Real-time Activity Monitoring to Prevent Admissions During RadioTherapy (RAMPART)

April 7, 2026 updated by: Montefiore Medical Center
This study will aim 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary Objective

  • 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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age > 18
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: Enhanced Supportive Care - Status Checks
Would occur everyday during treatment when a patient is deemed high-risk.
Other Names:
  • Daily Status Checks
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients hospitalized during treatment or within 4 weeks after completing radiotherapy.
Time Frame: During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
The primary endpoint of this study is hospitalization during chemoradiotherapy or within 4 weeks after completion of radiotherapy.
During chemoradiotherapy or within 4 weeks after completion of radiotherapy.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activation of the enhanced supportive care protocol
Time Frame: During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
Activation of the enhanced supportive care protocol (multidisciplinary evaluation and daily nursing/physician visits) based on recent step count data.
During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
Frequency of clinician visits and supportive care measures implemented.
Time Frame: During chemoradiotherapy or within 4 weeks after completion of radiotherapy
Clinician visits and supportive care measures that result from activation of the enhanced supportive care protocol
During chemoradiotherapy or within 4 weeks after completion of radiotherapy
Patient-reported quality of life scores
Time Frame: During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
Patient-reported quality of life scores, measured using the EORTC QLC-C30 questionnaire.
During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
Treatment-related toxicities
Time Frame: During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
Treatment-related toxicities, scored using CTCAE version 4.03.
During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
Disease status
Time Frame: During chemoradiotherapy and up to two years after completion of radiotherapy.
Disease progression or recurrence
During chemoradiotherapy and up to two years after completion of radiotherapy.
Survival status
Time Frame: During chemoradiotherapy and and up to two years after completion of radiotherapy.
During chemoradiotherapy and and up to two years after completion of radiotherapy.
Modified Glasgow Prognostic Score
Time Frame: From time of registration to up to 4 weeks after completion of radiotherapy.
Modified Glasgow Prognostic Score will be measured as a function of the C-Reactive Protein and Albumin levels that are collected throughout the study.
From time of registration to up to 4 weeks after completion of radiotherapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

January 23, 2017

First Submitted That Met QC Criteria

March 30, 2017

First Posted (Actual)

April 5, 2017

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-6398

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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