Acceptance and Commitment Therapy in Improving Well-Being in Patients With Stage III-IV Cancer and Their Partners
Primary Purpose
Malignant Female Reproductive System Neoplasm, Malignant Hepatobiliary Neoplasm, Partner
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavior Therapy
Quality-of-Life Assessment
Questionnaire Administration
Survey Administration
Sponsored by
About this trial
This is an interventional supportive care trial for Malignant Female Reproductive System Neoplasm
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
Sites / Locations
- Rutgers Cancer Institute of New Jersey
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Supportive Care (ACT)
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Feasibility defined as acceptance
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
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03112668
First Posted
March 28, 2017
Last Updated
April 7, 2021
Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03112668
Brief Title
Acceptance and Commitment Therapy in Improving Well-Being in Patients With Stage III-IV Cancer and Their Partners
Official Title
Couple-Focused ACT Intervention for Couples Coping With Cancer: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 6, 2017 (Actual)
Primary Completion Date
January 25, 2018 (Actual)
Study Completion Date
January 25, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supportive Care (ACT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavior Therapy
Other Intervention Name(s)
CBT, cognitive therapy, CT
Intervention Description
Undergo ACT
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Change in acceptance as measured by the COPE acceptance subscale
Description
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.
Time Frame
Baseline to 1-week post intervention
Title
Change in avoidance as measured by the Acceptance and Action Questionnaire-II
Description
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.
Time Frame
Baseline to 1-week post intervention
Title
Change in value based living as measured by the Valued Living questionnaire
Description
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.
Time Frame
Baseline to 1-week post intervention
Title
Feasibility defined as acceptance
Description
This trial will be considered feasible if the acceptance rate among eligible patients is equal to or greater than 30%
Time Frame
Up to 1-week post intervention
Title
Feasibility defined as session drop out
Description
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)
Time Frame
Up to 1-week post intervention
Title
Feasibility defined as survey follow ups
Description
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.
Time Frame
Up to 1-week post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Manne
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Acceptance and Commitment Therapy in Improving Well-Being in Patients With Stage III-IV Cancer and Their Partners
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