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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01164930
Recruitment Status : Unknown
Verified July 2011 by San Jose State University.
Recruitment status was:  Active, not recruiting
First Posted : July 19, 2010
Last Update Posted : July 21, 2011
Information provided by:
San Jose State University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Survivorship Stress Behavioral: Acceptance and Commitment Therapy Phase 2 Phase 3

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of Acceptance and Commitment Therapy on Salivary Cortisol in Breast Cancer
Study Start Date : January 2010
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

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

Primary Outcome Measures :
  1. salivary cortisol [ Time Frame: 3-month follow-up ]

Secondary Outcome Measures :
  1. self-reported distress [ Time Frame: 3-month follow-up ]
  2. self-reported quality of life [ Time Frame: 3-month follow-up ]
  3. self-reported benefit-finding [ Time Frame: 3-month follow-up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01164930

United States, California
San Jose State University
San Jose, California, United States, 95192
Sponsors and Collaborators
San Jose State University

Responsible Party: Jennifer A. Gregg, Ph.D., San Jose State University Identifier: NCT01164930     History of Changes
Other Study ID Numbers: 5R03CA144751-02 ( U.S. NIH Grant/Contract )
First Posted: July 19, 2010    Key Record Dates
Last Update Posted: July 21, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases