Biobehavioral Intervention in Gynecologic Oncology Patients
Completed · Phase 2
Conditions studied: Neoplasms, Ovarian Neoplasms, Uterine Neoplasms, Vulva
In brief
Baseline self-report outcome measures will be completed and additional assessments will occur mid-treatment , post-treatment , 3 months following completion of all sessions, and 6 months following completion of all sessions. Patients and therapists will complete the evaluation measures in private (at home, in an office). 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.
Key facts
- Study ID
- NCT02454036
- Run by
- Rachel Miller
- People needed
- 6
- Starts
- 2015-06-01
- Expected to finish
- 2017-05-18
- Last updated by the study team
- 2017-12-06
Who can join
Age: 21 and older, up to 80. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Females
- 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.
You may not qualify if…
- Concurrent diagnosis of organic brain syndrome, dementia, mental retardation
- Non-English speaking, or significant sensory deficit
- Major mental illness (e.g., schizophrenia, psychotic disorder).
Where it is running
- Markey Cancer Center, University of Kentucky — Lexington, Kentucky, United States
Full record on ClinicalTrials.gov
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