Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2025-12-24 @ 4:20 PM
NCT ID:
NCT03971266
Brief Summary:
This trial studies the use of movement and fitness trackers in determining performance status of patients with cancer who are taking part in early phase clinical. Movement and fitness trackers record movement and a number of different metrics such as steps, heart rate, and calories burned. The use of movement and fitness trackers can provide a more objective and precise estimate of patient performance status and help identify those most at risk for adverse events and hospitalization.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine if in-office movement trackers identify those patients who are at highest risk for serious adverse events (SAEs) on early and developmental therapeutics (EDT) cancer trials.
SECONDARY OBJECTIVES:
Secondary objectives are related to outpatient activity trackers. I. To determine the association between the occurrence of SAEs and early trial termination, with baseline measurement of activity classification using outpatient activity trackers in the 7 days after screening visit.
II. To determine the association between the occurrence of SAEs and early trial termination, with the change in activity level classification between the week after screening visit and the week after the start of EDT.
III. To determine the association between the occurrence of SAEs and early trial termination, with averaged activity level classification in the first 4 weeks of the EDT.
OUTLINE:
Patients participant in movement assessment during 2 clinical trial visits. Patients also wear a Fitbit to track movements and complete a smartphone based Patient Reported Outcomes (PRO) diary over 5-10 minutes to measure physical function, fatigue, sleep disturbance, social isolation, appetite, and body weight for up to 180 days.
Study:
NCT03971266
Study Brief:
Protocol Section:
NCT03971266