CompletedNot Applicable

Real-time Activity Monitoring to Prevent Admissions During RadioTherapy

United States40 participantsStarted 2016-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: During chemoradiotherapy or within 4 weeks after completion of radiotherapy.

Trial details

NCT IDNCT03102229

SponsorMontefiore Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-03