Clinical Trials Directory

Trials / Completed

CompletedNCT01164930

Impact of Acceptance and Commitment Therapy on Early Stage Breast Cancer

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (actual)
Sponsor
San Jose State University · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALAcceptance and Commitment Therapy8-week ACT group

Timeline

Start date
2010-01-01
Primary completion
2011-09-01
Completion
2011-09-01
First posted
2010-07-19
Last updated
2021-10-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01164930. Inclusion in this directory is not an endorsement.

Impact of Acceptance and Commitment Therapy on Early Stage Breast Cancer (NCT01164930) · Clinical Trials Directory