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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Biobehavioral Intervention for Patients With Gynecologic or Breast Cancer Recurrence

Brief 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 Summary:

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.


Sponsor: Ohio State University Comprehensive Cancer Center

Current Primary Outcome: Quality of life(QoL) [ Time Frame: up to 28 weeks ]

Quality of life as assessed by Short Form (SF)-36


Original Primary Outcome: Quality of life as assessed by Short Form (SF)-36 [ Time Frame: up to 28 weeks ]

Current Secondary Outcome:

  • 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 [ Time Frame: Up to 28 weeks ]
    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.
  • Inflammation [ Time Frame: Up to 28 weeks ]
    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.


Original Secondary Outcome:

  • 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 [ Time Frame: Up to 28 weeks ]
  • Inflammation [ Time Frame: Up to 28 weeks ]


Information By: Ohio State University Comprehensive Cancer Center

Dates:
Date Received: January 8, 2013
Date Started: October 2010
Date Completion:
Last Updated: October 8, 2015
Last Verified: October 2015