Clinical trial NCT01164930: Impact of Acceptance and Commitment Therapy on Early Stage Breast Cancer
Official title: Impact of Acceptance and Commitment Therapy on Salivary Cortisol in Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Survivorship
Stress
Lead sponsor: San Jose State University
Sponsor class: OTHER
First posted: 2010-07-19
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: salivary cortisol
timeFrame: 3-month follow-up
Secondary outcomes:
measure: self-reported distress
timeFrame: 3-month follow-up
measure: self-reported quality of life
timeFrame: 3-month follow-up
measure: self-reported benefit-finding
timeFrame: 3-month follow-up
Other outcomes:
Locations:
city: San Jose
country: United States
facility: San Jose State University
state: California
Study officials:
References: