Sexual Morbidity Assessment in Gyne-Oncology Follow-Up: Development of the Sexual Well-Being After Cervical or Endometrial Cancer (SWELL-CE) Patient-Reported Outcome Measure

Background: Clinical assessment and management of sexual difficulties after gynecological cancer remain a neglected aspect of women’s rehabilitation. Aim: To develop and validate a patient-reported outcome measure of sexual well-being for women experiencing sexual consequences of cervical and endometrial cancer treatment for use in routine follow-up. Methods: This is a sequential mixed method study comprising (i) in-depth qualitative interviews (n¼21 of 118) to generate items regarding sexual consequences of cervical or endometrial cancer and treatment; (ii) questionnaire construction with 51 core items (all respondents) and 4 subsections (18e58 items), depending on the relationship status and whether or not participants were sexually active (SA/NSA); (iii) item refinement following cognitive debriefing (n¼13 of 21); (iv) validation of resultant items via postal survey (n¼788 women) and Rasch analysis; and (v) creation of brief (14-item) clinical screener. Women attending routine follow-up (3 months to 5 years) at 6 English cancer centers and members of 3 UK cancer patient websites, who met the study inclusion criteria, were invited to participate. Outcomes: The primary outcome of this study was the construction and initial psychometric testing of SWELLCE short and long form versions. Results: 21 women participated in interviews and 250 of 788 (32%) returned the postal survey (T1). 110 draft items were evaluated using cognitive testing (n¼13) to refine instrument design and test face validity, comprehension, and acceptability. Exploratory factor analysis of survey data (n¼250) produced an initial 6 domain structure as a guidance for the Rasch analysis. Subsequent Rasch analysis yielded a 3 domain structure: physical sexual function, sexual and relationship concerns, and sexual desire and sexual self-esteem, each satisfying Rasch model requirements within their respective SA (item pool ¼59) and NSA (item pool ¼53) categories, including the absence of local response dependency and all showing strict unidimensionality. The 3 subscales demonstrated good psychometric properties, external validity, and test-retest reliability. A valid Rasch short form of 14 items was created from the larger item pool. Clinical Implications: This PROM may assist clinicians to improve identification, discussion, and management of women who could benefit from sexual rehabilitation. Strengths & Limitations: Initial evaluation supports psychometric validity and reliability in the assessment of physical sexual function, sexual interest and sexual self-esteem, and sexual and relationship concerns in this study sample. However, given this study’s modest response rate (32%, n¼250), findings should be interpreted with caution. This PROM identifies sexual concerns in women who are sexually active or sexually non-active due to illness or treatment-associated sexual difficulties. Conclusion: Sexual Well-being after Cervical or Endometrial Cancer is a novel and psychometrically valid sexual well-being measure for clinical assessment of female sexual difficulties after cervical or endometrial cancer treatment