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Biobehavioral Intervention in Gynecologic Oncology Patients

R

Rachel Miller

Status and phase

Completed
Phase 2

Conditions

Ovarian Neoplasms
Uterine Neoplasms
Vulva
Neoplasms

Treatments

Behavioral: BBI intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT02454036
14-GYN-02-MCC
R25CA163197 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

Female

Ages

21 to 80 years old

Volunteers

No 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).

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 1 patient group

BBI Intervention
Experimental group
Description:
Biobehavioral Intervention
Treatment:
Behavioral: BBI intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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