Real-time Activity Monitoring to Prevent Admissions During RadioTherapy
NCT ID: NCT03102229
Last Updated: 2018-05-29
Study Results
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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COMPLETED
NA
40 participants
INTERVENTIONAL
2016-07-31
2017-09-30
Brief Summary
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Detailed Description
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* To demonstrate that implementation of a rapid, multidisciplinary supportive care program for patients receiving chemoradiotherapy who are deemed to be at high risk for hospitalization based on real-time pedometer data will reduce the rate of hospitalization during chemoradiotherapy or within four weeks of radiotherapy completion.
Secondary Objectives
* To demonstrate the feasibility of a program of rapid, multidisciplinary supportive care triggered by real-time pedometer data.
* To characterize the interventions enacted by our multidisciplinary supportive care team.
* To explore if interventions enacted by our multidisciplinary team for patients with low recent step counts lead to increased step counts in subsequent weeks compared to historical controls.
* To collect biospecimens for future correlative studies examining associations between blood/urine biomarkers and patient activity levels.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Activity Monitoring
1. Enhanced Supportive Care - Status Checks Would occur everyday during treatment when a patient is deemed high-risk based on activity level. Other Names: •Daily Status Checks
2. Enhanced Supportive Care - Referrals On an as-need basis, high risk patients can be referred to our nutritionist or palliative care doctor. Other Names: •Referrals
Enhanced Supportive Care - Status Checks
Would occur everyday during treatment when a patient is deemed high-risk.
Enhanced Supportive Care - Referrals
On an as-need basis, high risk patients can be referred to our nutritionist or palliative care doctor.
Interventions
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Enhanced Supportive Care - Status Checks
Would occur everyday during treatment when a patient is deemed high-risk.
Enhanced Supportive Care - Referrals
On an as-need basis, high risk patients can be referred to our nutritionist or palliative care doctor.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ECOG performance status 0-2
* Able to ambulate independently (without the assistance of a cane or walker)
* Diagnosis of invasive malignancy of the head and neck region, lung, esophagus, or stomach
* Planned treatment with fractionated (≥15 treatments) external beam radiotherapy with concurrent chemotherapy (or cetuximab) with curative intent (including preoperative or postoperative treatment)
* Women of childbearing potential must:
* Have a negative serum or urine pregnancy test within 72 hours prior to the start of study therapy
* Agree to utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study therapy is completed
* Be advised of the importance of avoiding pregnancy during trial participation and the potential risks of an unintentional pregnancy
* All patients must sign study specific informed consent prior to study entry.
18 Years
ALL
No
Sponsors
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Albert Einstein College of Medicine
OTHER
Responsible Party
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Nitin Ohri
Associate Professor
Locations
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Montefiore Medical Center
The Bronx, New York, United States
Countries
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Other Identifiers
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2016-6398
Identifier Type: -
Identifier Source: org_study_id
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