Biobehavioral Intervention in Gynecologic Oncology Patients

Phase 2

Completed

• Conditions: Vulva; Ovarian Neoplasms; Neoplasms; Uterine Neoplasms
• Interventions: Behavioral: BBI intervention

• Registration Number: NCT02454036
• Lead Sponsor: Rachel Miller

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-21
• Study First Submitted QC: 2015-05-26
• Study First Posted: 2015-05-27
• Study Start: 2015-06
• Primary Completion: 2017-05-18
• Study Completion: 2017-05-18
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-04
• Last Update Posted: 2017-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 6

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BBI Intervention	BBI intervention	Biobehavioral Intervention

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Markey Cancer Center, University of Kentucky; 🇺🇸 Lexington, Kentucky, United States