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Completed

NCT Number: NCT03553784

Low-Intensity CBT for Gynaecological Cancer Survivors

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.

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Key information

Conditions

Gynecological Cancer Neoplasms

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chester Research Unit for the Psychology of Health

Chester, Cheshire, CH1 4BJ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group delivered Low Intensity Cognitive Behavioural Therapy

Other

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.

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

University of Chester

Other

Registry information

Official study title

Evaluating Process and Effectiveness of Low-intensity Group Cognitive Behavioural Therapy for Women With Gynaecological Cancer: The EPELIT Study

Acronym: EPELIT

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 12, 2018
Registry last updated
May 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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