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Completed OBSERVATIONAL NCT02649569

Continuous Activity Monitoring During Fractionated Radiotherapy in Patients With Head and Neck, Lung, or Gastrointestinal Cancer

Continuous Activity Monitoring During Fractionated Radiotherapy: A Pilot Study

Sponsor: Montefiore Medical Center

Updated 12 times since 2017 Last updated: Apr 7, 2026 Started: Jun 1, 2015 Primary completion: Jul 1, 2017 Completion: Jul 1, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02649569, this observational or N/A phase trial focuses on Digestive System Carcinoma and Head and Neck Carcinoma and remains completed. Sponsored by Montefiore Medical Center, it has been updated 12 times since 2015, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Study Description(click to expand)

PRIMARY OBJECTIVES: I. To demonstrate the feasibility of continuous, accelerometer-based evaluation of patient activity levels before, during, and after treatment with fractionated external beam radiotherapy. SECONDARY OBJECTIVES: I. To demonstrate the feasibility of performing weekly quality of life assessments during fractionated external beam radiotherapy. II. To explore how accelerometer-based metrics change throughout patients' treatment courses and if these changes are associated with quality of life assessments, treatment interruptions, hospitalizations, and clinical outcomes. OUTLINE: Patients wear an activity monitor throughout and up 4 weeks after completion of radiation therapy. Patients who are willing may continue to wear the monitor through routine follow up appointments. Patients also complete questionnaires at evaluations, which take place prior to radiotherapy initiation, weekly during radiotherapy, and then 2 and 4 weeks after the completion of radiotherapy.

PRIMARY OBJECTIVES:

I. To demonstrate the feasibility of continuous, accelerometer-based evaluation of patient activity levels before, during, and after treatment with fractionated external beam radiotherapy.

SECONDARY OBJECTIVES:

I. To demonstrate the feasibility of performing weekly quality of life assessments during fractionated external beam radiotherapy.

II. To explore how accelerometer-based metrics change throughout patients' treatment courses and if these changes are associated with quality of life assessments, treatment interruptions, hospitalizations, and clinical outcomes.

OUTLINE:

Patients wear an activity monitor throughout and up 4 weeks after completion of radiation therapy. Patients who are willing may continue to wear the monitor through routine follow up appointments. Patients also complete questionnaires at evaluations, which take place prior to radiotherapy initiation, weekly during radiotherapy, and then 2 and 4 weeks after the completion of radiotherapy.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotActive Not Recruiting~Feb 2017 – ~Jul 2017 · 5 months · monthly snapshotActive Not Recruiting~Jul 2017 – ~Apr 2018 · 9 months · monthly snapshotActive Not Recruiting~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotActive Not Recruiting~Jun 2018 – ~Feb 2019 · 8 months · monthly snapshotCompleted~Feb 2019 – ~Jan 2021 · 23 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompletedApr 13, 2026 – present · 1 days · daily APICompleted

Change History

12 versions recorded
  1. Apr 13, 2026 — Present [daily]

    Completed

  2. Jan 2026 — Present [monthly]

    Completed

  3. Sep 2025 — Present [monthly]

    Completed

  4. Sep 2024 — Sep 2025 [monthly]

    Completed

  5. Jul 2024 — Sep 2024 [monthly]

    Completed

Show 7 earlier versions
  1. Jan 2021 — Jul 2024 [monthly]

    Completed

  2. Feb 2019 — Jan 2021 [monthly]

    Completed

  3. Jun 2018 — Feb 2019 [monthly]

    Completed

    Status: Active Not RecruitingCompleted

  4. Apr 2018 — Jun 2018 [monthly]

    Active Not Recruiting

    Phase: NANone

  5. Jul 2017 — Apr 2018 [monthly]

    Active Not Recruiting NA

  6. Feb 2017 — Jul 2017 [monthly]

    Active Not Recruiting NA

  7. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting NA

    First recorded

Jun 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

This pilot research trial studies continuous activity monitoring during fractionated radiotherapy in patients with head and neck, lung, or gastrointestinal cancer. This study explores the use of fitness trackers to study the activity levels of patients before, during, and after radiation therapy and the use of weekly assessments to measure the patients' quality of life during radiation therapy. This may allow doctors to see if there is any relationship between activity levels, quality of life, treatment interruptions, hospitalizations, and clinical outcomes.

Contact Information

Sponsor contact:
  • Montefiore Medical Center
  • National Cancer Institute (NCI)
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .