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A Simple Walking Program to Enhance Concurrent Chemoradiotherapy Delivery

23. mars 2021 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

166

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • New York
      • Bronx, New York, Forente stater, 10467
        • Montefiore Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: 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.
Eksperimentell: 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.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Missed Scheduled Radiotherapy Treatments
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Daily Step Counts
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Albert Einstein College of Medicine

Etterforskere

  • Hovedetterforsker: Nitin Ohri, MD, Albert Einstein College of Medicine

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

16. februar 2017

Primær fullføring (Faktiske)

3. mars 2020

Studiet fullført (Faktiske)

3. mars 2021

Datoer for studieregistrering

Først innsendt

30. mars 2017

Først innsendt som oppfylte QC-kriteriene

11. april 2017

Først lagt ut (Faktiske)

14. april 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. mars 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. mars 2021

Sist bekreftet

1. mars 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2017-7472

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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