Biobehavioral Intervention in Gynecologic Oncology Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Neoplasms; Uterine Neoplasms; Ovarian Neoplasms; Vulva
• Intervention / Treatment: Behavioral: BBI intervention

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Markey Cancer Center, University of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BBI Intervention; Biobehavioral Intervention	Behavioral: BBI intervention; Psychological intervention designed to reduce stress and enhance quality of life; Other Names: Biobehavioral Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Rachel Miller
• Investigators: Principal Investigator: RACHEL MILLER, MD, University of Kentucky

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): May 18, 2017
• Study Completion (Actual): May 18, 2017

Study Registration Dates

• First Submitted: May 21, 2015
• First Submitted That Met QC Criteria: May 26, 2015
• First Posted (Estimate): May 27, 2015

Study Record Updates

• Last Update Posted (Actual): December 6, 2017
• Last Update Submitted That Met QC Criteria: December 4, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Uterine Diseases; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Neoplasms; Ovarian Neoplasms; Uterine Neoplasms
• Other Study ID Numbers: 14-GYN-02-MCC; R25CA163197 (U.S. NIH Grant/Contract)