Depression Clinical Trial
Official title:
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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