in mitigating chronic renal failure after HSCT.Methods and materials-55 subjects undergoing TBI-HSCT were enrolled. Captopril, or identical placebo, was started at engraftment, and continued as tolerated until one year after HSCT.Results-The baseline serum creatinine and calculated glomerular filtration rate (GFR) did not differ between groups. The one-year serum creatinine was lower, and the GFR higher, in the captopril compared to the placebo group ( p=0.07, for GFR). Patient survival was higher in the captopril compared to the placebo group, but this was also not statistically significant (p=0.09). In study subjects who were on study drug for more than two months, the one-year calculated GFRs were 92 ml/min and 80 ml/min, for the captopril and placebo groups, respectively (p=0.1). There was no adverse effect on hematological outcome.Conclusion-We conclude that there is a trend in favor of captopril in mitigation of chronic renal failure after radiation-based HSCT.

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“…The fraction of eligible patients recruited to clinical trials have decreased worldwide in recent years [1,2], postponing trial completion and rendering the projective universality of trial results unpredictable [3Á 5]. This development can only partly be explained by physician/system/societal factors [3,5 Á13].…”

mentioning

confidence: 99%

Participating in a cancer clinical trial? The balancing of options in the loneliness of autonomy: A grounded theory interview study

2007

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Factors Influencing Enrollment in Clinical Trials for Cancer Treatment

Cited by 92 publications

References 0 publications

A randomised controlled study of an audiovisual patient information intervention on informed consent and recruitment to cancer clinical trials

A randomised controlled study of an audiovisual patient information intervention on informed consent and recruitment to cancer clinical trials

Captopril to Mitigate Chronic Renal Failure After Hematopoietic Stem Cell Transplantation: A Randomized Controlled Trial

Participating in a cancer clinical trial? The balancing of options in the loneliness of autonomy: A grounded theory interview study

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