Efficacy of a nurse-led sexual rehabilitation intervention for women with gynaecological cancers receiving radiotherapy: results of a randomised trial

Abstract

Background: The multicentre randomised SPARC trial evaluated the efficacy of a nurse-led sexual rehabilitation intervention on sexual functioning, distress, dilator use, and vaginal symptoms after radiotherapy for gynaecological cancers.

Methods: Eligible women were randomised to the rehabilitation intervention or care-as-usual. Four intervention sessions were scheduled over 12 months, with concurrent validated questionnaires and clinical assessments. Primary outcome was the Female Sexual Function Index (FSFI). A generalised-mixed-effects model compared groups over time.

Results: In total, 229 women were included (n = 112 intervention; n = 117 care-as-usual). No differences in FSFI total scores were found between groups at any timepoint (P = 0.37), with 12-month scores of 22.57 (intervention) versus 21.76 (care-as-usual). The intervention did not significantly improve dilator use, reduce sexual distress or vaginal symptoms compared to care-as-usual. At 12 months, both groups had minimal physician-reported vaginal stenosis; 70% of women were sexually active and reported no or mild vaginal symptoms. After radiotherapy and brachytherapy, 85% (intervention) versus 75% (care-as-usual) of participants reported dilation twice weekly.

Discussion: Sexual rehabilitation for women treated with combined (chemo)radiotherapy and brachytherapy improved before and during the SPARC trial, which likely contributed to comparable study groups. Best practice involves a sexual rehabilitation appointment 1 month post-radiotherapy, including patient information, with dilator guidance, preferably by a trained nurse, and follow-up during the first year after treatment.

Clinical trial registration: NCT03611517.

Fig. 1. CONSORT diagram.

N = total number of patients invited for the study, n = subgroup of patients, RT = radiotherapy. *One patient was initially stratified for external beam radiotherapy combined with brachytherapy but ultimately received external beam radiotherapy alone. Consequently, her rehabilitation trajectory was according to external beam radiotherapy alone; therefore she was moved to external beam radiotherapy alone. ^xOne patient was initially stratified for external beam radiotherapy alone, however she received an additional external beam radiotherapy boost. This led to modification in her rehabilitation trajectory to align external beam radiotherapy combined with brachytherapy; therefore she was moved to external beam radiotherapy combined with brachytherapy.

Fig. 2. Patient-reported average scores on sexual functioning and sexual distress.

BM baseline measurement, CAU Care-as-usual group, FSDS Female Sexual Distress Scale (higher score is more sexual distress), FSFI Female Sexual Function Index (higher score is better sexual functioning), INT Intervention group, M months, N = observed number of women at the specific timepoint.

Fig. 3. Physician-reported clinical measurements and patient-reported vaginal functioning problems (of sexually active women in the past 4 weeks) on a single-item level over time.

The proportion of women is shown in percentages. BM baseline measurement, CTCAE Common Terminology Criteria for Adverse Events, EORTC QLQ-CX24 European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gynaecological Cancer Module, M months, N = number of women at risk at the specific timepoint, n = number of sexually active women at risk at the specific timepoint according to EORTC QLQ-CX24 item 19, O = observed number of women at the specific timepoint.

Fig. 4. Patient-reported dilation in the past 4 weeks over time.

The proportion of women is shown in percentages. M months, mo month, N = number of women at risk who received dilators, O = observed number of women at the specific timepoint, wk week.