Clinical trial · Interventional
Biobehavioral Intervention in Gynecologic Oncology Patients
Psychological Changes in Cancer Patients Receiving a Biobehavioral Intervention: A Program Evaluation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Uterine Neoplasms | Uterine Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Vulva | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BBI intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BBI Intervention
- description
- Biobehavioral Intervention
- interventionNames
- Behavioral: BBI intervention
Primary outcomes (9)
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available