Patient Participation and Compliance in Cancer Chemoprevention Trials: Issues and Concerns

Abstract

Cancer chemoprevention trials have unique characteristics that make the tasks of participant recruitment, enrollment, and long-term adherence to the study protocol and intervention regimen especially difficult. Barriers to patient accrual, long-term participation, and optimal adherence are inherent in clinical trial design and organization, and are frequently associated with the attitudes and behavioral dynamics of physicians and the participants themselves. Attracting racially and ethnically diverse populations to trial participation adds additional problems and considerations. Careful planning early in the design phase of a chemoprevention clinical trial must take into account these numerous issues. Clinical investigators should seek expert advice from a number of health care disciplines to better design chemoprevention protocols that minimize logistic complexity, maximize participant eligibility, simplify data collection, and take into account the complex behavioral dynamics of the clinical trial process.

Recruiting Low-Income Healthy Women to Research: An Exploratory Study

“…Some recent large chemoprevention trials (Moinpour et al 2000;Ford et al 2003a;Higgins & Thompson 2004;Lippman et al 2005) have failed to recruit minorities in adequate numbers, or were somewhat successful but only with great effort and at considerable cost Lippman et al 2005). In addition to individual barriers, such as patient desire for control over medical decisions, fear of risks, loss of privacy and lack of family support, many of the barriers noted for recruitment of healthy participants are structural and access issues that may reflect institutional racism, such as: complex trial design, primary care provider reluctance; transportation and costs associated with participation; and characteristics of the health care system (Tangrea 1997;Kinney et al 1998;Ruffin & Baron 2000;Frayne et al 2001;Ford et al 2003a). For breast cancer prevention trials, bias in the GAIL model (a risk assessment tool for general breast cancer risk screening) (Gail 1992) for assessing genetically-based breast cancer risk reduced the eligibility of ethnic/racial minorities according to one recent study (Grann et al 2005).…”

“…For breast cancer prevention trials, bias in the GAIL model (a risk assessment tool for general breast cancer risk screening) (Gail 1992) for assessing genetically-based breast cancer risk reduced the eligibility of ethnic/racial minorities according to one recent study (Grann et al 2005). Younger age and higher socioeconomic, education, and occupational status, as well as prior experience with a clinical study have been shown to increase the likelihood of participation in chemoprevention and other prevention studies (Tangrea 1997;Zhu et al 2000).…”

How Should We Inform Women at Higher Risk of Breast Cancer About Tamoxifen? An Approach with a Decision Guide

“…When given hypothetical scenarios, healthy people were less likely than cancer patients to trade the side effects of toxic chemotherapy for small gains in survival [5,6]. Low rates of tamoxifen acceptance in some studies may be explained because this healthy population may be less willing to accept even mild toxic effects and to incur the logistic and economic inconveniences of treatment than patients being treated for an established cancer [20,21].…”

Molecular Markers of Estrogen Metabolism and Progression From High-Grade Prostatic Intraepithelial Neoplasia (HGPIN) to Prostate Cancer

“…Both CYPIBI and CYP3A4 are expressed in prostate tissue, a polymorphism of the CYP3A4 gene in tiie 5' transcriptional regulatory element (CYP3A4-V) has been significantly associated with later age and advanced stage at CaP detection compared to men with the wild-type gene (6). Similarly, prostate cancer cases may be 3-fold more likely than controls to be homozygous for the CYPIBI ^''' allele (7). The goal of this New Investigator Award is to conduct a pilot case-control study investigating the association between molecular markers of estrogen metabolism and diagnosis of prostate cancer (stage WJH) and high-grade prostatic intraepithelial neoplasia (HGPIN), the purported precursor pathologic state to prostate cancer.…”