Clinical trial · Interventional
Real-time Activity Monitoring to Prevent Admissions During RadioTherapy
NCT03102229CI-TRIAL-00108004RAMPARTcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Esophagus | Malignant Esophageal Neoplasm | ALIAS | 0.90 |
| Cancer of Lung | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Cancer of Stomach | Malignant Gastric Neoplasm | ALIAS | 0.90 |
| Cancer of the Head and Neck | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enhanced Supportive Care - Referrals | Other | — | UNRESOLVED |
| Enhanced Supportive Care - Status Checks | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Activity Monitoring
- description
- 1. 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 2. 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
- interventionNames
- Other: Enhanced Supportive Care - Status Checks
- Other: Enhanced Supportive Care - Referrals
Primary outcomes (1)
- 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.
- description
- The primary endpoint of this study is hospitalization during chemoradiotherapy or within 4 weeks after completion of radiotherapy.
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.