Real-time Activity Monitoring to Prevent Admissions During RadioTherapy

Cancer of Stomach Clinical Trial

— RAMPART  

Official title:

Real-time Activity Monitoring to Prevent Admissions During RadioTherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03102229
• Other study ID #: 2016-6398
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: September 2017

Study information

• Verified date: May 2018
• Source: Albert Einstein College of Medicine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer of Esophagus
• Cancer of Lung
• Cancer of Stomach
• Cancer of the Head and Neck
• Esophageal Neoplasms
• Head and Neck Neoplasms
• Lung Neoplasms
• Stomach Neoplasms

Intervention

Other:
• Enhanced Supportive Care - Status Checks
Would occur everyday during treatment when a patient is deemed high-risk.
• Enhanced Supportive Care - Referrals
On an as-need basis, high risk patients can be referred to our nutritionist or palliative care doctor.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
Secondary	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.	During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
Secondary	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	During chemoradiotherapy or within 4 weeks after completion of radiotherapy
Secondary	Patient-reported quality of life scores	Patient-reported quality of life scores, measured using the EORTC QLC-C30 questionnaire.	During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
Secondary	Treatment-related toxicities	Treatment-related toxicities, scored using CTCAE version 4.03.	During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
Secondary	Disease status	Disease progression or recurrence	During chemoradiotherapy and up to two years after completion of radiotherapy.
Secondary	Survival status		During chemoradiotherapy and and up to two years after completion of radiotherapy.
Secondary	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.	From time of registration to up to 4 weeks after completion of radiotherapy.