Psychological and clinical factors implicated in decision making about a trial of low-dose tamoxifen in hormone replacement therapy users.
OBJECTIVE
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.


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 > or = 60 years (OR = 0.40; 95% CI, 0.22 to 0.73).


CONCLUSIONS
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.
Rondanina
Gabriella
G
Medical Oncology Unit, Galliera Hospital, Genoa, Italy.
Puntoni
Matteo
M
Severi
Gianluca
G
Varricchio
Clara
C
Zunino
Anna
A
Feroce
Irene
I
Bonanni
Bernardo
B
Decensi
Andrea
A
D000367:Age Factors; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D001007:Anxiety; D001943:Breast Neoplasms / Q000517:prevention & control* / Q000523:psychology; D002986:Clinical Trials as Topic / Q000523:psychology*; D003376:Counseling; D003657:Decision Making; D003863:Depression; D020847:Estrogen Receptor Modulators / Q000627:therapeutic use*; D015914:Estrogen Replacement Therapy; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006304:Health Status; D006801:Humans; D008019:Life Style; D016015:Logistic Models; D008875:Middle Aged; D015999:Multivariate Analysis; D016017:Odds Ratio; D017060:Patient Satisfaction; D010817:Physician-Patient Relations; D012307:Risk Factors; D012959:Socioeconomic Factors; D013629:Tamoxifen / Q000627:therapeutic use*
D018931:Antineoplastic Agents, Hormonal; D020847:Estrogen Receptor Modulators; D013629:Tamoxifen