Clinical trial NCT02454036: Biobehavioral Intervention in Gynecologic Oncology Patients
Official title: Psychological Changes in Cancer Patients Receiving a Biobehavioral Intervention: A Program Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neoplasms
Ovarian Neoplasms
Uterine Neoplasms
Vulva
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2015-05-27
Enrollment: 6
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Emotional distress as measured by Profile of Mood States score
timeFrame: Up to 6 months following completion of treatment
measure: Cancer specific traumatic stress as measured the by Impact of Events Scale score
timeFrame: Up to 6 months following completion of treatment
measure: Social support as measured by the Perceived Social Support from Family score
timeFrame: Up to 6 months following completion of treatment
measure: Physical activity as measured by the Godin-Shepard Leisure-Time Physical Activity Questionnaire score
timeFrame: Up to 6 months following completion of treatment
measure: Dietary habits as measured by the Food Habits Questionnaire
timeFrame: Up to 6 months following completion of treatment
measure: Sexual functioning as measured by the Sexual Experience Scale score
timeFrame: Up to 6 months following completion of treatment
measure: Pain as measured by the Brief Pain Questionnaire score
timeFrame: Up to 6 months following completion of treatment
measure: Fatigue as measured by the Fatigue Severity Index score
timeFrame: Up to 6 months following completion of treatment
measure: Sleep as measured by the Pittsburg Sleep Quality Index
timeFrame: Up to 6 months following completion of treatment
Secondary outcomes:
measure: Patient-reported evaluation of the BBI as measured by the Evaluation of Topics score
timeFrame: Up to 6 months following completion of treatment
measure: Therapist-reported fidelity/Usage of BBI as measured through logs
timeFrame: Up to 6 months following completion of treatment
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Markey Cancer Center, University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Rachel Miller, MD
role: PRINCIPAL_INVESTIGATOR
References: