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NCT Number: NCT04761328

Fear of Recurrence and Stopping Immunotherapy

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.

Recruiting

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Key information

Conditions

Cognitive Behavioral Therapy Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Hillman Cancer Centers

Pittsburgh, Pennsylvania, 15213, United States

Location status: Recruiting

Location contact

Jennifer L Steel, Ph.D.

CONTACT

[email protected]

412-692-2041

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Reduce fear of recurrence

    Time frame: 3 months

    Change by 50%

Secondary outcomes

  1. Improve quality of life

    Time frame: 3 months

    Change of quality of life by 5 points

  2. Reduction of anxiety

    Time frame: 3 months

    Change of anxiety by 2 points

  3. Depressive symptoms

    Time frame: 3 months

    Change by 25%

Study contacts

Contact information is provided by the study sponsor or research team.

Jason Luke, MD

CONTACT

[email protected]

412-623-4511

Jennifer L Steel, Ph.D.

CONTACT

[email protected]

412-692-2041

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

Distress Associated With Stopping Immunotherapy of Cancer Patients

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
Feb 18, 2021
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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