Fear of Recurrence and Stopping Immunotherapy

NCT ID: NCT04761328

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-02

Study Completion Date

2028-12-31

Brief Summary

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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

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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.

Conditions

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Cognitive Behavioral Therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All patients will receive treatment and be evaluated pre- and post-treatment
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Cessation of treatment

If the patient is randomized to this arm, they will be asked to stop their immunotherapy

Group Type EXPERIMENTAL

cognitive behavioral therapy

Intervention Type BEHAVIORAL

Cognitive-behavioral therapy involves changing these erroneous cognitions and beliefs through cognitive restructuring, modification of behavior, and development of alternative coping skills.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Steel

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jason Luke

Role: PRINCIPAL_INVESTIGATOR

Hillman Cancer Center

Locations

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UPMC Hillman Cancer Centers

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jennifer L Steel, Ph.D.

Role: CONTACT

412-692-2041

Jason Luke, MD

Role: CONTACT

412-623-4511

Facility Contacts

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Jennifer L Steel, Ph.D.

Role: primary

412-692-2041

Other Identifiers

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STUDY19110214

Identifier Type: -

Identifier Source: org_study_id

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