Cognitive Behavioral TherapyNCT04761328
Fear of Recurrence and Stopping Immunotherapy
A study testing cognitive behavioral therapy in people with Cognitive Behavioral Therapy, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cognitive Behavioral Therapy
- What is being tested?
- cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2021to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 years and older
- Fluent in English
- Diagnosis of cancer and history of treatment with immunotherapy
Who cannot join
- Active suicidal ideation, delusions or hallucinations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UPMC Hillman Cancer Centers
Pittsburgh, Pennsylvania, 15213
Jennifer L Steel, Ph.D., 412-692-2041, steejl@upmc.edu
About this study
Official title: Distress Associated With Stopping Immunotherapy of Cancer Patients
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.
Read the 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.
- Conditions
- Cognitive Behavioral Therapy
- Being tested
- cognitive behavioral therapy
- Keywords
- Fear of recurrence, Quality of life, Depression, Anxiety
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavioral therapyBehavioural
Cognitive-behavioral therapy involves changing these erroneous cognitions and beliefs through cognitive restructuring, modification of behavior, and development of alternative coping skills.
| Study group | Role | What they receive |
|---|---|---|
| Cessation of treatment | Experimental | If the patient is randomized to this arm, they will be asked to stop their immunotherapy Receives: Behavioral: cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduce fear of recurrence
Change by 50%
Measured: 3 months
Secondary outcomes (3)
Improve quality of life
Change of quality of life by 5 points
Measured: 3 months
Reduction of anxiety
Change of anxiety by 2 points
Measured: 3 months
Depressive symptoms
Change by 25%
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start2 Aug 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Behavioral TherapyStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients will receive treatment and be evaluated pre- and post-treatment
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Steel, University of Pittsburgh
- Investigators
- Jason Luke, Principal investigator, Hillman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761328
- Sponsor's protocol ID
- STUDY19110214
- Status last verified
- Dec 2025
- First submitted
- 16 Feb 2021
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distress Associated With Stopping Immunotherapy of Cancer Patients
- ClinicalTrials.gov ID
- NCT04761328
- Acronym / sponsor ID
- STUDY19110214
- Conditions
- Cognitive Behavioral Therapy
- Keywords
- Fear of recurrence, Quality of life, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients will receive treatment and be evaluated pre- and post-treatment
| Arm | Type | Receives |
|---|---|---|
| Cessation of treatment | Experimental | Behavioral: cognitive behavioral therapyIf the patient is randomized to this arm, they will be asked to stop their immunotherapy |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 21 years and older
- Fluent in English
- Diagnosis of cancer and history of treatment with immunotherapy
Key exclusion criteria (1 listed)
- Active suicidal ideation, delusions or hallucinations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive behavioral therapyCognitive-behavioral therapy involves changing these erroneous cognitions and beliefs through cognitive restructuring, modification of behavior, and development of alternative coping skills. | Behavioural | Cessation of treatment |
Primary outcome
Reduce fear of recurrence
Time frame: 3 months
Change by 50%
3 secondary outcomes
Improve quality of life
Time frame: 3 months
Reduction of anxiety
Time frame: 3 months
Depressive symptoms
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason Luke principal investigator
Hillman Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive behavioral therapy in people with Cognitive Behavioral Therapy, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer L Steel, Ph.D. (412-692-2041, steejl@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduce fear of recurrence (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.