Impact of Acceptance and Commitment Therapy on Early Stage Breast Cancer (ACT)
|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms Survivorship Stress||Behavioral: Acceptance and Commitment Therapy||Phase 2 Phase 3|
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|
|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|
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
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01164930
|United States, California|
|San Jose State University|
|San Jose, California, United States, 95192|