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

Phase 2/Phase 3
Open (Enrolling)
Breast Neoplasms, Survivorship, Stress

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Trial Information

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

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.

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.,

- major concurrent medical disease

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

salivary cortisol

Outcome Time Frame:

3-month follow-up

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

January 2010

Completion Date:

September 2011

Related Keywords:

  • Breast Neoplasms
  • Survivorship
  • Stress
  • Breast Neoplasms
  • Neoplasms



San Jose State University San Jose, California  95192