Real-time Activity Monitoring to Prevent Admissions During RadioTherapy
Purpose
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.
Conditions
- Cancer of the Head and Neck
- Cancer of Lung
- Cancer of Esophagus
- Cancer of Stomach
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Activity Monitoring |
Enhanced Supportive Care - Status Checks Would occur everyday during treatment when a patient is deemed high-risk based on activity level. Other Names: •Daily Status Checks Enhanced Supportive Care - Referrals On an as-need basis, high risk patients can be referred to our nutritionist or palliative care doctor. Other Names: •Referrals |
|
More Details
- Status
- Completed
- Sponsor
- Albert Einstein College of Medicine
Study Contact
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.