RAMPART: Real-time Activity Monitoring to Prevent Admissions During RadioTherapy

Sponsor

Albert Einstein College of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT03102229

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

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.

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	N/A

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 Design

Study Type:

Interventional

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 :

Jul 1, 2016

Actual Primary Completion Date :

Mar 1, 2017

Actual Study Completion Date :

Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Activity Monitoring 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	Other: Enhanced Supportive Care - Status Checks Would occur everyday during treatment when a patient is deemed high-risk. Other Names: 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 Names: Referrals

Arm

Intervention/Treatment

Experimental: Activity Monitoring

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

Other: Enhanced Supportive Care - Status Checks

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

Other Names:

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 Names:

Referrals

Outcome Measures

Primary Outcome Measures

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

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.
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
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.
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
Survival status [During chemoradiotherapy and and up to two years after completion of radiotherapy.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.