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

Study 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.

Official Title
-----------------
Couple-Focused ACT Intervention for Couples Coping With Cancer: A Pilot Study

Conditions
-----------------
Stage IV Skin Melanoma, Malignant Female Reproductive System Neoplasm, Malignant Hepatobiliary Neoplasm, Partner, Stage III Breast Cancer, Stage III Cervical Cancer, Stage III Colorectal Cancer, Stage III Lung Cancer, Stage III Prostate Cancer, Stage III Skin Melanoma, Stage III Uterine Corpus Cancer, Stage IIIA Breast Cancer, Stage IIIA Cervical Cancer, Stage IIIA Colorectal Cancer, Stage IIIA Lung Carcinoma, Stage IIIA Skin Melanoma, Stage IIIA Uterine Corpus Cancer, Stage IIIB Breast Cancer, Stage IIIB Cervical Cancer, Stage IIIB Colorectal Cancer, Stage IIIB Lung Carcinoma, Stage IIIB Skin Melanoma, Stage IIIB Uterine Corpus Cancer, Stage IIIC Breast Cancer, Stage IIIC Colorectal Cancer, Stage IIIC Skin Melanoma, Stage IIIC Uterine Corpus Cancer, Stage IV Breast Cancer, Stage IV Cervical Cancer, Stage IV Colorectal Cancer, Stage IV Lung Cancer, Stage IV Prostate Cancer, Stage IV Uterine Corpus Cancer, Stage IVA Cervical Cancer, Stage IVA Colorectal Cancer, Stage IVA Uterine Corpus Cancer, Stage IVB Cervical Cancer, Stage IVB Colorectal Cancer, Stage IVB Uterine Corpus Cancer

Intervention / Treatment
-----------------
* Behavioral: Cognitive Behavior Therapy
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration
* Other: Survey Administration


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive Care (ACT)<br>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<br>* Undergo ACT<br>* Other names: CT;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Survey Administration<br>* Ancillary studies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in acceptance as measured by the COPE acceptance subscale | 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. | Baseline to 1-week post intervention | 
| Change in avoidance as measured by the Acceptance and Action Questionnaire-II | 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. | Baseline to 1-week post intervention | 
| Change in value based living as measured by the Valued Living questionnaire | 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. | Baseline to 1-week post intervention | 
| Feasibility defined as acceptance | This trial will be considered feasible if the acceptance rate among eligible patients is equal to or greater than 30% | Up to 1-week post intervention | 
| Feasibility defined as session drop out | 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) | Up to 1-week post intervention | 
| Feasibility defined as survey follow ups | 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. | Up to 1-week post intervention |