Impact of Acceptance and Commitment Therapy on Early Stage Breast Cancer (ACT)

September 27, 2021 updated by: Jennifer A. Gregg, PhD, San Jose State University

Impact of Acceptance and Commitment Therapy on Salivary Cortisol in Breast Cancer

The purpose of this randomized controlled trial is to evaluate the effectiveness of an empirically supported psychosocial treatment, Acceptance and Commitment Therapy, in facilitating improved quality of life, benefit-finding, and cortisol rhythm in breast cancer patients in an outpatient clinical oncology setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Previous research indicates that breast cancer patients may demonstrate disrupted diurnal cortisol rhythms compared to healthy individuals, and that these disrupted rhythms may be related to recurrence and earlier mortality in some patients. Interestingly, improvements in cortisol regulation in previous intervention studies for cancer patients have not necessarily been related to decreased distress. Rather, improvements in post-traumatic growth, benefit-finding, and meaningfulness have also accounted for improved neuroendocrine and immunological changes.

Traditional breast cancer groups, however, may not adequately address these areas because existing interventions often target the reduction of distress as the primary vehicle to improve psychosocial, quality of life, and biophysical outcomes. Acceptance and Commitment Therapy (ACT) is an empirically-supported, mindfulness-based psychological treatment that has been shown to enhance meaningful behavior change thorough increasing emotional acceptance of difficult psychological experiences such as distress, without the goal of changing or eliminating them.

The current study seeks to determine the preliminary effect of an 8-week ACT group in increasing positive life changes and corresponding increase in salivary cortisol slope in 40 distressed breast cancer patients, who will be randomly assigned to ACT or a wait list control group.

The hypotheses for the present study include:

  • Patients receiving ACT will demonstrate improvements in Quality of Life (QoL), Benefit-finding (BF), and health behavior compared to control group participants
  • ACT participants will demonstrate improvements in mean cortisol levels and cortisol reactivity compared to control group participants
  • These changes will be the result of increased mindful acceptance of cancer-related distress and meaningful behavior changes, rather than a reduction in distress.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Jose, California, United States, 95192
        • San Jose State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosis of stage I-III breast cancer
  • prescreen distress score above defined cutoff
  • agreement not to seek other breast cancer support services until study completion

Exclusion Criteria:

  • previous cancer
  • prior psychiatric treatment for serious mental health disorder (e.g., hospitalization or formal diagnosis of psychosis, major depressive episode, borderline mental retardation, suicidality, or current substance dependence)
  • current use of medications known to interfere with cortisol levels (e.g., dexamethasone)
  • major concurrent medical disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Acceptance and Commitment Therapy group
8-week ACT group
Behavioral: Acceptance and Commitment Therapy
8-week ACT group
NO_INTERVENTION: Wait-list control group
Participants will be offered treatment following wait-list data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
salivary cortisol
Time Frame: 3-month follow-up
3-month follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
self-reported distress
Time Frame: 3-month follow-up
3-month follow-up
self-reported quality of life
Time Frame: 3-month follow-up
3-month follow-up
self-reported benefit-finding
Time Frame: 3-month follow-up
3-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Jose State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

July 15, 2010

First Submitted That Met QC Criteria

July 16, 2010

First Posted (ESTIMATE)

July 19, 2010

Study Record Updates

Last Update Posted (ACTUAL)

October 4, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5R03CA144751-02 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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