SWELL-G:assessing sexual difficulties after gynaecological cancer V.1
Research type
Research Study
Full title
Feasibility Study of the Clinical Implementation of SWELL-G: a Patient Reported Outcome Measure (PROM) for Sexual Difficulties in Women Treated by Pelvic Surgery & / or Radiotherapy for Cervical or Endometrial Cancer
IRAS ID
249899
Contact name
Isabel D.White
Contact email
Sponsor organisation
The Royal Marsden NHS Foundation Trust
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
Research Summary:
Treatment for gynaecological cancer results in physical consequences and psychological responses that can impact negatively on women’s sexual well-being after treatment. Studies suggest that 50-80% of women experience treatment-related sexual difficulties. Clinical assessment and management of sexual difficulties after gynaecological cancer remains a frequently overlooked aspect of recovery and rehabilitation, with health professionals and women themselves having difficulty in raising this topic. Clearly, the first step towards being able to offer systematic management for the sexual consequences of cancer is timely and accurate clinical assessment.
The European Organisation for Research and Treatment of Cancer (EORTC) QoL group state that there is still no patient self-report measure that incorporates broader (physical, emotional and relational) aspects of sexual health or well-being for people affected by cancer. Initial development of a new clinical patient reported outcome measure (PROM) to assist in identification and management of women experiencing changes in sexual function and well-being (SWELL-G) was completed in 2014. In this current pilot study, 77 women will be recruited before introduction of the PROM and clinician inquiry rates and patient satisfaction with the consultation will be compared with a further 77 women evaluated after introduction of the new PROM in 2 gynae-oncology outpatient settings. Clinicians involved in post-treatment follow-up will receive training to use the PROM, together with local management and referral guidelines about female sexual consequences, before clinical assessment implementation. This study explores the implementation impact of a paper-based assessment (questionnaire) of female sexual difficulties on patient experience and clinical behaviours such as clinician inquiry / detection rates of sexual difficulties in routine follow-up consultations. It will also analyse the rates and patterns of medical notes documentation and onward referral for treatment-related sexual difficulties within / beyond the cancer centre.Summary of Results:
Sexual difficulties due to treatment occur in both cervical and endometrial cancer survivors, and their prevalence and impact may be underestimated because sexual concerns are rarely discussed in routine follow-up consultations. In addition, the clinical assessment and management of sexual difficulties after gynaecological cancer is still frequently overlooked in terms of recovery and rehabilitation, with health professionals and women themselves having difficulty in raising this topic. As a result, this study had two aims:
1. To evaluate whether an increased use of appropriate screening tools and questionnaires in routine hospital follow-up could:
a. support patient-clinician discussion
b. identify women and couples most in need of sexual rehabilitation c. improve self-management strategies and sexual rehabilitation resources available to patients
2. To pilot the use and determine whether it was feasible to implement the SWELL-G14 (a brief screening questionnaire) to assess how treatment affected sexual activity in women treated for endometrial or cervical cancer, in oncology follow-up (FUP) clinics.
The study was conducted in the natural environment of a gynae-oncology follow-up clinic in two English cancer centres where women are normally seen by a team of doctors and clinical nurse specialists (CNSs) for routine medical follow-up after treatment completion. Participants included women with a primary diagnosis of cervical cancer or endometrial cancer who had completed pelvic radiotherapy and/or surgery attending routine medical follow-up from 3 months to 5 years post-treatment. Participants were provided a number of questionnaires to complete including demographic questions, symptoms following treatment and questions about topics discussed during their appointment. The initial plan was to have two cohorts of participants – the first completing all the questionnaires after their appointment and the latter completing the brief screening questionnaire (SWELL-G14) before their appointment and the rest of the questionnaires after. Clinicians were trained in interpreting the screening questionnaire so that they could initiate a conversation focused on the topics of concern that patients had indicated in the screener. Unfortunately, due to the pandemic, the study had to be terminated before reaching the target number of participants which was 77 in each group. Instead, only the first cohort was completed with a total of 83 participants.
As a result, the first aim of the study could not be fulfilled. No comparisons between the two groups could be made and the opportunity for stronger findings that more participants could have offered was not provided. It also meant that the impact of using the screening questionnaire on supporting patient-clinician discussion, identifying women and couples most in need of sexual rehabilitation, and improving self-management strategies could not be assessed.
However, there was sufficient evidence to support that the brief screening questionnaire (SWELL-G14) was a valid, and reliable tool within its target population. The use of the SWELL-G14 into routine clinical practice would make it easier for both patients and clinicians to perform the clinical assessment. It would also provide a way of communicating that would support both parties in making it easier to discuss this important but sensitive rehabilitation topic.REC name
London - Queen Square Research Ethics Committee
REC reference
19/LO/0147
Date of REC Opinion
6 Mar 2019
REC opinion
Further Information Favourable Opinion