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A Simple Walking Program to Enhance Concurrent Chemoradiotherapy Delivery

23 mars 2021 uppdaterad av: Albert Einstein College of Medicine

A Simple Walking Program to Enhance Concurrent Chemoradiotherapy Delivery: A Randomized Trial

By utilizing fitness trackers, this study aims to demonstrate that a simple walking program improves patients' ability to tolerate curative concurrent chemoradiotherapy without treatment interruption.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Patients will be given a commercially available fitness tracker to wear continuously throughout the course of the study. Per this study's inclusion criteria, all patients will be treated with concurrent chemoradiotherapy for a malignancy of the brain, head and neck region, lung, gastrointestinal tract, or cervix. Patients will be randomized to one of two arms: an experimental arm, where they will be instructed to meet a daily, customized step count goal, or a control arm where they will wear activity trackers but be given no specific instructions to increase their activity levels. Patients in the experimental arm who fail to meet their step count goal for three consecutive days will be contacted by a study coordinator and reminded to try to meet the activity goals. If the patient reports that his or her activity is limited by treatment-related toxicities, the patient's treating physicians will be notified to ensure that supportive care needs are being met. With such a program, this study aims to demonstrate the potential to improve patients' ability to tolerate curative concurrent chemoradiotherapy without treatment interruption.

Studietyp

Interventionell

Inskrivning (Faktisk)

166

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • New York
      • Bronx, New York, Förenta staterna, 10467
        • Montefiore Medical Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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 brain, head and neck region, lung, gastrointestinal tract, or uterine cervix
  • 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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: Activity Monitoring with Routine Care
Subjects randomized to the control arm will wear activity trackers but will have no specific instructions to increase their activity levels.
Experimentell: Pedometer-based Walking Program
Subjects randomized to the experimental arm will be instructed to meet the customized daily step count goals that are displayed on their fitness trackers. Patients who fail to meet their step count goal for three consecutive days will be contacted by a study coordinator and reminded to try to meet the activity goals. If the patient reports that his or her activity is limited by treatment-related toxicities, the patient's treating physicians will be notified to ensure that supportive care needs are being met.
Beteende: Pedometer-based Walking Program
Patients will be instructed to meet the daily step count goal displayed on their fitness tracker. If goal is not being met, study team will intervene and reinforce the importance of meeting this goal. Intervention will include a conversation with the patient, led by a study coordinator, to identify any challenges present in meeting the prescribed goal. Solutions to such challenges may be offered by the coordinator or necessary provider, such as a dietitian, when applicable.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Missed Scheduled Radiotherapy Treatments
Tidsram: During chemoradiotherapy (an average of 6 weeks)
The primary endpoint of this study is missing two or more scheduled external beam radiotherapy treatments. Treatments that are cancelled due to national holidays, inclement weather, or machine issues will not count towards this endpoint.
During chemoradiotherapy (an average of 6 weeks)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Daily Step Counts
Tidsram: During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Step counts will be recorded and measured daily from patients' fitness trackers.
During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Treatment-related Toxicities
Tidsram: During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Toxicities will be evaluated each week and scored using CTCAE version 4.03.
During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Patient-reported Quality of Life Scores
Tidsram: During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Measured weekly using the EORTC QLC-C30.
During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Number of Emergency Room Visits
Tidsram: During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Using the EMR, a record will be kept indicating the number of times each patient visits the emergency room.
During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Number of Hospitalizations
Tidsram: During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Using the EMR, a record will be kept indicating the number of times each patient is hospitalized.
During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Modified Glasgow Prognostic Scores
Tidsram: During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Scores will be calculated based on serum albumin and C-reactive protein levels.
During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Disease Progression or Recurrence
Tidsram: Through study completion, an average of 1 year
Disease progression or recurrence, to be scored by treating physicians based on available clinical and imaging data
Through study completion, an average of 1 year
Survival Status
Tidsram: Through study completion, an average of 1 year
Survival data will be kept for all patients on study throughout treatment and follow-ups.
Through study completion, an average of 1 year

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Albert Einstein College of Medicine

Utredare

  • Huvudutredare: Nitin Ohri, MD, Albert Einstein College Of Medicine

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

16 februari 2017

Primärt slutförande (Faktisk)

3 mars 2020

Avslutad studie (Faktisk)

3 mars 2021

Studieregistreringsdatum

Först inskickad

30 mars 2017

Först inskickad som uppfyllde QC-kriterierna

11 april 2017

Första postat (Faktisk)

14 april 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

25 mars 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 mars 2021

Senast verifierad

1 mars 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2017-7472

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

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Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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