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Psychological and Clinical Factors Implicated in Decision Making About a Trial of Low-Dose Tamoxifen in Hormone Replacement Therapy Users

Gabriella Rondanina, Matteo Puntoni, Gianluca Severi, Clara Varricchio, Anna Zunino, Irene Feroce, Bernardo Bonanni, Andrea Decensi

From the Medical Oncology Unit, Galliera Hospital; Biostatistics Unit, Department of Health Sciences; Health Psychology Unit, Department of Educational Sciences, University of Genoa, Genoa; Prevention and Cancer Genetics Unit, European Institute of Oncology, Milan, Italy; and Cancer Epidemiology Center, The Cancer Council Victoria, Melbourne, Victoria, Australia

Corresponding author: Andrea Decensi, MD, Division of Medical Oncology, E.O. Ospedali Galliera, Mura delle Cappuccine 14, 16128 Genoa, Italy; e-mail: andrea.decensi{at}galliera.it

Purpose: To assess the sociodemographic, health-related, and psychological factors that influence the decision of women on hormone replacement therapy (HRT) to participate in a phase III trial of low-dose tamoxifen.

Patients and Methods: Clinical and psychological factors were assessed in 265 women who accepted and 192 women who refused to participate in a proposed trial. Health-related and sociodemographic factors included age, Gail risk, body mass index, education, current HRT use, regular mammographic screening, smoking habit, physical activity, alcohol use, concern about adverse effects, and physician recommendation. Psychological factors included breast cancer–related worry, absolute and comparative cancer risk perception, anxiety, and depression.

Results: The most frequent reasons for entry were willingness to participate in a research program (60%), the need/desire to receive frequent medical care (58%), and the desire to contribute to medical knowledge (44%); whereas reasons for refusal included fear of medication abuse (33%), concern about adverse effects (31%), and physician advice against enrollment (24%). In a logistic model, after adjusting for current HRT use, the trial participation was directly associated with satisfaction with clearly explained study objectives (odds ratio [OR] = 9.33; 95% CI, 4.04 to 21.55) and inversely associated with high breast cancer worry (OR = 0.15; 95% CI, 0.03 to 0.77) and age 60 years (OR = 0.40; 95% CI, 0.22 to 0.73).

Conclusion: Participation in a chemoprevention trial among HRT users is associated with a younger age, no breast cancer worry, and satisfaction with health care providers, suggesting a condition of psychological well-being as a promoting factor and emphasizing the importance of thorough counseling at study presentation.

Supported by Grant No. BCTR01-00537 from the S. Komen Breast Cancer Foundation, a grant from the Italian Health Ministry (Ricerca Finalizzata), a fellowship from Gruppo Bancario Credito Valtellinese and the European School of Oncology, and a contract from the Italian Foundation for Cancer Research.

Presented in part at the 4th Annual American Association for Cancer Research Conference Frontiers in Cancer Prevention Research, November 11-15, 2006, Boston, MA.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.