Montefiore Medical Center
The Bronx, New York, 10467, United States
NCT Number: NCT03102229
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
The Bronx, New York, 10467, United States
Primary Objective
Secondary Objectives
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Would occur everyday during treatment when a patient is deemed high-risk.
Other names: Daily Status Checks
On an as-need basis, high risk patients can be referred to our nutritionist or palliative care doctor.
Other names: Referrals
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
Patient-reported quality of life scores, measured using the EORTC QLC-C30 questionnaire.
Time frame: During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
Treatment-related toxicities, scored using CTCAE version 4.03.
Time frame: During chemoradiotherapy and up to two years after completion of radiotherapy.
Disease progression or recurrence
Time frame: During chemoradiotherapy and and up to two years after completion of radiotherapy.
Time frame: 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.
Montefiore Medical Center
Other
Acronym: RAMPART
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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