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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 41 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Digestive System Carcinoma
• Head and Neck Carcinoma
• Lung Carcinoma

Interventions

Type	Name	Description
DEVICE	Monitoring Device	Wear activity monitor
OTHER	Quality-of-Life Assessment	Complete the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2016-01-07
• Last updated: 2026-04-13

Locations

2 sites across 1 country: United States