Low-Intensity CBT for Gynaecological Cancer Survivors (EPELIT)

• ClinicalTrials.gov Identifier: NCT03553784
• Recruitment Status: Active, not recruiting
• First Posted: June 12, 2018
• Last Update Posted: June 18, 2018
• Sponsor: University of Chester
• Information provided by (Responsible Party): Nicholas J. Hulbert-Williams, University of Chester

Tracking Information

• First Submitted Date: May 30, 2018
• First Posted Date: June 12, 2018
• Last Update Posted Date: June 18, 2018
• Actual Study Start Date: April 3, 2018
• Estimated Primary Completion Date: September 28, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 30, 2018)

• Patient Health Questionnaire (PHQ-9) [ Time Frame: last 2 weeks ]
  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).
• Generalized Anxiety Disorder (GAD-7) [ Time Frame: last 2 weeks ]
  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).

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03553784 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: May 30, 2018)

The Functional Assessment of Cancer Therapy-General (FACT-G) [ Time Frame: last 7 days ]

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).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

A pragmatic non-randomized controlled design.

Masking: None (Open Label)
Primary Purpose: Supportive Care

• Condition: Gynecological Cancer

Intervention

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.

Study Arms

• Experimental: Intervention Group
  Group delivered Low Intensity Cognitive Behavioural Therapy (CBT).
  Intervention: Other: Group delivered Low Intensity Cognitive Behavioural Therapy
• No Intervention: Control Group
  No intervention.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: May 30, 2018): 106
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2019
• Estimated Primary Completion Date: September 28, 2019 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes

• Ages: 16 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT03553784
• Other Study ID Numbers: 239518
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes

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.

• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: 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

• Responsible Party: Nicholas J. Hulbert-Williams, University of Chester
• Study Sponsor: University of Chester
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Chester
• Verification Date: June 2018