Biobehavioral Intervention in Gynecologic Oncology Patients

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02454036
• Other study ID #: 14-GYN-02-MCC
• Secondary ID: R25CA163197
• Status: Completed
• Phase: Phase 2
• First received: May 21, 2015
• Last updated: December 4, 2017
• Start date: June 2015
• Est. completion date: May 18, 2017

Study information

• Verified date: December 2017
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: May 18, 2017
• Est. primary completion date: May 18, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Neoplasms
• Ovarian Neoplasms
• Uterine Neoplasms
• Vulva

Intervention

Behavioral:
• BBI intervention
Psychological intervention designed to reduce stress and enhance quality of life

Locations

Country	Name	City	State
United States	Markey Cancer Center, University of Kentucky	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Rachel Miller

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emotional distress as measured by Profile of Mood States score		Up to 6 months following completion of treatment
Primary	Cancer specific traumatic stress as measured the by Impact of Events Scale score		Up to 6 months following completion of treatment
Primary	Social support as measured by the Perceived Social Support from Family score		Up to 6 months following completion of treatment
Primary	Physical activity as measured by the Godin-Shepard Leisure-Time Physical Activity Questionnaire score		Up to 6 months following completion of treatment
Primary	Dietary habits as measured by the Food Habits Questionnaire		Up to 6 months following completion of treatment
Primary	Sexual functioning as measured by the Sexual Experience Scale score		Up to 6 months following completion of treatment
Primary	Pain as measured by the Brief Pain Questionnaire score		Up to 6 months following completion of treatment
Primary	Fatigue as measured by the Fatigue Severity Index score		Up to 6 months following completion of treatment
Primary	Sleep as measured by the Pittsburg Sleep Quality Index		Up to 6 months following completion of treatment
Secondary	Patient-reported evaluation of the BBI as measured by the Evaluation of Topics score		Up to 6 months following completion of treatment
Secondary	Therapist-reported fidelity/Usage of BBI as measured through logs		Up to 6 months following completion of treatment