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Completed

NCT Number: NCT02454036

Biobehavioral Intervention in Gynecologic Oncology Patients

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.

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Key information

Conditions

Neoplasms Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms Vulva

Age range

21 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Markey Cancer Center, University of Kentucky

Lexington, Kentucky, 40536, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

BBI intervention

Behavioral

Psychological intervention designed to reduce stress and enhance quality of life

Other names: Biobehavioral Intervention

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Rachel Miller

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 27, 2015
Registry last updated
Dec 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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