title: Recruitment and early retention of women with advanced breast cancer in a complementary and alternative medicine trial.
abstract: More than 80% of women with breast cancer are now reported to be using complementary and alternative medicine (CAM) therapies during conventional treatment. A randomized clinical trial (RCT) of reflexology with late stage breast cancer patients serves as the data source for this article. The purposes were to investigate: (i) reasons for refusal to participate in a RCT of reflexology; (ii) the differences between those who completed the baseline interview and those who dropped out before baseline; and (iii) the utility of the Palliative Prognostic Score (PPS) as a prognostic screening tool in minimizing early attrition (before baseline) from the trial. Eligible women (N = 400) approached at 12 cancer centers in the Midwest had advanced breast cancer, were on chemotherapy or hormonal therapy, and had a PPS of 11 or less. Comparisons of those who dropped out early (N = 33) to those who stayed in the trial (N = 240) were carried out using Wilcoxon rank, t-, chi-squared and Fisher's exact tests. The reasons of being "too sick" or "overwhelmed" were given by less than 12% of the women who refused to participate. There was a higher early dropout rate among black women compared to other (primarily white) women (P = .01). Cancer recurrence and metastasis, age, and the PPS were not predictive of early retention of women. Specialized techniques may be needed to ensure black women remain in the trial once consented. Women with advanced disease were likely to enter and remain in the trial despite deterioration in health.
authors.affiliation: Department of Statistics and Probability, College of Natural Science, Michigan State University, East Lansing, MI 48824, USA.
authors.forename: Alla
authors.initials: A
authors.lastname: Sikorskii
authors.forename: Gwen K
authors.initials: GK
authors.lastname: Wyatt
authors.forename: Azfar-E-Alam
authors.initials: AE
authors.lastname: Siddiqi
authors.forename: Deimante
authors.initials: D
authors.lastname: Tamkus