NCT02454036

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2017

Completed
Last Updated

December 6, 2017

Status Verified

December 1, 2017

Enrollment Period

2 years

First QC Date

May 21, 2015

Last Update Submit

December 4, 2017

Conditions

NeoplasmsOvarian NeoplasmsUterine NeoplasmsVulva

Outcome Measures

Primary Outcomes (9)

  • 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 Outcomes (2)

  • 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

Study Arms (1)

BBI Intervention

EXPERIMENTAL

Biobehavioral Intervention

Behavioral: BBI intervention

Interventions

BBI interventionBEHAVIORAL

Psychological intervention designed to reduce stress and enhance quality of life

Also known as: Biobehavioral Intervention
BBI Intervention

Eligibility Criteria

Age21 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Markey Cancer Center, University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

NeoplasmsOvarian NeoplasmsUterine Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersUterine Diseases

Study Officials

  • Rachel Miller, MD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 21, 2015

First Posted

May 27, 2015

Study Start

June 1, 2015

Primary Completion

May 18, 2017

Study Completion

May 18, 2017

Last Updated

December 6, 2017

Record last verified: 2017-12

Locations

US(1)