Fear of Recurrence and Stopping Immunotherapy

University of Pittsburgh

Status: Enrolling

Conditions: Cognitive Behavioral Therapy

Treatments: Behavioral: cognitive behavioral therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04761328

STUDY19110214

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Cessation of treatment

Experimental group

Description:

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

Treatment:

Behavioral: cognitive behavioral therapy