ESTRO 2024 - Abstract Book
S1013
Clinical - Gynaecology
ESTRO 2024
Primary treatment for locally advanced cervical and vaginal cancers with external beam radiotherapy, concurrent chemotherapy and MRI-guided adaptive brachytherapy is associated with profound impact on vaginal symptoms and sexual functioning. Women with early-stage gynaecological cancers undergoing surgery and adjuvant radiotherapy with or without brachytherapy boost may have similar sexual functioning problems. Regular vaginal dilation prevents vaginal stenosis. However, many women fail to use them regularly. A pilot study(1) of a dedicated nurse-led intervention was shown to improve sexual rehabilitation. In the randomised SPARC study (Sexual rehabilitation Programme After Radiotherapy for gynaecological Cancer) we assessed the efficacy of this intervention on sexual functioning, sexual distress, compliance with dilator use, and vaginal symptoms.
Material/Methods:
The SPARC study was a multicentre, randomised trial conducted in 10 gynaecological radiotherapy centres in The Netherlands (ClinicalTrials.gov number NCT03611517). Eligible women had cervical, vaginal, or endometrial cancer, were treated with primary or postoperative external beam radiotherapy with or without concurrent chemotherapy and brachytherapy; were 18 years or older, and intended to remain sexually active. They were randomly assigned to either the nurse-led rehabilitation intervention or care-as-usual. Oncology nurses or radiotherapy technicians completed a dedicated 5-day training before conducting the 4-session counselling programme in the intervention group. Sessions were at 1, 3, 6 and 12 months after treatment, with an additional session at 2 months for women who received brachytherapy. Validated questionnaires and clinical assessments were completed at the same timepoints, with primary outcome being the Female Sexual Function Index (FSFI). A generalized mixed effects multilevel model was used to compare the groups over time. Between August 2018 and January 2022, 229 women were enrolled, of whom 36 (16%) discontinued participation before the 12-month assessment. Patient characteristics were well-balanced between the study groups; most women (86%) underwent combined external beam radiotherapy and brachytherapy for cervical cancer and had a partner (77%). Approximately 80% of the women under the age of 45 with cervical cancer received hormonal replacement therapy. Women in the intervention group received an average of 4.4 (SD = 1.1) sessions, lasting 31 minutes (SD = 14.6) each. Partner participation started at 37% and declined over time to 15%. Women in both groups experienced decreased sexual functioning after radiotherapy as measured by the FSFI, followed by gradual improvement over the first year. No differences in FSFI scores were found between the groups at any timepoint (p=0.52); at 12 months FSFI scores were 22.53 in the intervention group versus 21.76 in the care as-usual group. The intervention did not significantly improve dilator compliance, reduce sexual distress or vaginal symptoms compared to care-as-usual. Both groups had minimal physician-reported vaginal stenosis. 70% of women reported being sexually active, and reported no or only little feeling of vaginal shortness, dryness and pain during intercourse (see figure 1). 84% of patients in the intervention group and 75% in the care-as-usual group reported using dilation (dilators, vibrator, dildo, fingers or intercourse combined) at least twice weekly. Results:
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