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Clinical Trials/NCT05169151
NCT05169151WithdrawnNot Applicable

A Study to Digitally Phenotype Mobility and Physical Activity in Adolescent and Young Adult (AYA) Patients at Risk for Cardiovascular Morbidity and Frailty: MOBILE AYA

M.D. Anderson Cancer Center1 site in 1 countryStarted: February 17, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
1
Primary Endpoint
To characterize patient mobility over time.

Study Overview

Brief Summary

This study attempts to learn more about the activity levels of adolescent and young adult (AYA) cancer patients or survivors at risk for cardiovascular morbidity and frailty by using a smartphone application called Beiwe. Collecting activity level data on AYA cancer patients or survivors may help patients achieve better quality of life.

Detailed Description

PRIMARY OBJECTIVES:

I. To characterize patient mobility over time based upon smartphone sensor data, including dwell time at home and hospital, as well as time spent away from home or hospital, considering patients actively undergoing treatment (time referenced to treatment start) separately from those following treatment (time referenced to treatment end).

II. To characterize patient physical activity over time based upon smartphone sensor data, during and following treatment (separately), including inactivity time and activity level, at home and hospital and away from home or hospital, considering patients actively undergoing treatment (time referenced to treatment start) separately from those following treatment (time referenced to treatment end).

SECONDARY OBJECTIVES:

I. To characterize patient mobility over time based upon smartphone sensor data, including dwell time at home and hospital, as well as time spent away from home or hospital, considering patients actively undergoing treatment (time referenced to treatment start) separately from those following treatment (time referenced to treatment end), grouped by disease and treatment (chemotherapy, radiotherapy), controlling for age, sex, race, and body mass index (BMI).

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
15 Years to 39 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients age 15-39 at the time of study entry
  • Patients must be within 3 weeks of starting anti-cancer therapy
  • Patients must have a diagnosis of Hodgkin lymphoma, non-Hodgkin lymphoma, sarcoma and have plans to receive anthracyclines or radiation therapy to the chest OR
  • have a diagnosis of a central nervous system (CNS) tumor OR
  • have plans to receive a stem cell transplant
  • Patients must have smartphone device and regular access to internet
  • Patients must be English-speaking

Exclusion Criteria

  • Patients that are a ward of the state

Outcomes

Primary Outcomes

To characterize patient mobility over time.

Time Frame: Through study completion, an average of 1 year

Will be analyzed by linear mixed-effect models with relation to time point (30, 60, 90, 120, 150, and 180 days), blocking on patient, with differences among time points assessed by Tukey-adjusted contrasts.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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