Biobehavioral Intervention in Gynecologic Oncology Patients

NCT02454036CompletedPHASE2INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Rachel Miller

Enrollment

6

Start Date

2015-06-01

Completion Date

2017-05-18

Study Type

INTERVENTIONAL

Official Title

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

Interventions

BBI intervention

Conditions

NeoplasmsOvarian NeoplasmsUterine NeoplasmsVulva

Eligibility

Age Range

21 Years – 80 Years

Sex

FEMALE

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).

Outcome Measures

Primary Outcomes

Emotional distress as measured by Profile of Mood States score

Time frame: Up to 6 months following completion of treatment

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

Time frame: Up to 6 months following completion of treatment

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

Time frame: Up to 6 months following completion of treatment

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

Time frame: Up to 6 months following completion of treatment

Dietary habits as measured by the Food Habits Questionnaire

Time frame: Up to 6 months following completion of treatment

Sexual functioning as measured by the Sexual Experience Scale score

Time frame: Up to 6 months following completion of treatment

Pain as measured by the Brief Pain Questionnaire score

Time frame: Up to 6 months following completion of treatment

Fatigue as measured by the Fatigue Severity Index score

Time frame: Up to 6 months following completion of treatment

Sleep as measured by the Pittsburg Sleep Quality Index

Time frame: Up to 6 months following completion of treatment

Secondary Outcomes

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

Time frame: Up to 6 months following completion of treatment

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

Time frame: Up to 6 months following completion of treatment

Locations

Markey Cancer Center, University of Kentucky, Lexington, United States