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

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: Breast Neoplasms; Stress; Survivorship
• Intervention / Treatment: Behavioral: Acceptance and Commitment Therapy

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	3-month follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: San Jose State University

Study record dates

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: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 5R03CA144751-02 (NIH)