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Biobehavioral Intervention in Gynecologic Oncology Patients

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ClinicalTrials.gov Identifier: NCT02454036
Recruitment Status : Completed
First Posted : May 27, 2015
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
Rachel Miller, University of Kentucky

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.


Condition or disease Intervention/treatment Phase
Neoplasms Ovarian Neoplasms Uterine Neoplasms Vulva Behavioral: BBI intervention Phase 2

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Study Type : Interventional
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Psychological Changes in Cancer Patients Receiving a Biobehavioral Intervention: A Program Evaluation
Study Start Date : June 2015
Actual Primary Completion Date : May 18, 2017
Actual Study Completion Date : May 18, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BBI Intervention
Biobehavioral Intervention
Behavioral: BBI intervention
Psychological intervention designed to reduce stress and enhance quality of life
Other Name: Biobehavioral Intervention




Primary Outcome Measures :
  1. Emotional distress as measured by Profile of Mood States score [ Time Frame: Up to 6 months following completion of treatment ]
  2. Cancer specific traumatic stress as measured the by Impact of Events Scale score [ Time Frame: Up to 6 months following completion of treatment ]
  3. Social support as measured by the Perceived Social Support from Family score [ Time Frame: Up to 6 months following completion of treatment ]
  4. Physical activity as measured by the Godin-Shepard Leisure-Time Physical Activity Questionnaire score [ Time Frame: Up to 6 months following completion of treatment ]
  5. Dietary habits as measured by the Food Habits Questionnaire [ Time Frame: Up to 6 months following completion of treatment ]
  6. Sexual functioning as measured by the Sexual Experience Scale score [ Time Frame: Up to 6 months following completion of treatment ]
  7. Pain as measured by the Brief Pain Questionnaire score [ Time Frame: Up to 6 months following completion of treatment ]
  8. Fatigue as measured by the Fatigue Severity Index score [ Time Frame: Up to 6 months following completion of treatment ]
  9. Sleep as measured by the Pittsburg Sleep Quality Index [ Time Frame: Up to 6 months following completion of treatment ]

Secondary Outcome Measures :
  1. Patient-reported evaluation of the BBI as measured by the Evaluation of Topics score [ Time Frame: Up to 6 months following completion of treatment ]
  2. Therapist-reported fidelity/Usage of BBI as measured through logs [ Time Frame: Up to 6 months following completion of treatment ]


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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454036


Locations
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United States, Kentucky
Markey Cancer Center, University of Kentucky
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
Rachel Miller
Investigators
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Principal Investigator: Rachel Miller, MD University of Kentucky

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Responsible Party: Rachel Miller, Principal Investigator, University of Kentucky
ClinicalTrials.gov Identifier: NCT02454036     History of Changes
Other Study ID Numbers: 14-GYN-02-MCC
R25CA163197 ( U.S. NIH Grant/Contract )
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
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Neoplasms
Ovarian Neoplasms
Uterine Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Uterine Diseases