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

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 demon‑ strate that psychosexual support should include cognitive behavioural interventions and involvement of the patient’s partner, if available. | Suvaal et al. BMC Cancer 2021 21 1295 https s12885-021-08991-2 STUDY PROTOCOL Open Access A sexual rehabilitation intervention for women with gynaecological cancer receiving radiotherapy SPARC study design of a multicentre randomized controlled trial Isabelle Suvaal1 Susanna B. Hummel1 Jan Willem M. Mens2 Helena C. van Doorn3 Wilbert B. van den Hout4 Carien L. Creutzberg5 and Moniek M. ter Kuile1 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 demon strate 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 psycho logical 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 .

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