CancerNCT07886853
Pragmatic Interventions to Advance Cancer Survivor Outcomes
An observational study of Cancer and Malignant Neoplasm, run by University of Texas Southwestern Medical Center.
Trial summary
The goal of this study is to learn how common medical decisions made during routine care-such as medications, exercise recommendations, referrals, and imaging-affect health outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Malignant Neoplasm
- What is being tested?
- Clinical Care decisions
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Nov 2032
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population includes participants that have a diagnosis of any malignant neoplasm and were treated at UTSW Comprehensive Cancer Center cancer clinics, cardio-oncology, or exercise oncology clinics. Receiving care in a participating UTSW cancer clinic or referred to these clinics.
Who may be able to join
- Adult patients (≥18 years).
- Diagnosis of any malignant neoplasm treated at UTSW Comprehensive Cancer Center cancer clinics, cardio-oncology and exercise oncology clinics
- Receiving care in a participating UTSW cancer clinic, or referred to these clinics.
- Able to provide informed consent, unless a waiver of consent is approved for retrospective data collection.
- Unknown/unclear or equivocal difference or lack of guideline in management strategy
Who cannot join
- Individuals unable to provide informed consent for prospective participation, unless a legally authorized representative process is approved.
- Pregnant individuals may be excluded from specific analyses involving procedures not appropriate during pregnancy.
- Patients whose records are subject to legal or institutional restrictions preventing research use.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Intensive vs. Usual Cardiac Care in Patients Receiving Novel Cellular Therapies: the INSPIRE Trial
The goal of this study is to learn how common medical decisions made during routine care-such as medications, exercise recommendations, referrals, and imaging-affect health outcomes.
Read the detailed description
This is a prospective study designed to enable systematic evaluation of real-world interventions in cancer survivor clinics at UT Southwestern Medical Center. The registry will collect longitudinal clinical data and support pragmatic clinical decision-making based on available evidence and expert opinion. Pragmatic interventions may include variations in routine clinical care such as:
- Referral to structured exercise oncology programs versus home-based exercise recommendations
- Cardioprotective medication strategies
- Imaging surveillance approaches
- Cardio-oncology referral timing
- Cardiovascular risk factor optimization strategies These decisions will be made by treating clinicians as part of routine care and captured within the registry for comparative effectiveness evaluation.
- Conditions
- Cancer, Malignant Neoplasm
- Being tested
- Clinical Care decisions
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Care decisionsOther
This registry will support observational comparative effectiveness analyses of pragmatic clinical decisions. Clinical care decisions, including medication use, referral patterns, exercise recommendations, and imaging strategies, will be made by treating clinicians independent of study participation. No investigational drug or device is being tested.
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event occurrence
Occurrence of any grade 2+ adverse event (heart failure, etc.) following cancer diagnosis, as identified through structured data.
Measured: From time of consent up to 12 months
Secondary outcomes (1)
Change in cardiovascular risk factors
To characterize the incidence, timing, and spectrum of cardiovascular events among cancer survivors. To evaluate associations between pragmatic interventions used in routine care and clinical outcomes
Measured: From time of consent up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2032 (estimated)
- Study completion1 Nov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Addison, University of Texas Southwestern Medical Center
- Investigators
- Daniel Addison, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886853
- Sponsor's protocol ID
- STU20260824
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive vs. Usual Cardiac Care in Patients Receiving Novel Cellular Therapies: the INSPIRE Trial
- ClinicalTrials.gov ID
- NCT07886853
- Acronym / sponsor ID
- STU20260824
- Conditions
- Cancer, Malignant Neoplasm
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2032 (estimated)
- Study completion
- 1 Nov 2032 (estimated)
- First posted
- 21 Oct 2026 (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 goal of this study is to learn how common medical decisions made during routine care-such as medications, exercise recommendations, referrals, and imaging-affect health outcomes.
Detailed description
This is a prospective study designed to enable systematic evaluation of real-world interventions in cancer survivor clinics at UT Southwestern Medical Center. The registry will collect longitudinal clinical data and support pragmatic clinical decision-making based on available evidence and expert opinion. Pragmatic interventions may include variations in routine clinical care such as:
- Referral to structured exercise oncology programs versus home-based exercise recommendations
- Cardioprotective medication strategies
- Imaging surveillance approaches
- Cardio-oncology referral timing
- Cardiovascular risk factor optimization strategies These decisions will be made by treating clinicians as part of routine care and captured within the registry for comparative effectiveness evaluation.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population includes participants that have a diagnosis of any malignant neoplasm and were treated at UTSW Comprehensive Cancer Center cancer clinics, cardio-oncology, or exercise oncology clinics. Receiving care in a participating UTSW cancer clinic or referred to these clinics.
Key inclusion criteria (5 listed)
- Adult patients (≥18 years).
- Diagnosis of any malignant neoplasm treated at UTSW Comprehensive Cancer Center cancer clinics, cardio-oncology and exercise oncology clinics
- Receiving care in a participating UTSW cancer clinic, or referred to these clinics.
- Able to provide informed consent, unless a waiver of consent is approved for retrospective data collection.
- Unknown/unclear or equivocal difference or lack of guideline in management strategy
Key exclusion criteria (3 listed)
- Individuals unable to provide informed consent for prospective participation, unless a legally authorized representative process is approved.
- Pregnant individuals may be excluded from specific analyses involving procedures not appropriate during pregnancy.
- Patients whose records are subject to legal or institutional restrictions preventing research use.
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 |
|---|---|---|
| Clinical Care decisionsThis registry will support observational comparative effectiveness analyses of pragmatic clinical decisions. Clinical care decisions, including medication use, referral patterns, exercise recommendations, and imaging strategies, will be made by treating clinicians independent of study participation. No investigational drug or device is being tested. | Other | – |
Primary outcome
Adverse Event occurrence
Time frame: From time of consent up to 12 months
Occurrence of any grade 2+ adverse event (heart failure, etc.) following cancer diagnosis, as identified through structured data.
1 secondary outcome
Change in cardiovascular risk factors
Time frame: From time of consent up to 12 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 21 Oct 2026.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Daniel Addison, MD principal investigator
University of Texas Southwestern Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Malignant Neoplasm, run by University of Texas Southwestern Medical Center.
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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Chinedu Agumadu (214-648-1634, Chinedu.Agumadu@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event occurrence (time frame: From time of consent up to 12 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 21 Oct 2026.