NCT03553784

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of Chester · Academic / Other
• Sex: Female
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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

• Gynecological Cancer

Interventions

Type	Name	Description
OTHER	Group delivered Low Intensity Cognitive Behavioural Therapy	The intervention is group-delivered, low-intensity CBT similar to that used in IAPT (Improving Access to Psychological Therapies) Services in England. This intervention is already being offered as part of standard care at the Intervention site, and will not be altered by the study protocol, other than the requirement to complete a few more questionnaires. The intervention group meets weekly for eight weeks, and is facilitated by a clinical psychologist, a psychological well-being practitioner and a clinical nurse specialist from the medical oncology team. Content of the intervention is broad CBT, combining aspects of second-wave CBT, with elements of Narrative Therapy and ACT.

Timeline

• Start date: 2018-04-03
• Primary completion: 2020-01-30
• Completion: 2020-05-02
• First posted: 2018-06-12
• Last updated: 2020-05-11

Locations

1 site across 1 country: United Kingdom