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Cognitive Behavioral Therapy for Fear of Recurrence

N/A
Recruiting
Led By Jason Luke
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 21 years and older
Diagnosis of cancer and history of treatment with immunotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This trial will study whether cognitive-behavioral therapy can help reduce fear, depression, and anxiety in people who are experiencing distress about stopping immunotherapy.

Who is the study for?
This trial is for English-speaking adults aged 21 or older who have been treated with immunotherapy for cancer and are now dealing with distress about stopping the treatment. It's not suitable for individuals experiencing delusions, hallucinations, or active thoughts of suicide.Check my eligibility
What is being tested?
The study tests whether cognitive behavioral therapy can help reduce fear of cancer recurrence, depression, anxiety, and improve overall quality of life after patients stop their immunotherapy treatments.See study design
What are the potential side effects?
Since this trial involves cognitive behavioral therapy—a form of talk therapy—there are no direct physical side effects like you'd expect from medication. However, discussing emotional topics may be challenging or uncomfortable.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 21 years old or older.
Select...
I have cancer and have been treated with immunotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Reduce fear of recurrence
Secondary outcome measures
Depressive symptoms
Improve quality of life
Reduction of anxiety

Side effects data

From 2015 Phase 2 trial • 142 Patients • NCT00964886
29%
dry mouth
24%
constipation
24%
difficulty urinating
18%
erectile dysfunction
12%
ejaculatory dysfunction
12%
accomodation disturbance
12%
orgasm dysfunction
6%
decreased libido
6%
increased dreaming
6%
muscle rigidity
6%
photosensitivity
6%
insomnia
6%
diaphoresis
3%
urosepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 1
Arm 3
Arm 2
Arm 4

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cessation of treatmentExperimental Treatment1 Intervention
If the patient is randomized to this arm, they will be asked to stop their immunotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
cognitive behavioral therapy
2010
Completed Phase 2
~930

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,722 Previous Clinical Trials
16,342,846 Total Patients Enrolled
Jason LukePrincipal InvestigatorHillman Cancer Center
1 Previous Clinical Trials
5 Total Patients Enrolled

Media Library

Cognitive Behavioral Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04761328 — N/A
Cognitive Behavioral Therapy Research Study Groups: Cessation of treatment
Cognitive Behavioral Therapy Clinical Trial 2023: Cognitive Behavioral Therapy Highlights & Side Effects. Trial Name: NCT04761328 — N/A
Cognitive Behavioral Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04761328 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are medical professionals currently enrolling subjects for this research experiment?

"According to the official clinicaltrials.gov website, this trial is still open for enrolment. It was first uploaded on August 2nd 2021 and last modified on October 12th 2022."

Answered by AI

How many participants have been allowed to join this clinical investigation?

"Affirmative, the information available on clinicaltrials.gov states that this research is presently enlisting volunteers. The trial was published on August 2nd 2021 and has been updated as of October 12th 2022. A total of 100 participants are desired to be recruited from 1 site."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
What site did they apply to?
UPMC Hillman Cancer Centers
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Fear of Recurrence and Stopping Immunotherapy
Jennifer Steel 2021. "Fear of Recurrence and Stopping Immunotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04761328.
~33 spots leftby Aug 2025
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