Impact of Acceptance and Commitment Therapy on Early Stage Breast Cancer

Stress Clinical Trial

— ACT  

Official title:

Impact of Acceptance and Commitment Therapy on Salivary Cortisol in Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01164930
• Other study ID #: 5R03CA144751-02
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: September 2011

Study information

• Verified date: September 2021
• Source: San Jose State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Stress
• Survivorship

Intervention

Behavioral:
• Acceptance and Commitment Therapy
8-week ACT group

Locations

Country	Name	City	State
United States	San Jose State University	San Jose	California

Sponsors (1)

Lead Sponsor	Collaborator
San Jose State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	salivary cortisol		3-month follow-up
Secondary	self-reported distress		3-month follow-up
Secondary	self-reported quality of life		3-month follow-up
Secondary	self-reported benefit-finding		3-month follow-up