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

Albert Einstein College of Medicine

Status: Completed

Conditions: Cancer of the Head and Neck; Cancer of Lung; Cancer of Esophagus; Cancer of Stomach

Treatments: Other: Enhanced Supportive Care - Referrals; Other: Enhanced Supportive Care - Status Checks

Study type: Interventional

Funder types: Other

Identifiers

NCT03102229

2016-6398

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Activity Monitoring

Experimental group

Description:

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

Treatment:

Other: Enhanced Supportive Care - Status Checks

Other: Enhanced Supportive Care - Referrals