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Low-Intensity CBT for Gynaecological Cancer Survivors (EPELIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03553784
Recruitment Status : Active, not recruiting
First Posted : June 12, 2018
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Nicholas J. Hulbert-Williams, University of Chester

Tracking Information
First Submitted Date  ICMJE May 30, 2018
First Posted Date  ICMJE June 12, 2018
Last Update Posted Date June 18, 2018
Actual Study Start Date  ICMJE April 3, 2018
Estimated Primary Completion Date September 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History Complete list of historical versions of study NCT03553784 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low-Intensity CBT for Gynaecological Cancer Survivors
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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  ICMJE Gynecological Cancer
Intervention  ICMJE 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 30, 2018)
106
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date September 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03553784
Other Study ID Numbers  ICMJE 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  ICMJE
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  ICMJE University of Chester
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nicholas J Hulbert-Williams, PhD University of Chester
PRS Account University of Chester
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP