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
3 other identifiers
interventional
39
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 8, 2013
CompletedFirst Posted
Study publicly available on registry
January 10, 2013
CompletedOctober 9, 2015
October 1, 2015
1.3 years
January 8, 2013
October 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of life(QoL)
Quality of life as assessed by Short Form (SF)-36
up to 28 weeks
Secondary Outcomes (7)
Mood as assessed by the Profile of Mood States (POMS)
Up to 28 weeks
Depressive symptoms as assessed by the Center for Epidemiological Studies, Depression scale (CES-D)
Up to 28 weeks
Stress as assessed by the Impact of Event Scale (IES)
Up to 28 weeks
Pain as assessed by the Brief Pain Inventory (BPI)
Up to 28 weeks
Fatigue as assessed by the Fatigue Severity Index (FSI)
Up to 28 weeks
- +2 more secondary outcomes
Study Arms (1)
Supportive care (psychosocial intervention)
EXPERIMENTALPatients participate in a multi-component intervention based on cognitive and behavioral principles comprising 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- Diagnosis of recurrent breast or gynecologic cancer (any site) with any disease-free interval; second primary cancers do not meet this criterion
- English speaking
- Able and willing to give informed consent
- To be considered for the blood and saliva collection, women must fulfill the following secondary criteria:
- Diagnosis of recurrent breast or ovarian cancer with any disease-free interval
You may not qualify if:
- Residence \> 70 miles from research site
- Subnormal intellectual potential (diagnosis of mental retardation)
- Progressive neurological or chronic, progressive, debilitating condition (e.g., dementia)
- Non-ambulatory
- Life expectancy less than 160 days, per the treating oncologist
- Current suicide risk sufficient to preclude treatment on an outpatient basis
- Chronic inflammatory or autoimmune disorder (e.g., rheumatoid arthritis, lupus)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara Andersen, PhD
Ohio State University Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 8, 2013
First Posted
January 10, 2013
Study Start
October 1, 2010
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
October 9, 2015
Record last verified: 2015-10