Stepped approach to improving sexual function after gynaecological cancer: the SAFFRON feasibility RCT.

BACKGROUND: Women affected by gynaecological cancer are often unaware of the sexual consequences of both the cancer and its treatment. Most do not receive appropriate advice or help to recover sexual function, and the effect on their sexuality may be profound, both physically and emotionally. However, several potential therapies can be effective in helping recover some sexual engagement and change self-perception around sex. A major initial challenge is informing and involving patients in an appropriate and sensitive manner, and a further issue is delivering therapies in busy gynaelogical oncology clinics. This study was conceived in response to a National Institute for Health Research (NIHR) Health Technology Assessment (HTA) call asking for proposals to improve sexual functioning in women treated for gynaecological cancer while taking into account associated issues of mood. Existing evidence-based therapies for improving sexual function after cancer treatment were adapted and placed within a 'stepped care' model for delivering these in the NHS setting. An assessment and treatment stepping algorithm was developed in parallel, both to assign women to a treatment level at assessment and to follow their progress session by session to advise on changing intervention level. The assessment tool was applied to all participants on the principle that the problem was sexual difficulty, not the cancer of origin.

PARTICIPANTS: Women aged > 18 years (with partners at their choice) treated for any gynaecological malignancy with surgery and/or chemotherapy and/or radiation at University College London Hospital or Bristol Gynaecological cancer centres, minimally 3 months post end of treatment, of any sexual orientation, with sexual function difficulties identified by three initial screening questions.

DESIGN: A feasibility two-arm, parallel-group randomised controlled pilot trial.

SETTING: Two NHS gynaecological cancer centres, one in London and one in Bristol.

INTERVENTIONS: A three-level stepped care intervention.

OBJECTIVE: To assess the feasibility of conducting a full-scale investigation of stepped therapy and indicate the potential benefits to patients and to the NHS generally.

PRIMARY OUTCOME MEASURES: Recruitment to study, proportion of women stepping up, number of usable data points of all measures and time points over length of trial, and retention of participants to end of trial.

RESULTS: Development of the intervention and accompanying algorithm was completed. The study was stopped before the recruitment stage and, hence, no randomisation, recruitment, numbers analysed, outcomes or harms were recorded.

LIMITATIONS: As the study did not proceed, the intervention and its accompanying algorithm have not been evaluated in practice, and the capacity of the NHS system to deliver it has not been examined.

CONCLUSIONS: None, as the study was halted.

FUTURE WORK: The intervention could be studied within a clinical setting; however, the experience of the study group points to the need for psychosocial studies in medical settings to establish pragmatic and innovative mechanisms to ensure adequate resource when extending staff clinical skills and time to deliver any new intervention for the duration of the trial.

TRIAL REGISTRATION: Current Controlled Trials ISRCTN12010952 and ClinicalTrials.gov NCT02458001.

FUNDING: This project was funded by the NIHR HTA programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 5. See the NIHR Journals Library website for further project information.