The development, pilot and randomised controlled trial of a psychosexual rehabilitation information booklet for women undergoing pelvic radiation therapy for gynaecological or anorectal cancer

Abstract

This research entailed the development, pilot and randomised controlled trial (RCT) of a psychosexual information booklet for women undergoing pelvic radiation therapy (PRT) for gynaecological or anorectal cancer. This was undertaken due to: the high prevalence of psychosexual morbidity following PRT, a paucity of research in women affected by anorectal cancer, and the lack of existing resources to facilitate rehabilitation and reduce distress in this area. The booklet was informed by the literature review, input from an expert multi-disciplinary advisory group, and published standards in developing information materials for cancer consumers. After the booklet development, a mainly qualitative retrospective pilot study explored women’s experiences and vaginal changes/psychosexual rehabilitation informational needs after PRT; the feasibility and acceptability of the booklet and the measurement protocol for a later RCT. The pilot highlighted many PRT-related adjustment challenges and unmet informational needs, particularly regarding sexual rehabilitation. Overall, the pilot findings provided support for the booklet provision to better support women in physical and psychosexual rehabilitation following PRT. A revised version of the booklet was prospectively evaluated in a multicentre RCT. The longitudinal RCT evaluated whether the booklet improved adherence to recommended rehabilitation strategies (vaginal dilator use, vaginal lubrication and pelvic floor muscle exercises), improved knowledge of rehabilitation strategies, lowered levels of anxiety, depression and PRT-related psychological distress and improved sexual activity, function and satisfaction post PRT. The RCT demonstrated that the booklet improved knowledge and vaginal dilator use at 3 and 6 months. Given the many patient-clinician and patient-related barriers inhibiting the use of vaginal dilators, this represents an important outcome and basis for further improvement of women’s psychosexual outcomes.