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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
40
Would occur everyday during treatment when a patient is deemed high-risk.
On an as-need basis, high risk patients can be referred to our nutritionist or palliative care doctor.
Montefiore Medical Center
The Bronx, New York, United States
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.
Time frame: During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
Activation of the enhanced supportive care protocol
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.
Frequency of clinician visits and supportive care measures implemented.
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
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
Treatment-related toxicities, scored using CTCAE version 4.03.
Time frame: During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
Disease status
Disease progression or recurrence
Time frame: During chemoradiotherapy and up to two years after completion of radiotherapy.
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Survival status
Time frame: During chemoradiotherapy and and up to two years after completion of radiotherapy.
Modified Glasgow Prognostic Score
Modified Glasgow Prognostic Score will be measured as a function of the C-Reactive Protein and Albumin levels that are collected throughout the study.
Time frame: From time of registration to up to 4 weeks after completion of radiotherapy.