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NCT04761328 Clinical Trial

Fear of Recurrence and Stopping Immunotherapy

Cognitive Behavioral Therapy Clinical Trial

Official title:
Distress Associated With Stopping Immunotherapy of Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04761328
Other study ID # STUDY19110214
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 2, 2021
Est. completion date August 31, 2026

Study information
Verified date October 2023
Source University of Pittsburgh
Contact Jennifer L Steel, Ph.D.
Phone 412-692-2041
Email steejl@upmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Recruiting
Enrollment 100
Est. completion date August 31, 2026
Est. primary completion date August 31, 2025
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States UPMC Hillman Cancer Centers Pittsburgh Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reduce fear of recurrence Change by 50% 3 months
Secondary Improve quality of life Change of quality of life by 5 points 3 months
Secondary Reduction of anxiety Change of anxiety by 2 points 3 months
Secondary Depressive symptoms Change by 25% 3 months
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