NCT01764789

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Anxiety Disorder
• Depression
• Fatigue
• Leydig Cell Tumor
• Ovarian Sarcoma
• Ovarian Stromal Cancer
• Pain
• Peritoneal Carcinomatosis
• Pseudomyxoma Peritonei
• Recurrent Breast Cancer
• Recurrent Cervical Cancer
• Recurrent Endometrial Carcinoma
• Recurrent Fallopian Tube Cancer
• Recurrent Gestational Trophoblastic Tumor
• Recurrent Ovarian Epithelial Cancer
• Recurrent Ovarian Germ Cell Tumor
• Recurrent Primary Peritoneal Cavity Cancer
• Recurrent Uterine Sarcoma
• Recurrent Vaginal Cancer
• Recurrent Vulvar Cancer

Interventions

Type	Name	Description
OTHER	questionnaire administration	Ancillary studies
PROCEDURE	quality-of-life assessment	Patients will participate in a quality life assessment.
PROCEDURE	psychosocial assessment and care	Participate in multi-component biobehavioral intervention
BEHAVIORAL	behavioral intervention	Participate in multi-component biobehavioral intervention
OTHER	cognitive 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.
OTHER	educational intervention	Participate in multi-component biobehavioral intervention

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2013-01-10
• Last updated: 2015-10-09

Locations

1 site across 1 country: United States