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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
San Jose State University
ClinicalTrials.gov Identifier:
NCT01164930
First received: July 15, 2010
Last updated: July 20, 2011
Last verified: July 2011
History of Changes
  Purpose

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 Intervention Phase
Breast Neoplasms
Survivorship
Stress
 Behavioral: Acceptance and Commitment Therapy
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Impact of Acceptance and Commitment Therapy on Salivary Cortisol in Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by San Jose State University:

Primary Outcome Measures:
  • salivary cortisol [ Time Frame: 3-month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • self-reported distress [ Time Frame: 3-month follow-up ] [ Designated as safety issue: No ]
  • self-reported quality of life [ Time Frame: 3-month follow-up ] [ Designated as safety issue: No ]
  • self-reported benefit-finding [ Time Frame: 3-month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01164930

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

No publications provided

Responsible Party: Jennifer A. Gregg, Ph.D., San Jose State University
ClinicalTrials.gov Identifier: NCT01164930     History of Changes
Other Study ID Numbers: 5R03CA144751-02
Study First Received: July 15, 2010
Last Updated: July 20, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 17, 2013