Clinical trial NCT03553784: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecological Cancer
Keywords: Cancer
Therapy
Lead sponsor: University of Chester
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 32
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pragmatic non-randomized controlled design.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: last 2 weeks
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: last 2 weeks
Secondary outcomes:
measure: The Functional Assessment of Cancer Therapy-General (FACT-G)
timeFrame: last 7 days
Other outcomes:
Locations:
city: Chester
country: United Kingdom
facility: Chester Research Unit for the Psychology of Health
state: Cheshire
Study officials:
affiliation: University of Chester
name: Nicholas J Hulbert-Williams, PhD
role: PRINCIPAL_INVESTIGATOR
References: