Fear of Recurrence and Stopping Immunotherapy

October 17, 2023 updated by: Jennifer Steel, University of Pittsburgh

Distress Associated With Stopping Immunotherapy of Cancer Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jennifer L Steel, Ph.D.
  • Phone Number: 412-692-2041
  • Email: steejl@upmc.edu

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • UPMC Hillman Cancer Centers
        • Contact:
          • Jennifer L Steel, Ph.D.
          • Phone Number: 412-692-2041
          • Email: steejl@upmc.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cessation of treatment
If the patient is randomized to this arm, they will be asked to stop their immunotherapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduce fear of recurrence
Time Frame: 3 months
Change by 50%
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improve quality of life
Time Frame: 3 months
Change of quality of life by 5 points
3 months
Reduction of anxiety
Time Frame: 3 months
Change of anxiety by 2 points
3 months
Depressive symptoms
Time Frame: 3 months
Change by 25%
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: Jason Luke, Hillman Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2021

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

February 16, 2021

First Submitted That Met QC Criteria

February 16, 2021

First Posted (Actual)

February 18, 2021

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY19110214

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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