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NCT Number: NCT02649569

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

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.

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Key information

Conditions

Digestive System Carcinoma Head and Neck Carcinoma Lung Carcinoma Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Albert Einstein College of Medicine, The Bronx, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Eastern Cooperative Oncology Group (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, or gastrointestinal tract
  • Planned treatment with fractionated (>= 15 treatments) external beam radiotherapy with concurrent chemotherapy with curative intent
  • 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

Treatment and study plan

Monitoring Device

Device

Wear activity monitor

Other names: Monitor

Quality-of-Life Assessment

Other

Complete the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30

Other names: Quality of Life Assessment

Primary outcomes

  1. Number of patients who complete most (>= 80%) of the protocol-specified assessments

    Time frame: Up to 4 weeks post-chemoradiation therapy

    This pilot study will yield preliminary data on the feasibility of activity monitoring during radiotherapy as well as possible associations between activity level and various clinical and treatment-related variables. Data from the study will be summarized using standard descriptive statistics; means and standard deviations will be used for normally-distributed continuous variables, and frequencies and percentages will be used for categorical variables. Exploratory analyses for associations between activity levels and clinical and treatment-related variables will be performed using chi-square o

  2. Number of patients who successfully use the activity monitor (i.e. wearing the activity monitor throughout the treatment course)

    Time frame: Up to 4 weeks post-chemoradiation therapy

    This pilot study will yield preliminary data on the feasibility of activity monitoring during radiotherapy as well as possible associations between activity level and various clinical and treatment-related variables. Data from the study will be summarized using standard descriptive statistics; means and standard deviations will be used for normally-distributed continuous variables, and frequencies and percentages will be used for categorical variables. Exploratory analyses for associations between activity levels and clinical and treatment-related variables will be performed using chi-square o

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Continuous Activity Monitoring During Fractionated Radiotherapy: A Pilot Study

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 7, 2016
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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