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eCAM Advance Access published online on July 20, 2009
eCAM, doi:10.1093/ecam/nep051
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© 2009 The Author(s).
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/2.0/uk/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Recruitment and Early Retention of Women with Advanced Breast Cancer in a Complementary and Alternative Medicine Trial

Alla Sikorskii1, Gwen K. Wyatt2, Azfar-e-Alam Siddiqi3 and Deimante Tamkus3

1Department of Statistics and Probability, College of Natural Science, 2College of Nursing and 3College of Human Medicine Michigan State University, East Lansing, MI 48824, USA

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 = 0.01). 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.

Keywords: cancer – complementary and alternative medicine – clinical trail – attrition

For reprints and all correspondence: Gwen K. Wyatt, College of Nursing, B515E West Fee Hall, Michigan State University, East Lansing, MI 488424, USA. Tel: +1-517-432-5511; Fax: +1-517-353-4587; E-mail: gwyatt{at}msu.edu

Received December 18, 2008; accepted May 7, 2009


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