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Biobehavioral Intervention in Gynecologic Oncology Patients

Sponsor
Rachel Miller (Other)
Overall Status
Completed
CT.gov ID
NCT02454036
Collaborator
(none)
6
Enrollment
1
Location
1
Arm
23.6
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: BBI intervention
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Psychological Changes in Cancer Patients Receiving a Biobehavioral Intervention: A Program Evaluation
Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
May 18, 2017
Actual Study Completion Date :
May 18, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Emotional distress as measured by Profile of Mood States score [Up to 6 months following completion of treatment]

    2. Cancer specific traumatic stress as measured the by Impact of Events Scale score [Up to 6 months following completion of treatment]

    3. Social support as measured by the Perceived Social Support from Family score [Up to 6 months following completion of treatment]

    4. Physical activity as measured by the Godin-Shepard Leisure-Time Physical Activity Questionnaire score [Up to 6 months following completion of treatment]

    5. Dietary habits as measured by the Food Habits Questionnaire [Up to 6 months following completion of treatment]

    6. Sexual functioning as measured by the Sexual Experience Scale score [Up to 6 months following completion of treatment]

    7. Pain as measured by the Brief Pain Questionnaire score [Up to 6 months following completion of treatment]

    8. Fatigue as measured by the Fatigue Severity Index score [Up to 6 months following completion of treatment]

    9. Sleep as measured by the Pittsburg Sleep Quality Index [Up to 6 months following completion of treatment]

    Secondary Outcome Measures

    1. Patient-reported evaluation of the BBI as measured by the Evaluation of Topics score [Up to 6 months following completion of treatment]

    2. Therapist-reported fidelity/Usage of BBI as measured through logs [Up to 6 months following completion of treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 80 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Markey Cancer Center, University of Kentucky Lexington Kentucky United States 40536

    Sponsors and Collaborators

    • Rachel Miller

    Investigators

    • Principal Investigator: Rachel Miller, MD, University of Kentucky

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rachel Miller, Principal Investigator, University of Kentucky
    ClinicalTrials.gov Identifier:
    NCT02454036
    Other Study ID Numbers:
    • 14-GYN-02-MCC
    • R25CA163197
    First Posted:
    May 27, 2015
    Last Update Posted:
    Dec 6, 2017
    Last Verified:
    Dec 1, 2017
    Additional relevant MeSH terms:
    Neoplasms
    Ovarian Neoplasms
    Uterine Neoplasms

    Study Results

    No Results Posted as of Dec 6, 2017