Biobehavioral Intervention in Gynecologic Oncology Patients

Study Overview
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Brief Summary
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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.

Official Title
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Psychological Changes in Cancer Patients Receiving a Biobehavioral Intervention: A Program Evaluation

Conditions
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Vulva, Neoplasms, Ovarian Neoplasms, Uterine Neoplasms

Intervention / Treatment
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* Behavioral: BBI intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Concurrent diagnosis of organic brain syndrome, dementia, mental retardation Non-English speaking, or significant sensory deficit Major mental illness (e.g., schizophrenia, psychotic disorder).

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BBI Intervention<br>Biobehavioral Intervention | Behavioral: BBI intervention<br>* Psychological intervention designed to reduce stress and enhance quality of life<br>* Other names: Biobehavioral Intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |