Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
NCT Number: NCT03489252
This pilot trial studies remote activity monitored by Fitbit Charge 3 in investigating daily step and sleep data in participants with head and neck cancer who are undergoing radiation therapy. A wearable remote activity tracking device, such as the Fitbit Charge 3, may help to detect early signs of treatment or disease-related symptoms, improve quality of life, decrease emergency room visits, and decrease hospitalizations in participants with head and neck cancer.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19107, United States
PRIMARY OBJECTIVES:
I. Determine compliance with remote activity monitoring (RAM) in patients receiving radiotherapy (RT) or chemoradiotherapy (CRT) for head and neck cancer (HNC).
SECONDARY OBJECTIVES:
I. Evaluate feasibility of recruitment to the Remote Activity Monitoring Pilot (RAMP).
II. Investigate patient acceptability of RAM. III. Evaluate compliance with electronic patient-reported outcomes (ePROs) in this patient population.
IV. Estimate the change in average daily steps associated with a one-unit change in health score as collected on ePRO analysis (analyze associations between RAM data and ePROs).
V. Investigate correlations among step data, quality of life (QOL), and emergency room (ER) visits/hospitalizations.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Wear Fitbit Charge 3
Time frame: Through study completion, an average of 3 months
Daily compliance with remote activity monitoring (RAM) will be defined as wearing the device for 19/24 hours daily (80% daily use). Overall study period compliance will be defined as usage of the device for at least 70% of the days under observation where it should have been worn. The overall study period compliance rate along with a one-sided exact 95% confidence interval will be estimated.
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Other
RAMP (Remote Activity Monitoring Pilot): A Feasibility Study Investigating Daily Step and Sleep Data in Combination With Electronic Patient-Reported Outcomes in Adult Patients With Head and Neck Cancer
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.
Published trials that share one or more normalized conditions with this study.
NCT06749301
Head and Neck Carcinoma
Rome, Italy
View Trial DetailsNCT02649569
Digestive System Carcinoma, Head and Neck Carcinoma
The Bronx, New York, United States
View Trial DetailsNCT03370276
Carcinoma, Carcinoma, Squamous Cell
Tampa, Florida, United States
View Trial DetailsNCT05115825
Head and Neck Carcinoma
Portland, Oregon, United States
View Trial Details