Pragmatic Interventions to Advance Cancer Survivor Outcomes

NCT07886853 — Not yet recruiting, 10000 participants, University of Texas Southwestern Medical Center

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Intensive vs. Usual Cardiac Care in Patients Receiving Novel Cellular Therapies: the INSPIRE Trial

Registry	NCT07886853
Status	Not yet recruiting
Study type	Observational
Enrollment	10000 (Estimated)
Sponsor	University of Texas Southwestern Medical Center (Other)
Conditions	Cancer, Malignant Neoplasm
Interventions	Clinical Care decisions (Other)
Dates	start 2026-11-01 (estimated), primary completion 2032-11-01 (estimated), completion 2032-11-01 (estimated), first posted 2026-10-21, last updated 2026-10-21

-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.

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+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.

+Arms and interventions

Clinical Care decisions (Other): 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.

+Outcome measures

Primary outcomes

Adverse Event occurrence [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.

Secondary outcomes

Change in cardiovascular risk factors [From time of consent up to 12 months]: 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

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

+Investigators

Daniel Addison, MD, Principal investigator, University of Texas Southwestern Medical Center