Stress Reduction in Improving Quality of Life in Patients With Recurrent Gynecologic or Breast Cancer

PRIMARY OBJECTIVES:

I. To refine the intervention. II. Test the acceptability, feasibility, and clinical
appropriateness of the intervention.

III. To provide a preliminary test of its efficacy.

OUTLINE:

Patients participate in a multi-component intervention based on cognitive and behavioral
principles comprising mindfulness-based stress reduction (MBSR), an intervention to promote
hopefulness, and a problem solving approach which navigates around obstacles or generates
alternatives when goals become blocked. Additional topics may be covered as indicated by
clinical need and patients goals. Biobehavioral components include addressing social and
disease-specific quality of life, and pain education. Intensive treatment sessions continue
weekly for 16 weeks followed by 2 biweekly and 2 monthly maintenance sessions.

After completion of study treatment, patients are followed up at 28 weeks.

Inclusion Criteria:

- Diagnosis of recurrent breast or gynecologic cancer (any site) with any disease-free
interval; second primary cancers do not meet this criterion

- English speaking

- Able and willing to give informed consent

- To be considered for the blood and saliva collection, women must fulfill the
following secondary criteria:

- Diagnosis of recurrent breast or ovarian cancer with any disease-free interval

Exclusion Criteria:

- Residence > 70 miles from research site

- Subnormal intellectual potential (diagnosis of mental retardation)

- Progressive neurological or chronic, progressive, debilitating condition (e.g.,
dementia)

- Non-ambulatory

- Life expectancy less than 160 days, per the treating oncologist

- Current suicide risk sufficient to preclude treatment on an outpatient basis

- Chronic inflammatory or autoimmune disorder (e.g., rheumatoid arthritis, lupus)