Impact of Acceptance and Commitment Therapy on Early Stage Breast Cancer (ACT)
Primary Purpose
Breast Neoplasms, Survivorship, Stress
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acceptance and Commitment Therapy
Sponsored by

About this trial
This is an interventional supportive care trial for Breast Neoplasms
Eligibility 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
Sites / Locations
- San Jose State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Acceptance and Commitment Therapy group
Wait-list control group
Arm Description
8-week ACT group
Participants will be offered treatment following wait-list data collection
Outcomes
Primary Outcome Measures
salivary cortisol
Secondary Outcome Measures
self-reported distress
self-reported quality of life
self-reported benefit-finding
Full Information
NCT ID
NCT01164930
First Posted
July 15, 2010
Last Updated
September 27, 2021
Sponsor
San Jose State University
1. Study Identification
Unique Protocol Identification Number
NCT01164930
Brief Title
Impact of Acceptance and Commitment Therapy on Early Stage Breast Cancer
Acronym
ACT
Official Title
Impact of Acceptance and Commitment Therapy on Salivary Cortisol in Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Jose State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Survivorship, Stress
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acceptance and Commitment Therapy group
Arm Type
Experimental
Arm Description
8-week ACT group
Arm Title
Wait-list control group
Arm Type
No Intervention
Arm Description
Participants will be offered treatment following wait-list data collection
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy
Intervention Description
8-week ACT group
Primary Outcome Measure Information:
Title
salivary cortisol
Time Frame
3-month follow-up
Secondary Outcome Measure Information:
Title
self-reported distress
Time Frame
3-month follow-up
Title
self-reported quality of life
Time Frame
3-month follow-up
Title
self-reported benefit-finding
Time Frame
3-month follow-up
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
San Jose State University
City
San Jose
State/Province
California
ZIP/Postal Code
95192
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Impact of Acceptance and Commitment Therapy on Early Stage Breast Cancer
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