Gynaecological cancer Cancer
Conditions
Interventions
Recruitment
Following ERGO (University of Southampton) and NHS/REC approval, patients who attend their appointments at sites within the South-Central RRDN may be approached and informed about the stud
Sponsors
University of Southampton
Eligibility
Sex/Gender
Female
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Biological women aged 18 years or older 2. Diagnosed with a form of gynaecological cancer (e.g., cervical, ovarian, uterine, vaginal, vulvar or fallopian tube) as a primary diagnosis 3. Either in active treatment or remission
Exclusion criteria
Exclusion criteria: 1. Attending or previous attendance of SR groups, specifically 2. Women with cancer of unknown primary, or gynaecological cancer as secondary 3. Currently receiving other psychological interventions (e.g., counselling, CBT) 4. Unable to comprehend the study and/or provide informed consent (e.g., insufficient command of English in the absence of someone who can adequately interpret)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measures (feasibility) 1. Recruitment demand will be measured by the number of eligible participants who express interest versus the required sample size, recorded continuously throughout the recruitment period. 2. Recruitment efficiency will be measured by the total time taken to recruit the target sample, recorded continuously throughout the recruitment period. 3. Reasons for declining participation will be measured through documentation of participant-reported reasons at the point of initial contact. 4. Retention rates will be measured by the percentage of enrolled participants who complete the intervention, calculated at week 6 (post-intervention). 5. Session attendance is measured by the number of oSR sessions attended per participant (out of 6 total sessions), recorded continuously from baseline (week 0) to week 6. 6. Intervention completion rate is measured by the percentage of participants who attend all 6 oSR sessions, calculated at week 6 (post-intervention). 7. Acceptability and satisfaction with the online Shared Reading (oSR) intervention will be measured using qualitative individual semi-structured interviews lasting up to 30 minutes, conducted at week 6 (post-intervention). 8. Reasons for dropout are measured through a brief exit survey administered at the point of participant withdrawal. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures (preliminary individual-level outcomes) are assessed at baseline 1 (week -2), baseline 2 (week -1), baseline 3 (week 0), mid-intervention (week 3), and post-intervention (week 6): 1. Psychological distress will be measured using the Kessler-10 (K10) 2. Psychological wellbeing will be measured using the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) 3. Social quality of life will be measured using the World Health Organization Quality of Life Social Domain Subscale (WHOQOL-Social) 4. Global health and quality of life will be measured using the 2 global items from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30) | — |
Countries
United Kingdom
Contacts
Public ContactSonia Tomescu
Outcome results
None listed