Couple-Focused ACT Intervention for Couples Coping With Cancer: A Pilot Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Malignant Female Reproductive System Neoplasm
- Sponsor
- Rutgers, The State University of New Jersey
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Change in acceptance as measured by the COPE acceptance subscale
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This pilot clinical trial studies how well acceptance and commitment therapy works in improving well-being in patients with stage III-IV cancer and their partners. Learning how to accept negative thoughts and feelings and how to live in the present without worrying about the future or past may improve coping skills in patients with stage III-IV cancer and their partners.
Detailed Description
PRIMARY OBJECTIVES: I. To examine the feasibility and acceptability of couples' acceptance and commitment therapy (ACT) (C-ACT). II. To collect pilot data on the impact of C-ACT on patients' and partners' anxiety, depression, and quality of life. OUTLINE: Patients and their partners attend 6 weekly ACT sessions over 60-75 minutes. Couples learn skills of acceptance, avoidance, awareness, values and committed action, mindfulness and values in relationships, and handling persistent worries and concerns. Patients and their partners also do homework assignment after each session. After completion of the study, patients and their partners are followed up at 1 week.
Investigators
Sharon Manne, PhD
Professor of Medicine
Rutgers Cancer Institute of New Jersey
Eligibility Criteria
Inclusion Criteria
- •Diagnosed with stage 3 or 4 breast, cervical, colorectal, endometrial, hepatobiliary, lung, melanoma, gynecological, prostate cancer in the past six months
- •Married or cohabiting with a significant other of either gender for more than one year
- •At the time of recruitment, a life expectancy of greater than 6 months and/or a Karnofsky performance status of 80 or above or an Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- •English speaking
- •No significant hearing impairment that would prevent participation in sessions
- •Live within a 1 hour commuting distance from Rutgers Cancer Institute of New Jersey
Exclusion Criteria
- •Partner cannot have cancer diagnosis (other than non-melanoma skin cancer) and be currently receiving treatment
Outcomes
Primary Outcomes
Change in acceptance as measured by the COPE acceptance subscale
Time Frame: Baseline to 1-week post intervention
Pre-post changes will be examined using t-tests in the primary outcomes as well as the mechanisms of change (e.g., flexibility, avoidance self-disclosure). Because this is primarily a pilot and feasibility study and not an efficacy test, these data will be used primarily to examine whether an impact on distress and well-being was made but statistical significance will not be the primary aim.
Change in avoidance as measured by the Acceptance and Action Questionnaire-II
Time Frame: Baseline to 1-week post intervention
Pre-post changes will be examined using t-tests in the primary outcomes as well as the mechanisms of change (e.g., flexibility, avoidance self-disclosure). Because this is primarily a pilot and feasibility study and not an efficacy test, these data will be used primarily to examine whether an impact on distress and well-being was made but statistical significance will not be the primary aim.
Change in value based living as measured by the Valued Living questionnaire
Time Frame: Baseline to 1-week post intervention
Pre-post changes will be examined using t-tests in the primary outcomes as well as the mechanisms of change (e.g., flexibility, avoidance self-disclosure). Because this is primarily a pilot and feasibility study and not an efficacy test, these data will be used primarily to examine whether an impact on distress and well-being was made but statistical significance will not be the primary aim.
Feasibility defined as acceptance
Time Frame: Up to 1-week post intervention
This trial will be considered feasible if the acceptance rate among eligible patients is equal to or greater than 30%
Feasibility defined as session drop out
Time Frame: Up to 1-week post intervention
This trial will be considered feasible if drop out from sessions (at any point over the 6 sessions) is less than 20% (thus, 6/30)
Feasibility defined as survey follow ups
Time Frame: Up to 1-week post intervention
This trial will be considered feasible if 3) completion of study surveys at the follow up is 80%, and patients are not lost to progressive disease.