Abstract
BackgroundSexual 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/designThe 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).DiscussionThere 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 registrationClinicalTrials.gov, NCT03611517. Registered 2 August 2018.
Highlights
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)
EBRT+BT is the standard combination for primary treatment of more advanced stages of cervical, vaginal and endometrial cancer, while postoperative BT is only added in case of involved or tight vaginal margins
The nurses who were trained and supervised to guide the intervention felt capable to support the women. In this manuscript we present the design of the SPARC (Sexual rehabilitation Programme After Radiotherapy for gynaecological Cancer) study, a multicentre randomized controlled trial (RCT) which evaluates the effectiveness of the nurse-led sexual rehabilitation intervention in improving sexual functioning and dilator use of GC patients after RT
Summary
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). 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). One-third of GC patients, especially those with cervical, uterine and vaginal cancers, receive radiotherapy (RT) as primary or post-surgical treatment; most often external beam radiotherapy (EBRT) with or without brachytherapy (BT) Sexual problems, such as dyspareunia, vaginal dryness and a decrease of sexual satisfaction and desire are frequently reported after treatment with RT for GC [2,3,4,5,6,7,8,9]. A broader view on rehabilitation, counselling and support would be needed to help multi-dimensional recovery and increase compliance with regular dilator use
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