A Pilot Study of the Effectiveness of Acceptance and Commitment Therapy With a Post-Upper GI Cancer Population

April 4, 2016 updated by: Martin Dempster
This pilot research study aims to assess the effectiveness of an Acceptance and Commitment Therapy (ACT; Hayes Strosahl & Wilson, 2011) group based intervention at improving quality of life (QOL) and increasing Psychological Flexibility with survivors of Upper GI cancer following curative treatment. Participants will be invited to take part in an eight week intervention with outcomes being measured at baseline, midpoint, post-intervention and two month follow up. Outcomes will be compared with a randomised control group who will receive treatment as usual. Research has indicated that this population are under considerable psychological distress however within the UK there are currently no specifically tailored psychological interventions on offer to reduce this distress (Dempster, McCorry, Brennan, Donnelly, Murray & Johnston, 2012).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Design: This pilot study will take the form of a 2 group randomised controlled trial (intervention vs treatment as usual). Measures will be administered at baseline, midpoint, post-intervention and 2 month follow-up.

Setting: Outpatients' clinic. Target population: Adults with oesphagectomy in the previous 3-12 months for oesophageal cancer.

Exclusion Criteria: In receipt of a psychological intervention; have had a reoccurrence of the disease since their surgery; evidence of cognitive impairment impeding ability to engage with the intervention.

Health technology: A group-based acceptance and commitment therapy (ACT) intervention. There will be 2 intervention groups, both of which will receive an 8 week (1.5 hours per week) intervention.

Measurement of costs and outcomes: Participants will be allocated to treatment or control using a randomisation procedure, generated by a statistician outside the research team.

According to the COMET initiative, there are no recommended core outcomes available for use in oesophageal cancer. Work to develop these outcome measures is currently underway and the investigators will contact the authors of this work for the latest updates prior to submitting a full application to ensure that our choice of outcome measures is commensurate with any recommendations they are about to make. In the absence of this work being advanced sufficiently to inform this proposal, the following reliable and valid measures will be used: EORTC Quality of Life Questionnaire and Oesophageal Cancer Module, Acceptance and Action Questionnaire II, which provides a measure of psychological inflexibility, and (secondarily) Depression, Anxiety and Stress Scale.

Sample size: A sample size of 50 (25 per study arm).[42] This will also allow us to estimate a participation rate of 70% to within a 95% confidence interval of ±13%, which will inform the design of the definitive trial.

Current pathway: Patients can seek support for emotional issues from the specialist nurses in the service.

Expertise: Multidisciplinary team including cancer specialist nurses, a service user representative, health economist, statistician, psychologists and with expertise in the intervention to be tested, trials methodology, qualitative and quantitative methods, and research among people with oesophageal cancer

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults diagnosed with Upper GI/ Oesophageal cancer that have undergone an oesphagectomy between three to 12 months previously

Exclusion Criteria:

  • Are in receipt of a psychological intervention specifically to deal with the side effects of their oesphagectomy prior to stating the study group.
  • Have had a reoccurrence of the disease since their operation
  • Show evidence of cognitive impairment which may impede their ability to engage with the intervention.
  • Are zero to 3 months post medical intervention to cure their Upper GI/oesophageal cancer (oesphagetomy procedure).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
Acceptance and commitment therapy group
Behavioral: Acceptance and Commitment Therapy
ACT is a psychological intervention that aims to promote adaptive coping and encourages participants to move their focus away from trying to control emotions to accepting and adapting to them. It is relevant to all patients, not just those who are currently distressed.
NO_INTERVENTION: Comparison
Treatment as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in psychological flexibility assessed using the Acceptance and Action Questionnaire II
Time Frame: Pretest, approximately 8 weeks later and then another 3 months later
Pretest, approximately 8 weeks later and then another 3 months later

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Depression, anxiety and stress using the Depression Anxiety and Stress Scale 21
Time Frame: Pretest, approximately 8 weeks later and then another 3 months later
Pretest, approximately 8 weeks later and then another 3 months later
Change in Quality of life using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Oesophageal and Gastric Cancer
Time Frame: Pretest, approximately 8 weeks later and then another 3 months later
Pretest, approximately 8 weeks later and then another 3 months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Martin Dempster

Collaborators

Belfast Health and Social Care Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (ANTICIPATED)

April 1, 2016

Study Completion (ANTICIPATED)

April 1, 2016

Study Registration Dates

First Submitted

June 5, 2015

First Submitted That Met QC Criteria

July 7, 2015

First Posted (ESTIMATE)

July 8, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

April 5, 2016

Last Update Submitted That Met QC Criteria

April 4, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • B15/01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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