Distress and Immunotherapy

Sponsor
University of Pittsburgh (Other)
Overall Status
Recruiting
CT.gov ID
NCT04761328
Collaborator
(none)
100
1
1
60.9
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: cognitive behavioral therapy
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
All patients will receive treatment and be evaluated pre- and post-treatmentAll patients will receive treatment and be evaluated pre- and post-treatment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Distress Associated With Stopping Immunotherapy of Cancer Patients
Actual Study Start Date :
Aug 2, 2021
Anticipated Primary Completion Date :
Aug 31, 2025
Anticipated Study Completion Date :
Aug 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cessation of treatment

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Reduce fear of recurrence [3 months]

    Change by 50%

Secondary Outcome Measures

  1. Improve quality of life [3 months]

    Change of quality of life by 5 points

  2. Reduction of anxiety [3 months]

    Change of anxiety by 2 points

  3. Depressive symptoms [3 months]

    Change by 25%

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UPMC Hillman Cancer Centers Pittsburgh Pennsylvania United States 15213

Sponsors and Collaborators

  • University of Pittsburgh

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jennifer Steel, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT04761328
Other Study ID Numbers:
  • STUDY19110214
First Posted:
Feb 18, 2021
Last Update Posted:
Aug 30, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jennifer Steel, Professor, University of Pittsburgh

Study Results

No Results Posted as of Aug 30, 2021