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NCT Number: NCT03112668

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

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.

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Key information

Conditions

Malignant Female Reproductive System Neoplasm Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Malignant Hepatobiliary Neoplasm Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Partner Prostatic Diseases Prostatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases 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 Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavior Therapy

Behavioral

Undergo ACT

Other names: CBT, cognitive therapy, CT

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Survey Administration

Other

Ancillary studies

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 13, 2017
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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