Cancer of the Head and NeckRAMPARTNCT03102229
Real-time Activity Monitoring to Prevent Admissions During RadioTherapy
A study testing Enhanced Supportive Care - Status Checks and Enhanced Supportive Care - Referrals in people with Cancer of the Head and Neck and Cancer of Lung, run by Montefiore Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of the Head and Neck, Cancer of Lung, Cancer of Esophagus
- What is being tested?
- Enhanced Supportive Care - Status Checks and Enhanced Supportive Care - Referrals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
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.
Read the 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.
- Being tested
- Enhanced Supportive Care - Status Checks, Enhanced Supportive Care - Referrals
- Keywords
- Activity Monitoring, Chemotherapy, Radiotherapy
- Medical subject headings
- Head and Neck Neoplasms, Lung Neoplasms, Esophageal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Supportive Care - Status ChecksOther
Also called Daily Status Checks
Would occur everyday during treatment when a patient is deemed high-risk.
Enhanced Supportive Care - ReferralsOther
Also called Referrals
On an as-need basis, high risk patients can be referred to our nutritionist or palliative care doctor.
| Study group | Role | What they receive |
|---|---|---|
| Activity Monitoring | Experimental | 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 Receives: Other: Enhanced Supportive Care - Status Checks; Other: Enhanced Supportive Care - Referrals |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
Secondary outcomes (7)
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.
Measured: 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
Measured: 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.
Measured: During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
Treatment-related toxicities
Treatment-related toxicities, scored using CTCAE version 4.03.
Measured: During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
Disease status
Disease progression or recurrence
Measured: During chemoradiotherapy and up to two years after completion of radiotherapy.
Survival status
Measured: 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.
Measured: From time of registration to up to 4 weeks after completion of radiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study startJul 2016
- Primary completionMar 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the Head and NeckStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102229
- Sponsor's protocol ID
- 2016-6398
- Acronym
- RAMPART
- Status last verified
- Apr 2026
- First submitted
- 23 Jan 2017
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Activity Monitoring to Prevent Admissions During RadioTherapy
- ClinicalTrials.gov ID
- NCT03102229
- Acronym / sponsor ID
- RAMPART / 2016-6398
- Keywords
- Activity Monitoring, Chemotherapy, Radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 5 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Activity Monitoring | Experimental | Other: Enhanced Supportive Care - Status Checks, Other: Enhanced Supportive Care - Referrals1. 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Supportive Care - Status ChecksAlso: Daily Status ChecksWould occur everyday during treatment when a patient is deemed high-risk. | Other | Activity Monitoring |
| Enhanced Supportive Care - ReferralsAlso: ReferralsOn an as-need basis, high risk patients can be referred to our nutritionist or palliative care doctor. | Other | Activity Monitoring |
Primary outcome
Number of patients hospitalized during treatment or within 4 weeks after completing radiotherapy.
Time frame: During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
The primary endpoint of this study is hospitalization during chemoradiotherapy or within 4 weeks after completion of radiotherapy.
7 secondary outcomes
Activation of the enhanced supportive care protocol
Time frame: During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
Frequency of clinician visits and supportive care measures implemented.
Time frame: During chemoradiotherapy or within 4 weeks after completion of radiotherapy
Patient-reported quality of life scores
Time frame: During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
Treatment-related toxicities
Time frame: During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
Disease status
Time frame: During chemoradiotherapy and up to two years after completion of radiotherapy.
Survival status
Time frame: During chemoradiotherapy and and up to two years after completion of radiotherapy.
Modified Glasgow Prognostic Score
Time frame: From time of registration to up to 4 weeks after completion of radiotherapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Supportive Care - Status Checks and Enhanced Supportive Care - Referrals in people with Cancer of the Head and Neck and Cancer of Lung, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients hospitalized during treatment or within 4 weeks after completing radiotherapy. (time frame: During chemoradiotherapy or within 4 weeks after completion of radiotherapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.