SPARC study; sexual rehabilitation after radiotherapy for gynaecological cancers

SUMMARY

Rationale: In the Netherlands, more than 4000 women are diagnosed with gynaecological cancers (GC) annually, of whom 30-40% receive primary or postoperative pelvic radiotherapy (RT), often combined with brachytherapy (RTBT). GC treatment and RT/RTBT in particular, is associated with high rates of sexual problems, such as pain during intercourse, and vaginal symptoms (dryness, shortening and/or tightening). In cooperation with the relevant professionals and patient advocates in the Netherlands, we developed a nurse-led sexual rehabilitation intervention to increase knowledge and coping strategies of patients (and their partners if available) regarding sexual issues after RT and benefits of and compliance with dilator use after RTBT. The intervention has been pilot-tested at two university medical centres (CME LUMC P13.102). Most patients reported that the intervention was helpful in resuming their sexual relationship. The nurses reported (after undergoing a specific 50 hour-training and receiving supervision of a psychologist/sexologist) that they had sufficient expertise to support the participants during sexual rehabilitation and vaginal dilator use. It was concluded that this intervention was feasible and applicable in clinical practice, and should be tested in a randomised controlled trial in a larger group of patients.

Objective: The primary aim is to evaluate if the nurse-led sexual rehabilitation intervention improves sexual recovery and functioning in GC patients after RT compared with usual care.
Study design: Women with GC (n=220) who receive RT in one of the participating GC centres (n=9) will be randomized to either the nurse-led sexual rehabilitation intervention or usual care, stratified for combined RTBT (n=110) vs. RT alone (n=110) and having a partner (yes/no). Participants are asked to complete questionnaires at baseline and 1, 3, 6, and 12 months after completion of RT.

Study population: Women who will be treated with RT for gynaecological cancer and who wish to retain their sexual activity on the short and/or long term.

Intervention (if applicable): The intervention consists of four one-hour sessions with the oncology nurse at 1 month, 3, 6, and 12 months after RT. Women who received RTBT will receive an additional appointment with the nurse (2 months after RTBT) to promote regular use of vaginal dilators in order to prevent stenosis. Oncology nurses conduct the intervention after a 50-hour training in sexology and cognitive behavioural interventions.

Main study parameters/endpoints: Primary endpoint is sexual functioning at 12 months post-RT and/or BT); secondary endpoints include: vaginal symptoms and body image concerns, fear of
(non-)coital sexual activity, treatment-related distress, psychological and sexual distress, generic-related health related to gynaecological cancer, relationship satisfaction, frequency of dilator use, and vaginal physical symptoms (assessed during physical examination by the radiation oncologist). The cost-effectiveness of the intervention will also be evaluated.

Given the high prevalence and burden associated with sexual problems and the existence of barriers to seek treatment among gynaecological cancer patients, there is a clear need for a brief, inexpensive and effective psychosexual rehabilitation intervention. We expect women who receive the nurse-led sexual rehabilitation programme to report a greater improvement in sexual functioning from immediate post-radiotherapy to 1 year post-radiotherapy than women in the control group.

The primary outcome (FSFI) will be assesed at baseline (before randomisation), 1, 3, 6, and 12 months post-RT(/RTBT).



The secondary outcome measures will be completed at 1, 3, 6, and 12 months after RT. The level of sexual distress (FSDS) is also assessed at baseline.



Physical examination will take place at baseline, and at 1, 3, 6 and 12 months after completion of treatment.



The questionnaire regarding the frequency of dilator use will be assessed at 1, 3, 6, and 12 months.

Intervention group: the nurse-led sexual rehabilitation programme will consist of four couple (or patient) sessions of a maximum of 60 minutes each, during the 12 months following RT. The sessions will be scheduled at 1 month, 3, 6- and 12 months after RT. Patients treated with RTBT will have an additional session at 2 months after RT. Furthermore, if preferred, patients and therapists can schedule one follow-up session/telephone consultation of 30 minutes between 6 and 12 months after RT. The nurse-led intervention will include (1) educating patients (and their partners) about the specific cancer diagnosis and treatment, (2) education on the importance of regular dilation for prevention of vaginal stenosis (if indicated), (3) discussing and resolving potential experienced barriers to perform new behaviour, such as dilation (if indicated) and lubricant use, and fear of penetration with dilators (if indicated) or fear of resuming sexual activity after cancer, (4) promoting couples’ mutual coping and support processes and (5) specific sexual therapy techniques to address sexual and body image concerns. Partners will be requested to participate in the sessions. The intervention offers a framework that allows individualization of treatment depending on patient-specific psychological, relational and somatic factors



Control group: Optimal 'care as usual'. Although ‘care as usual’ cannot be completely standardized, it will not involve a nurse-led intervention. This will slightly vary according to each participating hospital’s guidelines and the patients’ preference. However, since the Dutch guidelines suggest that information and dilators (if indicated) have to be recommended to all patients, and the information booklet ‘Sexuality after pelvic radiation for gynaecological cancer: Information for women and their partners’ has already been shown useful, all participants of the CAU condition will, as an optimal standard, be provided with the booklet, and a vaginal dilator set (if indicated), free of costs.



The patient information is also available on a website.