Objective: To assess the feasibility and acceptability of including sexual activity questionnaires in gynaecological clinical trials.
Design: A longitudinal quality of life study during the Maintenance Interferon Trial and the EVALUATE Hysterectomy Trial.
Setting: Gynaecology clinics and women's homes.
Sample: Ninety-six women with advanced ovarian cancer participating in the Maintenance Interferon Trial and 542 women undergoing a hysterectomy in the EVALUATE Hysterectomy Trial.
Methods: Quality of life questionnaires, including the sexual activity questionnaire, were completed by women prior to randomisation and periodically after randomisation.
Main outcome measures: Compliance rates of the sexual activity questionnaire, both overall and with respect to the level of sexual functioning and age of the women. Attitudes of the women towards completing the questionnaire, and suitability of using the sexual activity questionnaire in clinical trials.
Results: Compliance rates of over 80% were achieved in both trials, both overall and for each questionnaire completed. The age of the woman did not appear to influence the completion of the questionnaire, nor did her level of sexual functioning. Women were supportive of the research and did not find the questionnaire intrusive.
Conclusions: It is feasible to include sexual activity questionnaires in gynaecological clinical trials requiring repeated assessment of quality of life over a long period of time. The sexual activity questionnaire is an appropriate tool to carry out investigations of sexual functioning and is worth considering for use in future clinical trials.