Clinical trial · Interventional
Low-Intensity CBT for Gynaecological Cancer Survivors
Evaluating Process and Effectiveness of Low-intensity Group Cognitive Behavioural Therapy for Women With Gynaecological Cancer: The EPELIT Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
There are 21,500 gynaecological cancers diagnosed in the UK each year. These are often diagnosed later than common cancers, which is predictive of low survival and high psychological distress. There are few studies published which accurately map the profile of distress and supportive care needs in gynaecological cancer patients, nor which test psychological interventions to support this group. This study will use a non-randomised controlled trial design to explore the potential benefits of taking part in a psychological intervention designed in this group of women. The intervention is group-delivered and runs for eight weeks. It is delivered by psychologists, psychological wellbeing practitioners, and cancer nurse specialists. The investigators will use validated self-report questionnaires to assess how helpful this intervention is at reducing distress and improving quality of life in the participants. This will be done in comparison with a treatment-as-usual control group recruited from a second clinical site. This second group of participants will not receive the psychological intervention, but they will complete the same assessments, at the same time points. To ensure participants are well supported, data collection in control control group participants will be done by telephone interview rather than self-report questionnaires. Both groups of participants will undertake a three-month follow-up assessment to check the longer-term effectiveness of the psychological intervention.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecological Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Group delivered Low Intensity Cognitive Behavioural Therapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Group
- description
- Group delivered Low Intensity Cognitive Behavioural Therapy (CBT).
- interventionNames
- Other: Group delivered Low Intensity Cognitive Behavioural Therapy
- type
- NO_INTERVENTION
- label
- Control Group
- description
- No intervention.
Primary outcomes (2)
- measure
- Patient Health Questionnaire (PHQ-9)
- timeFrame
- last 2 weeks
- description
- A nine-item screening tool to assess symptoms of depression in the responding individual (Kroenke, Spitzer, \& Williams, 2001). The PHQ-9 uses a four-point rating scale (ranging from 0 to 3) asking how often in the last two weeks participants have experienced symptoms pertaining to appetite, concentration, energy hopelessness, and suicidality. Higher scores indicate higher levels of distress. The PHQ-9 has been established as a valid and reliable measure of depression severity (Kroenke et al., 2001).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * Must be over the age of 16. * Must have received a gynecological cancer diagnosis. * Must have completed first line treatment within four months of the study start date (not restricted to any specific modality of treatment). * Must be able to speak English. * Must be able to provide consent. Exclusion Criteria: * Any patients that are unlikely to survive for the full five-month duration of the study. * Any patient who does not have sufficient English language ability to complete data collection. * Any patients who are notable to provide consent will not be included as this group would be unlikely to be able to complete data collection even if adjustments to the consent procedure were made.
References
Publications (1)
- DERIVEDHulbert-Williams NJ, Hulbert-Williams L, Flynn RJ, Pendrous R, MacDonald-Smith C, Mullard A, Swash B, Evans G, Price A. Evaluating process and effectiveness of a low-intensity CBT intervention for women with gynaecological cancer (the EPELIT Trial). AMRC Open Res. 2021 Mar 29;3:12. doi: 10.12688/amrcopenres.12971.1. eCollection 2021. PMID 38708072