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

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ClinicalTrials.gov Identifier: NCT03112668
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : February 7, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey

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.

Condition or disease Intervention/treatment Phase
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 Behavioral: Cognitive Behavior Therapy Other: Quality-of-Life Assessment Other: Questionnaire Administration Other: Survey Administration Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Couple-Focused ACT Intervention for Couples Coping With Cancer: A Pilot Study
Actual Study Start Date : December 6, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019


Arm Intervention/treatment
Experimental: 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.
Behavioral: Cognitive Behavior Therapy
Undergo ACT
Other Names:
  • CBT
  • cognitive therapy
  • CT

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Other: Survey Administration
Ancillary studies




Primary Outcome Measures :
  1. Change in acceptance as measured by the COPE acceptance subscale [ Time Frame: Baseline to 1-week post intervention ]
    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.

  2. Change in avoidance as measured by the Acceptance and Action Questionnaire-II [ Time Frame: Baseline to 1-week post intervention ]
    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.

  3. Change in value based living as measured by the Valued Living questionnaire [ Time Frame: Baseline to 1-week post intervention ]
    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.

  4. Feasibility defined as acceptance [ Time Frame: Up to 1-week post intervention ]
    This trial will be considered feasible if the acceptance rate among eligible patients is equal to or greater than 30%

  5. Feasibility defined as session drop out [ Time Frame: Up to 1-week post intervention ]
    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)

  6. Feasibility defined as survey follow ups [ Time Frame: Up to 1-week post intervention ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112668


Locations
United States, New Jersey
Rutgers Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Sharon Manne    732-235-6759    mannesl@cinj.rutgers.edu   
Principal Investigator: Sharon Manne         
Sponsors and Collaborators
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)
Investigators
Principal Investigator: Sharon Manne Rutgers Cancer Institute of New Jersey

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT03112668     History of Changes
Other Study ID Numbers: 131604
NCI-2017-00445 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Pro20170000115
131604 ( Other Identifier: Rutgers Cancer Institute of New Jersey )
P30CA072720 ( U.S. NIH Grant/Contract )
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma
Breast Neoplasms
Prostatic Neoplasms
Neoplasms
Melanoma
Colorectal Neoplasms
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Intestinal Neoplasms
Gastrointestinal Neoplasms