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Biobehavioral Intervention in Gynecologic Oncology Patients

Primary Purpose

Neoplasms, Ovarian Neoplasms, Uterine Neoplasms

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

BBI intervention

About this trial

This is an interventional supportive care trial for Neoplasms

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

Markey Cancer Center, University of Kentucky

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BBI Intervention

Arm Description

Biobehavioral Intervention

Outcomes

Primary Outcome Measures

Emotional distress as measured by Profile of Mood States score

Cancer specific traumatic stress as measured the by Impact of Events Scale score

Social support as measured by the Perceived Social Support from Family score

Physical activity as measured by the Godin-Shepard Leisure-Time Physical Activity Questionnaire score

Dietary habits as measured by the Food Habits Questionnaire

Sexual functioning as measured by the Sexual Experience Scale score

Pain as measured by the Brief Pain Questionnaire score

Fatigue as measured by the Fatigue Severity Index score

Sleep as measured by the Pittsburg Sleep Quality Index

Secondary Outcome Measures

Patient-reported evaluation of the BBI as measured by the Evaluation of Topics score

Therapist-reported fidelity/Usage of BBI as measured through logs

Full Information

NCT ID

NCT02454036

First Posted

May 21, 2015

Last Updated

December 4, 2017

Sponsor

Rachel Miller

1. Study Identification

Unique Protocol Identification Number

NCT02454036

Brief Title

Biobehavioral Intervention in Gynecologic Oncology Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

June 2015 (undefined)

Primary Completion Date

May 18, 2017 (Actual)

Study Completion Date

May 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Rachel Miller

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neoplasms, Ovarian Neoplasms, Uterine Neoplasms, Vulva

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BBI Intervention

Arm Type

Experimental

Arm Description

Biobehavioral Intervention

Intervention Type

Behavioral

Intervention Name(s)

BBI intervention

Other Intervention Name(s)

Biobehavioral Intervention

Intervention Description

Psychological intervention designed to reduce stress and enhance quality of life

Primary Outcome Measure Information:

Title

Emotional distress as measured by Profile of Mood States score

Time Frame