Back to resultsFear of Recurrence and Stopping Immunotherapy
Primary Purpose
Cognitive Behavioral Therapy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cognitive behavioral therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Cognitive Behavioral Therapy focused on measuring Fear of recurrence, Quality of life, Depression, Anxiety
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
Sites / Locations
- UPMC Hillman Cancer CentersRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cessation of treatment
Arm Description
If the patient is randomized to this arm, they will be asked to stop their immunotherapy
Outcomes
Primary Outcome Measures
Reduce fear of recurrence
Change by 50%
Secondary Outcome Measures
Improve quality of life
Change of quality of life by 5 points
Reduction of anxiety
Change of anxiety by 2 points
Depressive symptoms
Change by 25%
Full Information
NCT ID
NCT04761328
First Posted
February 16, 2021
Last Updated
October 17, 2023
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT04761328
Brief Title
Fear of Recurrence and Stopping Immunotherapy
Official Title
Distress Associated With Stopping Immunotherapy of Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2021 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
August 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Behavioral Therapy
Keywords
Fear of recurrence, Quality of life, Depression, Anxiety
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All patients will receive treatment and be evaluated pre- and post-treatment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cessation of treatment
Arm Type
Experimental
Arm Description
If the patient is randomized to this arm, they will be asked to stop their immunotherapy
Intervention Type
Behavioral
Intervention Name(s)
cognitive behavioral therapy
Intervention Description
Cognitive-behavioral therapy involves changing these erroneous cognitions and beliefs through cognitive restructuring, modification of behavior, and development of alternative coping skills.
Primary Outcome Measure Information:
Title
Reduce fear of recurrence
Description
Change by 50%
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Improve quality of life
Description
Change of quality of life by 5 points
Time Frame
3 months
Title
Reduction of anxiety
Description
Change of anxiety by 2 points
Time Frame
3 months
Title
Depressive symptoms
Description
Change by 25%
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer L Steel, Ph.D.
Phone
412-692-2041
Email
steejl@upmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jason Luke, MD
Phone
412-623-4511
Email
lukejj@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Luke
Organizational Affiliation
Hillman Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Hillman Cancer Centers
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer L Steel, Ph.D.
Phone
412-692-2041
Email
steejl@upmc.edu
12. IPD Sharing Statement
Learn more about this trial
Fear of Recurrence and Stopping Immunotherapy
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