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Spots Global Cancer Trial Database for Low-Intensity CBT for Gynaecological Cancer Survivors

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Trial Identification

Brief Title: Low-Intensity CBT for Gynaecological Cancer Survivors

Official Title: Evaluating Process and Effectiveness of Low-intensity Group Cognitive Behavioural Therapy for Women With Gynaecological Cancer: The EPELIT Study

Study ID: NCT03553784

Study Description

Brief 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.

Detailed Description:

Eligibility

Minimum Age: 16 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Chester Research Unit for the Psychology of Health, Chester, Cheshire, United Kingdom

Contact Details

Name: Nicholas J Hulbert-Williams, PhD

Affiliation: University of Chester

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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