Biobehavioral Intervention in Gynecologic Oncology Patients
NCT ID: NCT02454036
Last Updated: 2017-12-06
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
PHASE2
6 participants
INTERVENTIONAL
2015-06-30
2017-05-18
Brief Summary
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At the University of Kentucky Markey Cancer Center, BBI treatment is offered in group and individual formats. The course of individual treatment varies and group treatment consists of 10 1.5-hour weekly sessions in the "intensive" phase, followed by 2 1.5-hour bi-weekly maintenance sessions. Individual treatment is one-on-one. In group treatment, there are typically 6-12 patients per group and 1 or 2 therapists. The intervention helps patients to learn adaptive coping strategies and how to apply them to daily stressors. Additional content discusses use of seeking information, enhancing social support, enhancing body esteem and intimacy, and maintaining positive changes.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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BBI Intervention
Biobehavioral Intervention
BBI intervention
Psychological intervention designed to reduce stress and enhance quality of life
Interventions
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BBI intervention
Psychological intervention designed to reduce stress and enhance quality of life
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stage I-IV gynecologic cancer (including ovarian, uterine, cervical, vulvar, or vaginal cancer)
* Undergoing active treatment or in remission and undergoing active surveillance; age ≥21 and ≤80
* Able to speak/read English.
Exclusion Criteria
* Non-English speaking, or significant sensory deficit
* Major mental illness (e.g., schizophrenia, psychotic disorder).
21 Years
80 Years
FEMALE
No
Sponsors
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Rachel Miller
OTHER
Responsible Party
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Rachel Miller
Principal Investigator
Principal Investigators
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Rachel Miller, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky
Locations
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Markey Cancer Center, University of Kentucky
Lexington, Kentucky, United States
Countries
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Other Identifiers
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14-GYN-02-MCC
Identifier Type: -
Identifier Source: org_study_id