A sexual rehabilitation intervention for women with gynaecological cancer receiving radiotherapy (SPARC study): design of a multicentre randomized controlled trial

Isabelle Suvaal, Susanna B Hummel, Jan-Willem M Mens, Helena C van Doorn, Wilbert B van den Hout, Carien L Creutzberg, Moniek M Ter Kuile, Isabelle Suvaal, Susanna B Hummel, Jan-Willem M Mens, Helena C van Doorn, Wilbert B van den Hout, Carien L Creutzberg, Moniek M Ter Kuile

Abstract

Background: Sexual problems are frequently reported after treatment with radiotherapy (RT) for gynaecological cancer (GC), in particular after combined external beam radiotherapy and brachytherapy (EBRT+BT). Studies demonstrate that psychosexual support should include cognitive behavioural interventions and involvement of the patient's partner, if available. Therefore, we developed a nurse-led sexual rehabilitation intervention, including these key components. The intervention was previously pilot-tested and results demonstrated that this intervention improves women's sexual functioning and increases dilator compliance. The objective of the current study is to investigate the (cost-)effectiveness of the intervention compared to optimal care as usual (CAU). We expect that women who receive the intervention will report a statistically significant greater improvement in sexual functioning and - for women who receive EBRT+BT - higher compliance with dilator use, from baseline to 12 months post-RT than women who receive optimal care as usual (CAU).

Methods/design: The intervention is evaluated in the SPARC (Sexual rehabilitation Programme After Radiotherapy for gynaecological Cancer) study, a multicentre, randomized controlled trial (RCT). The primary endpoint is sexual functioning. Secondary outcomes include body image, fear of sexual activity, sexual-, treatment-related- and psychological distress, health-related quality of life and relationship satisfaction. A cost-effectiveness analysis (CEA) will be conducted in which the costs of the intervention will be related to shifts in other health care costs and the impact on patient outcome. The study sample will consist of 220 women with GC treated with RT in specialized GC treatment centres (N = 10). Participants are randomized to either the intervention- or CAU control group (1:1), and within each centre stratified by type of radiotherapy (EBRT+BT vs. EBRT only) and having a partner (yes/no). All women complete questionnaires at baseline (T1) and at 1, 3, 6, and 12 months post-RT (T2, T3, T4 and T5, respectively).

Discussion: There is a need to improve sexual functioning after RT for GC. This RCT will provide evidence about the (cost-)effectiveness of a nurse-led sexual rehabilitation intervention. If proven effective, the intervention will be a much needed addition to care offered to GC survivors and will result in improved quality of life.

Trial registration: ClinicalTrials.gov, NCT03611517 . Registered 2 August 2018.

Keywords: Gynaecological cancer; Health-related quality of life; Rehabilitation intervention; Sexual functioning.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Overview of study procedures. *The physical examination at the 6 months follow-up visit might also be conducted by the gynaecologist (depending on the centre). BT = Brachytherapy; EBRT = External Beam Radiotherapy; GC = Gynaecological cancer; RT = Radiotherapy; T1 = Self-report baseline questionnaire, T2-5 = Self-report follow-up questionnaires
Fig. 2
Fig. 2
Decision Tree intervention modules. BT = Brachytherapy; EBRT = External Beam Radiotherapy; MI = Motivational Interviewing [35]; Module 1 = Brief sexual history; Module 2 = Pain during intercourse; Module 3 = Vaginal dryness and health; Module 4 = Alternatives for intercourse; Module 5 = The partner and possible sexual problems; Module 6 = Gradual exposure towards sexual intercourse; Module 7 = Pelvic floor exercise; Module 8 = Difficulties with dilator use at home; Module 9 = Using dilators under supervision at the outpatient clinic; Module 10 = Exploring and resolving ambivalence with regard to dilator use; Module 11 = Petroleum jelly (Vaseline) tampon

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