Acceptance and Commitment Therapy in Improving Well-Being in Patients With Stage III-IV Cancer and Their Partners
Study Details
Study Description
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:
-
To examine the feasibility and acceptability of couples' acceptance and commitment therapy (ACT) (C-ACT).
-
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Supportive Care (ACT) 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. |
Behavioral: Cognitive Behavior Therapy
Undergo ACT
Other Names:
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
Other: Questionnaire Administration
Ancillary studies
Other: Survey Administration
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- Change in acceptance as measured by the COPE acceptance subscale [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 [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 [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 [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 [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 [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.
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | United States | 08903 |
Sponsors and Collaborators
- Rutgers, The State University of New Jersey
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Sharon Manne, Rutgers Cancer Institute of New Jersey
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro20170000115
- NCI-2017-00445
- Pro20170000115
- 131604
- P30CA072720