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Completed

NCT Number: NCT03102229

Real-time Activity Monitoring to Prevent Admissions During RadioTherapy

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enhanced Supportive Care - Status Checks

Other

Would occur everyday during treatment when a patient is deemed high-risk.

Other names: Daily Status Checks

Enhanced Supportive Care - Referrals

Other

On an as-need basis, high risk patients can be referred to our nutritionist or palliative care doctor.

Other names: Referrals

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. Treatment-related toxicities

    Time frame: During chemoradiotherapy or within 4 weeks after completion of radiotherapy.

    Treatment-related toxicities, scored using CTCAE version 4.03.

  5. Disease status

    Time frame: During chemoradiotherapy and up to two years after completion of radiotherapy.

    Disease progression or recurrence

  6. Survival status

    Time frame: During chemoradiotherapy and and up to two years after completion of radiotherapy.

  7. 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.

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Acronym: RAMPART

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 5, 2017
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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