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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
39
Ancillary studies
Patients will participate in a quality life assessment.
Participate in multi-component biobehavioral intervention
Participate in multi-component biobehavioral intervention
A multi-component intervention based on cognitive and behavioral principles will be used. It combines effective intervention strategies selected for their relevance to patients with recurrent cancer.
Participate in multi-component biobehavioral intervention
Ohio State University Medical Center
Columbus, Ohio, United States
Quality of life(QoL)
Quality of life as assessed by Short Form (SF)-36
Time frame: up to 28 weeks
Mood as assessed by the Profile of Mood States (POMS)
Time frame: Up to 28 weeks
Depressive symptoms as assessed by the Center for Epidemiological Studies, Depression scale (CES-D)
Time frame: Up to 28 weeks
Stress as assessed by the Impact of Event Scale (IES)
Time frame: Up to 28 weeks
Pain as assessed by the Brief Pain Inventory (BPI)
Time frame: Up to 28 weeks
Fatigue as assessed by the Fatigue Severity Index (FSI)
Time frame: Up to 28 weeks
Diurnal cortisol slope
Study participants will also collect saliva samples at home 4 times a day for 3 days. Saliva samples will be collected at the baseline, mid-treatment, post-treatment and 3-month follow-up assessments. These samples will be used to measure cortisol.
Time frame: Up to 28 weeks
Inflammation
Blood samples will be used to measure levels of inflammatory markers. Blood draws will be coordinated with the participants' regularly scheduled blood draws to minimize discomfort.
Time frame: Up to 28 weeks
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