Clinical trial NCT03112668: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-04-13
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in acceptance as measured by the COPE acceptance subscale
timeFrame: Baseline to 1-week post intervention
measure: Change in avoidance as measured by the Acceptance and Action Questionnaire-II
timeFrame: Baseline to 1-week post intervention
measure: Change in value based living as measured by the Valued Living questionnaire
timeFrame: Baseline to 1-week post intervention
measure: Feasibility defined as acceptance
timeFrame: Up to 1-week post intervention
measure: Feasibility defined as session drop out
timeFrame: Up to 1-week post intervention
measure: Feasibility defined as survey follow ups
timeFrame: Up to 1-week post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Sharon Manne
role: PRINCIPAL_INVESTIGATOR
References: