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

NCT ID: NCT03112668

Last Updated: 2021-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-06

Study Completion Date

2018-01-25

Brief Summary

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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

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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.

Conditions

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cognitive Behavior Therapy

Intervention Type BEHAVIORAL

Undergo ACT

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Cognitive Behavior Therapy

Undergo ACT

Intervention Type BEHAVIORAL

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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CBT cognitive therapy CT Quality of Life Assessment

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Sharon Manne, PhD

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sharon Manne

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Locations

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Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2017-00445

Identifier Type: REGISTRY

Identifier Source: secondary_id

Pro20170000115

Identifier Type: -

Identifier Source: secondary_id

131604

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA072720

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro20170000115

Identifier Type: -

Identifier Source: org_study_id

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