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.
Brief Title
Real-time Activity Monitoring to Prevent Admissions During RadioTherapy
Detailed 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.
* 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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Cancer of the Head and Neck
Cancer of Lung
Cancer of Esophagus
Cancer of Stomach
Eligibility 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.
* 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.
Inclusion 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.
* 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.
Gender
All
Gender Based
false
Keywords
Activity Monitoring
Chemotherapy
Radiotherapy
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03102229
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2016-6398
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Real-time Activity Monitoring to Prevent Admissions During RadioTherapy
Primary Outcomes
Outcome Description
The primary endpoint of this study is hospitalization during chemoradiotherapy or within 4 weeks after completion of radiotherapy.
Outcome Measure
Number of patients hospitalized during treatment or within 4 weeks after completing radiotherapy.
Outcome Time Frame
During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
Secondary Outcomes
Outcome Description
Activation of the enhanced supportive care protocol (multidisciplinary evaluation and daily nursing/physician visits) based on recent step count data.
Outcome Time Frame
During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
Outcome Measure
Activation of the enhanced supportive care protocol
Outcome Description
Clinician visits and supportive care measures that result from activation of the enhanced supportive care protocol
Outcome Time Frame
During chemoradiotherapy or within 4 weeks after completion of radiotherapy
Outcome Measure
Frequency of clinician visits and supportive care measures implemented.
Outcome Description
Patient-reported quality of life scores, measured using the EORTC QLC-C30 questionnaire.
Outcome Time Frame
During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
Outcome Measure
Patient-reported quality of life scores
Outcome Description
Treatment-related toxicities, scored using CTCAE version 4.03.
Outcome Time Frame
During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
Outcome Measure
Treatment-related toxicities
Outcome Description
Disease progression or recurrence
Outcome Time Frame
During chemoradiotherapy and up to two years after completion of radiotherapy.
Outcome Measure
Disease status
Outcome Time Frame
During chemoradiotherapy and and up to two years after completion of radiotherapy.
Outcome Measure
Survival status
Outcome Description
Modified Glasgow Prognostic Score will be measured as a function of the C-Reactive Protein and Albumin levels that are collected throughout the study.
Outcome Time Frame
From time of registration to up to 4 weeks after completion of radiotherapy.
Outcome Measure
Modified Glasgow Prognostic Score
Start Date
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Nitin Ohri
Investigator Email
nitin.ohri@einsteinmed.org
Investigator Phone