NCT04761328

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
32mo left

Started Aug 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Aug 2021Dec 2028

First Submitted

Initial submission to the registry

February 16, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

August 2, 2021

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

December 5, 2025

Status Verified

December 1, 2025

Enrollment Period

6.4 years

First QC Date

February 16, 2021

Last Update Submit

December 1, 2025

Conditions

Cognitive Behavioral Therapy

Keywords

Fear of recurrenceQuality of lifeDepressionAnxiety

Outcome Measures

Primary Outcomes (1)

  • Reduce fear of recurrence

    Change by 50%

    3 months

Secondary Outcomes (3)

  • Improve quality of life

    3 months

  • Reduction of anxiety

    3 months

  • Depressive symptoms

    3 months

Study Arms (1)

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

cognitive behavioral therapyBEHAVIORAL

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

Cessation of treatment

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 21 years and older
  • Fluent in English
  • Diagnosis of cancer and history of treatment with immunotherapy

You may not qualify if:

  • Active suicidal ideation, delusions or hallucinations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC Hillman Cancer Centers

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

DepressionAnxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jason Luke

    Hillman Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer L Steel, Ph.D.

CONTACT

412-692-2041steejl@upmc.edu

Jason Luke, MD

CONTACT

412-623-4511lukejj@upmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: All patients will receive treatment and be evaluated pre- and post-treatment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 16, 2021

First Posted

February 18, 2021

Study Start

August 2, 2021

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

December 5, 2025

Record last verified: 2025-12

Locations

US(1)