Real-time Activity Monitoring to Prevent Admissions During RadioTherapy

Not Applicable

Completed

• Conditions: Cancer of the Head and Neck; Cancer of Lung; Cancer of Stomach; Cancer of Esophagus
• Interventions: Other: Enhanced Supportive Care - Status Checks; Other: Enhanced Supportive Care - Referrals

• Registration Number: NCT03102229
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-07
• Study First Submitted: 2017-01-23
• Primary Completion: 2017-03
• Study First Submitted QC: 2017-03-30
• Study First Posted: 2017-04-05
• Study Completion: 2017-09
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-24
• Last Update Posted: 2018-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Activity Monitoring	Enhanced Supportive Care - Status Checks	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
Activity Monitoring	Enhanced Supportive Care - Referrals	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

Primary Outcome Measures

Name	Time	Method
Number of patients hospitalized during treatment or within 4 weeks after completing radiotherapy.	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

Name	Time	Method
Treatment-related toxicities	During chemoradiotherapy or within 4 weeks after completion of radiotherapy.	Treatment-related toxicities, scored using CTCAE version 4.03.
Disease status	During chemoradiotherapy and up to two years after completion of radiotherapy.	Disease progression or recurrence
Frequency of clinician visits and supportive care measures implemented.	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
Survival status	During chemoradiotherapy and and up to two years after completion of radiotherapy.
Activation of the enhanced supportive care protocol	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.
Patient-reported quality of life scores	During chemoradiotherapy or within 4 weeks after completion of radiotherapy.	Patient-reported quality of life scores, measured using the EORTC QLC-C30 questionnaire.
Modified Glasgow Prognostic Score	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.

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States