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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Randomised Trial Evaluating the Benefit of a Fitness Tracker Based Workout During Radiotherapy

NCT04517019

Bronchial Carcinoma Esophageal Carcinoma Tumor of the Brain +4 more

UNKNOWN NA

Measuring the Effect of Radiation Therapy on Patient Activity Levels

NCT02694380

Head and Neck Cancer Prostate Cancer Breast Cancer +1 more

TERMINATED

Real-time Activity Monitoring to Prevent Admissions During RadioTherapy

NCT03102229

Cancer of the Head and Neck Cancer of Lung Cancer of Esophagus +1 more

COMPLETED NA

Wearable Sensor for Biometrics During Locoregional Therapy for Head and Neck Cancer

NCT03574870

Cancer of Head and Neck

COMPLETED NA

Remote Activity Monitored by Fitbit Charge 3 in Investigating Daily Step and Sleep Data in Participants With Head and Neck Cancer Undergoing Radiation Therapy

NCT03489252

Head and Neck Carcinoma

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Digestive System Carcinoma Head and Neck Carcinoma Lung Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Observational (continuous activity monitoring, questionnaires)

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.

Monitoring Device

Intervention Type DEVICE

Wear activity monitor

Quality-of-Life Assessment

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Monitoring Device

Wear activity monitor

Intervention Type DEVICE

Quality-of-Life Assessment

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Monitor Quality of Life Assessment

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No