Article Text
Abstract
Introduction/Background Primary treatment for women with locally advanced gynaecological cancers involves radio(chemo)therapy and MRI-guided adaptive brachytherapy (EBRT+BT), while those with early-stage disease receive postoperative radiotherapy for risk factors. This significantly impacts vaginal symptoms and sexual functioning. A pilot study of a nurse-led rehabilitation intervention suggested improved sexual functioning after radiotherapy. The SPARC randomised trial compared the intervention with care-as-usual in improving sexual functioning, sexual distress, dilator adherence, and vaginal symptoms.
Methodology 229 women were randomised to intervention or care-as-usual. Specifically trained nurses conducted the rehabilitation sessions at 1, 3, 6 and 12-months after radiotherapy, and additionally at 2-months for women who received EBRT+BT. Concurrently, validated questionnaires and clinical assessments were completed; the Female Sexual Function Index (FSFI) was the primary outcome. A generalized mixed effects multilevel model compared the groups over time.
Results Both groups experienced decreased sexual functioning after treatment, gradually improving over the first year. No significant differences in FSFI total-scores were found over time (p=0.52), with 12-month FSFI-scores of 22.53 (intervention) vs. 21.76 (care-as-usual, see figure 1). The intervention did not significantly improve dilator compliance, sexual distress or vaginal symptoms. At 12-months, most women had no (65%) or mild (23%) vaginal stenosis, and 70% reported sexual activity. Most reported little (33%) or no (55%) vaginal shortness, dryness and pain during intercourse. Among women who received EBRT+BT, 80% reported dilation (dilators, vibrators, dildos, fingers, and/or intercourse) at least twice weekly.
Conclusion Similar levels of sexual functioning and distress, high rates of sexual activity and dilator compliance, and mild vaginal symptoms were found in both arms. Quality of sexual rehabilitation care-as-usual improved significantly during the SPARC trial. Best clinical practice comprises comprehensive patient information, at least one dedicated appointment one-month after radiotherapy with explicit dilator guidance, preferably by a specially trained nurse, and dedicated follow-up throughout the first year after treatment.
Disclosures The SPARC study was supported by a grant from the Dutch Cancer Society, Alpe d’HuZes fund (grant number 10674).