A Pilot Study of the Effectiveness of Acceptance and Commitment Therapy With a Post-Upper GI Cancer Population
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Primary Endpoint
- Change in psychological flexibility assessed using the Acceptance and Action Questionnaire II
Study Overview
Brief Summary
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).
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Change in Depression, anxiety and stress using the Depression Anxiety and Stress Scale 21(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(Pretest, approximately 8 weeks later and then another 3 months later)
Investigators
Martin Dempster
Senior Lecturer
Queen's University, Belfast