Fear of Recurrence and Stopping Immunotherapy | NCT04761328

Studies
Fear of Recurrence and Stopping Immunotherapy

NCT04761328

Sponsor

University of Pittsburgh

Status

Recruiting

Last Update Posted

Dec 5, 2025Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Cognitive Behavioral Therapy

Interventions

cognitive behavioral therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2, 2021Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Feb 16, 2021

First Submission Date that Met QC Criteria

Feb 16, 2021

First Posted Date

Feb 18, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2025

Last Update Posted Date

Dec 5, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cessation of treatment	Experimental	If the patient is randomized to this arm, they will be asked to stop their immunotherapy	Behavioral: cognitive behavioral therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cognitive behavioral therapy	Behavioral	Cognitive-behavioral therapy involves changing these erroneous cognitions and beliefs through cognitive restructuring, modification of behavior, and development of alternative coping skills.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Improve quality of life	Change of quality of life by 5 points	3 months
Reduction of anxiety	Change of anxiety by 2 points	3 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jennifer L Steel, Ph.D.	Contact	412-692-2041		steejl@upmc.edu
Jason Luke, MD	Contact	412-623-4511		lukejj@upmc.edu

Overall Officials

Name	Affiliation	Role
Jason Luke	Hillman Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UPMC Hillman Cancer Centers	Recruiting	Pittsburgh	Pennsylvania	15213	United States

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression
D001008	Anxiety Disorders

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015928	Cognitive Behavioral Therapy

Ancestor Terms

ID	Term
D001521	Behavior Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided