Recruiting

Cognitive-Behavioral Therapy

Sponsor:

University of Pittsburgh

Code:

NCT04761328

Conditions

Cognitive Behavioral Therapy

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

cognitive behavioral therapy

Study Details

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.

Conditions

Cognitive Behavioral Therapy

Study ID

NCT04761328

Start date

Aug 2, 2021

Status verified date

Dec, 2025

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Cessation of treatment

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

Interventions

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.

Primary outcome measure

  • Reduce fear of recurrence [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Jennifer L Steel, Ph.D.

412-692-2041steejl@upmc.edu

Jason Luke, MD

412-623-4511lukejj@upmc.edu

Locations

UPMC Hillman Cancer Centers

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Jennifer L Steel, Ph.D.

412-692-2041steejl@upmc.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Dec 5, 2025

Last verified

Dec, 2025

Keywords

  • Fear of recurrence
  • Quality of life
  • Depression
  • Anxiety

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2025-12-05.