Real-time Activity Monitoring to Prevent Admissions During RadioTherapy

NCT03102229 | Completed DMC

• 1 other identifier: 2016-6398
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Activity Monitoring; Chemotherapy; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Activation of the enhanced supportive care protocol

  During chemoradiotherapy or within 4 weeks after completion of radiotherapy.

• Frequency of clinician visits and supportive care measures implemented.

  During chemoradiotherapy or within 4 weeks after completion of radiotherapy

• Patient-reported quality of life scores

  During chemoradiotherapy or within 4 weeks after completion of radiotherapy.

• Treatment-related toxicities

  During chemoradiotherapy or within 4 weeks after completion of radiotherapy.

• Disease status

  During chemoradiotherapy and up to two years after completion of radiotherapy.

Study Arms (1)

Activity Monitoring

EXPERIMENTAL

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

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

Interventions

Enhanced Supportive Care - Status Checks OTHER

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

Also known as: Daily Status Checks

Activity Monitoring

Enhanced Supportive Care - Referrals OTHER

On an as-need basis, high risk patients can be referred to our nutritionist or palliative care doctor.

Also known as: Referrals

Activity Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Lung Neoplasms; Esophageal Neoplasms; Stomach Neoplasms

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: April 5, 2017
• Study Start: July 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: September 1, 2017
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)