Stress Reduction in Improving Quality of Life in Patients With Recurrent Gynecologic or Breast Cancer
NCT ID: NCT01764789
Last Updated: 2015-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
39 participants
INTERVENTIONAL
2010-10-31
2012-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Supportive care (psychosocial intervention)
Patients 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.
questionnaire administration
Ancillary studies
quality-of-life assessment
Patients will participate in a quality life assessment.
psychosocial assessment and care
Participate in multi-component biobehavioral intervention
behavioral intervention
Participate in multi-component biobehavioral intervention
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.
educational intervention
Participate in multi-component biobehavioral intervention
Interventions
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questionnaire administration
Ancillary studies
quality-of-life assessment
Patients will participate in a quality life assessment.
psychosocial assessment and care
Participate in multi-component biobehavioral intervention
behavioral intervention
Participate in multi-component biobehavioral intervention
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.
educational intervention
Participate in multi-component biobehavioral intervention
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
21 Years
85 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Barbara Andersen
Principal Investigator
Principal Investigators
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Barbara Andersen, PhD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Ohio State University Medical Center
Columbus, Ohio, United States
Countries
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Related Links
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The Jamesline
Other Identifiers
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NCI-2012-01177
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-10026
Identifier Type: -
Identifier Source: org_study_id
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