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

NCT02491372 | Withdrawn

• 1 other identifier: B15/01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• Change in psychological flexibility assessed using the Acceptance and Action Questionnaire II

  Pretest, approximately 8 weeks later and then another 3 months later

Secondary Outcomes (2)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

Acceptance and commitment therapy group

Behavioral: Acceptance and Commitment Therapy

Comparison

NO INTERVENTION

Treatment as usual

Interventions

Acceptance and Commitment Therapy BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Martin Dempster: lead
• Belfast Health and Social Care Trust: collaborator

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: June 5, 2015
• First Posted: July 8, 2015
• Study Start: September 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 5, 2016

Record last verified: 2016-04