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

Stage IV Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03112668
• Other study ID #: Pro20170000115
• Secondary ID: NCI-2017-00445Pr
• Status: Completed
• Phase: N/A
• Start date: December 6, 2017
• Est. completion date: January 25, 2018

Study information

• Verified date: April 2021
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 25, 2018
• Est. primary completion date: January 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma
• Colorectal Neoplasms
• Genital Neoplasms, Female
• Lung Neoplasms
• Malignant Female Reproductive System Neoplasm
• Malignant Hepatobiliary Neoplasm
• Melanoma
• Neoplasms
• Partner
• Prostatic Neoplasms
• Skin Neoplasms
• 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
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• Cognitive Behavior Therapy
Undergo ACT

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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