Evidence map›Paper›PMID 34863145›Full record

ArticleBMC cancer2021

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

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03611517 (SPARC Study), which is not on this map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03611517 naunknown statusnot on this map

SPARC Study: A Nurse-led Sexual Rehabilitation Programme for Women With Gynaecological Cancers Receiving Radiotherapy: a Randomized Multicentre Trial

TypeinterventionalSponsorLeiden University Medical CenterRan2018 to 2022Enrolled220ConditionsEndometrial Cancer, Cervical Cancer, Vaginal Cancer, Gynecologic CancerArmsSexual rehabilitation programme
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Review
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Isabelle SuvaalDepartment of Gynaecology, Leiden University Medical Center, Zone K6-T, PO Box 9600, 2300 RC, Leiden, the Netherlands. i.suvaal@lumc.nl.ORCID http://orcid.org/0000-0002-2101-110X
Susanna B HummelDepartment of Gynaecology, Leiden University Medical Center, Zone K6-T, PO Box 9600, 2300 RC, Leiden, the Netherlands.
Jan-Willem M MensDepartment of Radiotherapy, Erasmus Medical Center Cancer Institute, Rotterdam, the Netherlands.
Helena C van DoornDepartment of Gynaecology, Erasmus Medical Center Cancer Institute, Rotterdam, the Netherlands.
Wilbert B van den HoutDepartment of Biomedical Data Sciences, Leiden University Medical Center, Leiden, the Netherlands.
Carien L CreutzbergDepartment of Radiation Oncology, Leiden University Medical Center, Leiden, the Netherlands.
Moniek M Ter KuileDepartment of Gynaecology, Leiden University Medical Center, Zone K6-T, PO Box 9600, 2300 RC, Leiden, the Netherlands.

Funding

KWF Kankerbestrijding 10674
6 · The paper itself

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). 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 registrationClinicalTrials.gov, NCT03611517 . Registered 2 August 2018.

Indexed as

Cost-Benefit AnalysisFemaleGenital Neoplasms, FemaleHumansMulticenter Studies as TopicPsychiatric RehabilitationQuality of LifeRandomized Controlled Trials as TopicSexual BehaviorGynaecological cancerHealth-related quality of lifeRehabilitation interventionSexual functioning

Identifiers

PMID34863145
PMCPMC8642903

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.