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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03102229
Recruitment Status : Completed
First Posted : April 5, 2017
Last Update Posted : May 29, 2018
Sponsor:
Information provided by (Responsible Party):
Nitin Ohri, Albert Einstein College of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer of the Head and Neck Cancer of Lung Cancer of Esophagus Cancer of Stomach Other: Enhanced Supportive Care - Status Checks Other: Enhanced Supportive Care - Referrals Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Real-time Activity Monitoring to Prevent Admissions During RadioTherapy
Study Start Date : July 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Referrals




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102229


Locations
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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Albert Einstein College of Medicine
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Responsible Party: Nitin Ohri, Associate Professor, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT03102229    
Other Study ID Numbers: 2016-6398
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: May 29, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nitin Ohri, Albert Einstein College of Medicine:
Activity Monitoring
Chemotherapy
Radiotherapy
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Stomach Neoplasms
Esophageal Neoplasms
Lung Neoplasms
Neoplasms by Site
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Esophageal Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases