Fear of Recurrence and Stopping Immunotherapy
- Conditions
- Cognitive Behavioral Therapy
- Interventions
- Behavioral: cognitive behavioral therapy
- Registration Number
- NCT04761328
- Lead Sponsor
- University of Pittsburgh
- Brief Summary
The study includes participants experiencing distress with regard to stopping immunotherapy and will utilize cognitive-behavioral therapy to reduce fear of recurrence, depression, and anxiety and improve quality of life.
- Detailed Description
The intervention will be delivered through telemedicine to reduce the patient-related barriers to treatment including cost, transportation, and being able to maintain appointments while managing the side effects of treatment. The intervention will provide the patient with skills to reduce distress associated with ceasing treatment of a checkpoint inhibitor through the development evidence-based psychological and behavioral strategies that are tailored to the patients' preferences.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Age 21 years and older
- Fluent in English
- Diagnosis of cancer and history of treatment with immunotherapy
- Active suicidal ideation, delusions or hallucinations
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cessation of treatment cognitive behavioral therapy If the patient is randomized to this arm, they will be asked to stop their immunotherapy
- Primary Outcome Measures
Name Time Method Reduce fear of recurrence 3 months Change by 50%
- Secondary Outcome Measures
Name Time Method Improve quality of life 3 months Change of quality of life by 5 points
Depressive symptoms 3 months Change by 25%
Reduction of anxiety 3 months Change of anxiety by 2 points
Trial Locations
- Locations (1)
UPMC Hillman Cancer Centers
🇺🇸Pittsburgh, Pennsylvania, United States