Fear of Recurrence and Stopping Immunotherapy

Distress Associated With Stopping Immunotherapy of Cancer Patients

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04761328

Enrollment

100

Registered

2021-02-18

Start date

2021-08-02

Completion date

2028-12-31

Last updated

2025-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Behavioral Therapy

Keywords

Fear of recurrence, Quality of life, Depression, Anxiety

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.

Interventions

BEHAVIORALcognitive behavioral therapy

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Intervention model description

All patients will receive treatment and be evaluated pre- and post-treatment

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Reduce fear of recurrence	3 months	Change by 50%

Secondary

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

Countries

United States

Contacts

Primary ContactJennifer L Steel, Ph.D.

steejl@upmc.edu412-692-2041

Backup ContactJason Luke, MD

lukejj@upmc.edu412-623-4511

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026