Fear of Recurrence and Stopping Immunotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: cognitive behavioral therapy.
- Who it may be relevant to
- Registry conditions: Cognitive Behavioral Therapy. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Distress Associated With Stopping Immunotherapy of Cancer Patients
Overview
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.
Interventions
- Behavioral cognitive behavioral therapy
Cognitive-behavioral therapy involves changing these erroneous cognitions and beliefs through cognitive restructuring, modification of behavior, and development of alternative coping skills.
Primary outcome measures
- Reduce fear of recurrence [Time frame: 3 months]
Secondary outcome measures (3)
- Improve quality of life [Time frame: 3 months]
- Reduction of anxiety [Time frame: 3 months]
- Depressive symptoms [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- Age 21 years and older
- Fluent in English
- Diagnosis of cancer and history of treatment with immunotherapy
Exclusion criteria
- Active suicidal ideation, delusions or hallucinations
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- UPMC Hillman Cancer Centers — Pittsburgh
Identifiers
NCT: NCT04761328 · STUDY19110214