Impact of Acceptance and Commitment Therapy on Early Stage Breast Cancer (ACT)
Recruitment status was: Active, not recruiting
|Breast Neoplasms Survivorship Stress||Behavioral: Acceptance and Commitment Therapy||Phase 2 Phase 3|
|Study Design:||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|
- salivary cortisol [ Time Frame: 3-month follow-up ]
- self-reported distress [ Time Frame: 3-month follow-up ]
- self-reported quality of life [ Time Frame: 3-month follow-up ]
- self-reported benefit-finding [ Time Frame: 3-month follow-up ]
|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)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01164930
|United States, California|
|San Jose State University|
|San Jose, California, United States, 95192|