Low-Intensity CBT for Gynaecological Cancer Survivors
EPELIT
Evaluating Process and Effectiveness of Low-intensity Group Cognitive Behavioural Therapy for Women With Gynaecological Cancer: The EPELIT Study
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 3, 2018
CompletedFirst Submitted
Initial submission to the registry
May 30, 2018
CompletedFirst Posted
Study publicly available on registry
June 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 2, 2020
CompletedMay 11, 2020
May 1, 2020
1.8 years
May 30, 2018
May 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Patient Health Questionnaire (PHQ-9)
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).
last 2 weeks
Generalized Anxiety Disorder (GAD-7)
A seven-item screening tool to assess symptoms of anxiety in the responding individual (Spitzer, Kroenke, Williams, \& Löwe, 2006). The GAD-7 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 feeling anxious, worried, difficulty relaxing, and irritability. Higher scores indicate higher distress. The GAD-7 has been established as an accurate measure of anxiety (Swinson, 2006).
last 2 weeks
Secondary Outcomes (1)
The Functional Assessment of Cancer Therapy-General (FACT-G)
last 7 days
Study Arms (2)
Intervention Group
EXPERIMENTALGroup delivered Low Intensity Cognitive Behavioural Therapy (CBT).
Control Group
NO INTERVENTIONNo intervention.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chester Research Unit for the Psychology of Health
Chester, Cheshire, CH1 4BJ, United Kingdom
Related Publications (1)
Hulbert-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: 38708072DERIVED
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Nicholas J Hulbert-Williams, PhD
University of Chester
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 30, 2018
First Posted
June 12, 2018
Study Start
April 3, 2018
Primary Completion
January 30, 2020
Study Completion
May 2, 2020
Last Updated
May 11, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- We will make data available to others wishing to verify our analyses from the end of the study onward. We will impose a 24-month embargo after study end before releasing data for use for new analyses to other research teams.
- Access Criteria
- To be developed by our Study Steering Group nearer to the end of study completion
An anonymised dataset will be prepared once our study is completed, primarily to ensure that access can be provided to journal editors and peer reviewers if requested through the publishing and dissemination process. We would consider requests to share this data with other research teams, provided that individual participants have consented to this . In releasing such data we will include self-report psychological measures, demographics as reported to the research team by the participant, and clinical data as extracted from patient records. We will not release information on hospital site, simply reporting that participants were recruited from anonymised UK hospitals. Thus, without access to how these match NHS records, it ought not to be possible to identify individuals from this dataset. This is carefully explained to participants in the study information sheets as an assurance of commitment to participant anonymity.