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

Sponsor

Rutgers, The State University of New Jersey (Other)

Overall Status

Completed

CT.gov ID

NCT03112668

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

1.6

Actual Duration (Months)

8.5

Patients Per Site Per Month

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.

Condition or Disease	Intervention/Treatment	Phase
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 Skin Melanoma 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	Behavioral: Cognitive Behavior Therapy Other: Quality-of-Life Assessment Other: Questionnaire Administration Other: Survey Administration	N/A

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

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Dec 6, 2017

Actual Primary Completion Date :

Jan 25, 2018

Actual Study Completion Date :

Jan 25, 2018

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: CBT cognitive therapy CT Other: Quality-of-Life Assessment Ancillary studies Other Names: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies Other: Survey Administration Ancillary studies

Arm

Intervention/Treatment

Experimental: Supportive Care (ACT)

Behavioral: Cognitive Behavior Therapy

Undergo ACT

Other Names:

CBT

cognitive therapy

Other: Quality-of-Life Assessment

Ancillary studies

Other Names:

Quality of Life Assessment

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

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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