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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

114 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-22

Study Completion Date

2026-02-28

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

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Detailed Description

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Conditions

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Peripheral Arterial Disease (PAD) in Cancer Patients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cancer patients having surgery

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

ABI/TBI

Intervention Type DIAGNOSTIC_TEST

ABI/TBI to be performed after surgery while patient is still admitted at the hospital.

Questionnaires

Intervention Type OTHER

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.

Interventions

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ABI/TBI

ABI/TBI to be performed after surgery while patient is still admitted at the hospital.

Intervention Type DIAGNOSTIC_TEST

Questionnaires

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.

Intervention Type OTHER

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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No