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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms

  • Anxiety Disorder
  • Anxiety Disorders
  • Breast Neoplasms
  • Depression
  • Endometrial Neoplasms
  • Fatigue
  • Germinoma
  • Gestational Trophoblastic Disease
  • Leydig Cell Tumor
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms
  • Ovarian Sarcoma
  • Ovarian Stromal Cancer
  • Pain
  • Peritoneal Carcinomatosis
  • Peritoneal Neoplasms
  • 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
  • Sarcoma
  • Trophoblastic Neoplasms
  • Uterine Cervical Neoplasms
  • Vaginal Neoplasms
  • Vulvar Neoplasms

NCT number NCT01764789
Study type Interventional
Source Ohio State University Comprehensive Cancer Center
Contact
Status Completed
Phase N/A
Start date October 2010
Completion date January 2012

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