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

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 i...

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Autores principales:	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
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Health-related quality of life Sexual functioning Rehabilitation intervention Gynaecological cancer Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
Acceso en línea:	https://doaj.org/article/8e13b11875f646f690c99d271d0e1495
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spelling	oai:doaj.org-article:8e13b11875f646f690c99d271d0e14952021-12-05T12:19:29ZA sexual rehabilitation intervention for women with gynaecological cancer receiving radiotherapy (SPARC study): design of a multicentre randomized controlled trial10.1186/s12885-021-08991-21471-2407https://doaj.org/article/8e13b11875f646f690c99d271d0e14952021-12-01T00:00:00Zhttps://doi.org/10.1186/s12885-021-08991-2https://doaj.org/toc/1471-2407Abstract 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.Isabelle SuvaalSusanna B. HummelJan-Willem M. MensHelena C. van DoornWilbert B. van den HoutCarien L. CreutzbergMoniek M. ter KuileBMCarticleHealth-related quality of lifeSexual functioningRehabilitation interventionGynaecological cancerNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENBMC Cancer, Vol 21, Iss 1, Pp 1-14 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Health-related quality of life Sexual functioning Rehabilitation intervention Gynaecological cancer Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
spellingShingle	Health-related quality of life Sexual functioning Rehabilitation intervention Gynaecological cancer Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 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 A sexual rehabilitation intervention for women with gynaecological cancer receiving radiotherapy (SPARC study): design of a multicentre randomized controlled trial
description	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.
format	article
author	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
author_facet	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
author_sort	Isabelle Suvaal
title	A sexual rehabilitation intervention for women with gynaecological cancer receiving radiotherapy (SPARC study): design of a multicentre randomized controlled trial
title_short	A sexual rehabilitation intervention for women with gynaecological cancer receiving radiotherapy (SPARC study): design of a multicentre randomized controlled trial
title_full	A sexual rehabilitation intervention for women with gynaecological cancer receiving radiotherapy (SPARC study): design of a multicentre randomized controlled trial
title_fullStr	A sexual rehabilitation intervention for women with gynaecological cancer receiving radiotherapy (SPARC study): design of a multicentre randomized controlled trial
title_full_unstemmed	A sexual rehabilitation intervention for women with gynaecological cancer receiving radiotherapy (SPARC study): design of a multicentre randomized controlled trial
title_sort	sexual rehabilitation intervention for women with gynaecological cancer receiving radiotherapy (sparc study): design of a multicentre randomized controlled trial
publisher	BMC
publishDate	2021
url	https://doaj.org/article/8e13b11875f646f690c99d271d0e1495
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A sexual rehabilitation intervention for women with gynaecological cancer receiving radiotherapy (SPARC study): design of a multicentre randomized controlled trial

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