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

Primary Purpose

Cancer of the Head and Neck, Cancer of Lung, Cancer of Esophagus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced Supportive Care - Status Checks
Enhanced Supportive Care - Referrals
Sponsored by
Albert Einstein College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer of the Head and Neck focused on measuring Activity Monitoring, Chemotherapy, Radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Activity Monitoring

Arm Description

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 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

Outcomes

Primary Outcome Measures

Number of patients hospitalized during treatment or within 4 weeks after completing radiotherapy.
The primary endpoint of this study is hospitalization during chemoradiotherapy or within 4 weeks after completion of radiotherapy.

Secondary Outcome Measures

Activation of the enhanced supportive care protocol
Activation of the enhanced supportive care protocol (multidisciplinary evaluation and daily nursing/physician visits) based on recent step count data.
Frequency of clinician visits and supportive care measures implemented.
Clinician visits and supportive care measures that result from activation of the enhanced supportive care protocol
Patient-reported quality of life scores
Patient-reported quality of life scores, measured using the EORTC QLC-C30 questionnaire.
Treatment-related toxicities
Treatment-related toxicities, scored using CTCAE version 4.03.
Disease status
Disease progression or recurrence
Survival status
Modified Glasgow Prognostic Score
Modified Glasgow Prognostic Score will be measured as a function of the C-Reactive Protein and Albumin levels that are collected throughout the study.

Full Information

First Posted
January 23, 2017
Last Updated
May 24, 2018
Sponsor
Albert Einstein College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03102229
Brief Title
Real-time Activity Monitoring to Prevent Admissions During RadioTherapy
Acronym
RAMPART
Official Title
Real-time Activity Monitoring to Prevent Admissions During RadioTherapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of the Head and Neck, Cancer of Lung, Cancer of Esophagus, Cancer of Stomach
Keywords
Activity Monitoring, Chemotherapy, Radiotherapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Activity Monitoring
Arm Type
Experimental
Arm Description
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 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
Intervention Type
Other
Intervention Name(s)
Enhanced Supportive Care - Status Checks
Other Intervention Name(s)
Daily Status Checks
Intervention Description
Would occur everyday during treatment when a patient is deemed high-risk.
Intervention Type
Other
Intervention Name(s)
Enhanced Supportive Care - Referrals
Other Intervention Name(s)
Referrals
Intervention Description
On an as-need basis, high risk patients can be referred to our nutritionist or palliative care doctor.
Primary Outcome Measure Information:
Title
Number of patients hospitalized during treatment or within 4 weeks after completing radiotherapy.
Description
The primary endpoint of this study is hospitalization during chemoradiotherapy or within 4 weeks after completion of radiotherapy.
Time Frame
During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
Secondary Outcome Measure Information:
Title
Activation of the enhanced supportive care protocol
Description
Activation of the enhanced supportive care protocol (multidisciplinary evaluation and daily nursing/physician visits) based on recent step count data.
Time Frame
During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
Title
Frequency of clinician visits and supportive care measures implemented.
Description
Clinician visits and supportive care measures that result from activation of the enhanced supportive care protocol
Time Frame
During chemoradiotherapy or within 4 weeks after completion of radiotherapy
Title
Patient-reported quality of life scores
Description
Patient-reported quality of life scores, measured using the EORTC QLC-C30 questionnaire.
Time Frame
During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
Title
Treatment-related toxicities
Description
Treatment-related toxicities, scored using CTCAE version 4.03.
Time Frame
During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
Title
Disease status
Description
Disease progression or recurrence
Time Frame
During chemoradiotherapy and up to two years after completion of radiotherapy.
Title
Survival status
Time Frame
During chemoradiotherapy and and up to two years after completion of radiotherapy.
Title
Modified Glasgow Prognostic Score
Description
Modified Glasgow Prognostic Score will be measured as a function of the C-Reactive Protein and Albumin levels that are collected throughout the study.
Time Frame
From time of registration to up to 4 weeks after completion of radiotherapy.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Real-time Activity Monitoring to Prevent Admissions During RadioTherapy

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