Acceptance and Commitment Therapy in Improving Well-Being in Patients With Stage III-IV Cancer and Their Partners

Not Applicable

Completed

• Conditions: Malignant Female Reproductive System Neoplasm; Stage IIIA Breast Cancer; Stage IIIA Colorectal Cancer; Stage IIIC Skin Melanoma; Stage IV Lung Cancer; Malignant Hepatobiliary Neoplasm; Stage III Colorectal Cancer; Stage IIIA Cervical Cancer; Stage IVA Uterine Corpus Cancer; Stage IVB Cervical Cancer
• Interventions: Behavioral: Cognitive Behavior Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Survey Administration

• Registration Number: NCT03112668
• Lead Sponsor: Rutgers, The State University of New Jersey

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.

Study Timeline

• Study First Submitted: 2017-03-28
• Study First Submitted QC: 2017-04-07
• Study First Posted: 2017-04-13
• Study Start: 2017-12-06
• Primary Completion: 2018-01-25
• Study Completion: 2018-01-25
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-07
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive Care (ACT)	Cognitive Behavior Therapy	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.
Supportive Care (ACT)	Questionnaire Administration	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.
Supportive Care (ACT)	Survey Administration	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.
Supportive Care (ACT)	Quality-of-Life Assessment	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Rutgers Cancer Institute of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States