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

A Biobehavioral Intervention for Patients With Gynecologic or Breast Cancer Recurrence

This pilot clinical trial studies stress reduction in improving quality of life in patients with recurrent gynecologic or breast cancer. Participating in a stress reduction program may help improve quality of life in patients with 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)