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| ID | Type | Description | Link |
|---|---|---|---|
| R25CA163197 | U.S. NIH Grant/Contract | View source |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BBI Intervention | Experimental | Biobehavioral Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BBI intervention | Behavioral | Psychological intervention designed to reduce stress and enhance quality of life |
|
| Measure | Description | Time Frame |
|---|---|---|
| Emotional distress as measured by Profile of Mood States score | Up to 6 months following completion of treatment | |
| Cancer specific traumatic stress as measured the by Impact of Events Scale score | Up to 6 months following completion of treatment | |
| Social support as measured by the Perceived Social Support from Family score | Up to 6 months following completion of treatment | |
| Physical activity as measured by the Godin-Shepard Leisure-Time Physical Activity Questionnaire score | Up to 6 months following completion of treatment | |
| Dietary habits as measured by the Food Habits Questionnaire | Up to 6 months following completion of treatment | |
| Sexual functioning as measured by the Sexual Experience Scale score | Up to 6 months following completion of treatment | |
| Pain as measured by the Brief Pain Questionnaire score | Up to 6 months following completion of treatment | |
| Fatigue as measured by the Fatigue Severity Index score | Up to 6 months following completion of treatment | |
| Sleep as measured by the Pittsburg Sleep Quality Index | Up to 6 months following completion of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported evaluation of the BBI as measured by the Evaluation of Topics score | Up to 6 months following completion of treatment | |
| Therapist-reported fidelity/Usage of BBI as measured through logs | Up to 6 months following completion of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Miller, MD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Markey Cancer Center, University of Kentucky | Lexington | Kentucky | 40536 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D010051 | Ovarian Neoplasms |
| D014594 | Uterine Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
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| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014591 | Uterine Diseases |