Clinical trial NCT03102229: Real-time Activity Monitoring to Prevent Admissions During RadioTherapy
Official title: Real-time Activity Monitoring to Prevent Admissions During RadioTherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of the Head and Neck
Cancer of Lung
Cancer of Esophagus
Cancer of Stomach
Keywords: Activity Monitoring
Chemotherapy
Radiotherapy
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
First posted: 2017-04-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

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.

Primary outcomes:
measure: Number of patients hospitalized during treatment or within 4 weeks after completing radiotherapy.
timeFrame: During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
Secondary outcomes:
measure: Activation of the enhanced supportive care protocol
timeFrame: During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
measure: Frequency of clinician visits and supportive care measures implemented.
timeFrame: During chemoradiotherapy or within 4 weeks after completion of radiotherapy
measure: Patient-reported quality of life scores
timeFrame: During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
measure: Treatment-related toxicities
timeFrame: During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
measure: Disease status
timeFrame: During chemoradiotherapy and up to two years after completion of radiotherapy.
measure: Survival status
timeFrame: During chemoradiotherapy and and up to two years after completion of radiotherapy.
measure: Modified Glasgow Prognostic Score
timeFrame: From time of registration to up to 4 weeks after completion of radiotherapy.
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
References: