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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03112668
Enrollment
14
Registered
2017-04-13
Start date
2017-12-06
Completion date
2018-01-25
Last updated
2021-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

BEHAVIORALCognitive Behavior Therapy

Undergo ACT

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies

OTHERSurvey Administration

Ancillary studies

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Rutgers, The State University of New Jersey
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Exclusion criteria

* Partner cannot have cancer diagnosis (other than non-melanoma skin cancer) and be currently receiving treatment

Design outcomes

Primary

MeasureTime frameDescription
Change in acceptance as measured by the COPE acceptance subscaleBaseline to 1-week post interventionPre-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-IIBaseline to 1-week post interventionPre-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 questionnaireBaseline to 1-week post interventionPre-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 acceptanceUp to 1-week post interventionThis trial will be considered feasible if the acceptance rate among eligible patients is equal to or greater than 30%
Feasibility defined as session drop outUp to 1-week post interventionThis 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 upsUp to 1-week post interventionThis 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026