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

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.

Study Overview

• Status: Completed
• Conditions: Gynecological Cancer
• Intervention / Treatment: Other: Group delivered Low Intensity Cognitive Behavioural Therapy

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cheshire
    • Chester, Cheshire, United Kingdom, CH1 4BJ
      • Chester Research Unit for the Psychology of Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; No intervention.
Experimental: Intervention Group; Group delivered Low Intensity Cognitive Behavioural Therapy (CBT).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Functional Assessment of Cancer Therapy-General (FACT-G)	A 33-item screening tool to assess quality-of-life in patients receiving cancer treatment (Cella et al., 1993). The FACT-G uses a five-point rating scale (ranging from 0 to 4) asking how often in the last seven days patients have experienced difficulties in four dimensions of well-being: physical; social/family; emotional; functional. Higher scores indicate lower quality-of-life. The FACT-G is a well validated tool for measuring quality-of-life in cancer sample (Luckett et al., 2011).	last 7 days

Collaborators and Investigators

• Sponsor: University of Chester
• Investigators: Principal Investigator: Nicholas J Hulbert-Williams, PhD, University of Chester

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2018
• Primary Completion (Actual): January 30, 2020
• Study Completion (Actual): May 2, 2020

Study Registration Dates

• First Submitted: May 30, 2018
• First Submitted That Met QC Criteria: May 30, 2018
• First Posted (Actual): June 12, 2018

Study Record Updates

• Last Update Posted (Actual): May 11, 2020
• Last Update Submitted That Met QC Criteria: May 8, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Cancer; Therapy
• Other Study ID Numbers: 239518

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing Access Criteria: To be developed by our Study Steering Group nearer to the end of study completion
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No