Study of Peripheral Arterial Disease (PAD) in People With Cancer Who Will Be Having Surgery

Study Overview
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Brief Summary
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Researchers are studying whether people with risk factors for blood circulation disease have a condition called peripheral arterial disease (PAD). People with PAD have poor blood circulation because of narrowing or blocks in blood vessels caused by fat or calcium deposits (atherosclerosis). The study researchers think that PAD may lead to worse outcomes in cancer treatment, but people with cancer are not routinely tested for the disease. The purpose of this study is to find out how common PAD is among people with cancer who have risk factors for blood circulation disease, and to compare how often PAD is diagnosed in different racial groups

Official Title
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Impact and Prevalence of PAD on Cancer Patients at High-risk for PAD Going to Surgery

Conditions
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Peripheral Arterial Disease (PAD) in Cancer Patients

Intervention / Treatment
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* Diagnostic Test: ABI/TBI
* Other: Questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cancer patients who are ≥ 65 years old Either diabetes (on medication or insulin) or smoking history (current smoker, smoking within the last 15 years, ≥ 20 pack years) Patients who are scheduled for major head and neck, thoracic, abdominal, or pelvic surgery requiring at least a 2-day admission Ambulatory ≥ 6 month life expectancy as determined based on clinical judgement by the treating physician. If treating clinician does not confirm life-expectancy ≥ 6 months, will calculate Lee Schoenberg Index using ePrognosis.ucsf.edu. Exclusion Criteria: Hospice patient, patient with a DNR order Non-ambulatory, wheelchair/bed bound < 6 month life expectancy based on the clinical judgement by the treating physician

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cancer patients having surgery<br>This is a prospective cohort study where patients who are 65 years or older with either a history of diabetes (requiring medication or insulin) or smoking history (current smoker, smoker within the last 15 years, or ≥ 20 year pack history), facing major head and neck, thoracic, abdominal, or pelvic surgery will be screened for PAD with an ABI/TBI to establish prevalence and to compare prevalence among races to meet | Diagnostic Test: ABI/TBI<br>* ABI/TBI to be performed after surgery while patient is still admitted at the hospital.<br>Other: Questionnaires<br>* PAD symptoms questionnaire to be administered at baseline before surgery. mLEFS (included in PAD symptoms questionnaire) and WIQ to be administered at baseline before surgery. mLEFS and WIQ will be administered 1 month, 3 months, 6 months after surgery and every 6 months after that for a goal of at least 1 year.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of PAD in cancer patients at high-risk for PAD going to surgery | Completion of ABI/TBI to be able to assess prevalence of PAD | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral arterial disease (PAD), Cancer patients, 22-326