Mobility and Physical Activity in Adolescent and Young Adult Cancer Patients or Survivors at Risk for Cardiovascular Morbidity and Frailty, The MOBILE AYA Study

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05169151
• Other study ID #: 2020-1048
• Secondary ID: NCI-2021-1099420
• Status: Withdrawn
• Start date: February 17, 2022
• Est. completion date: April 18, 2023

Study information

• Verified date: April 2023
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

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), grouped by disease and treatment (chemotherapy, radiotherapy), controlling for age, sex, race, and BMI.

OUTLINE:

Patients utilize smartphone application to monitor physical activity and mobility up to 180 days during treatment or post-treatment.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 18, 2023
• Est. primary completion date: April 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Nervous System Neoplasm
• Central Nervous System Neoplasms
• Frailty
• Hodgkin Lymphoma
• Lymphoma
• Malignant Solid Neoplasm
• Neoplasms
• Nervous System Neoplasms
• Non-Hodgkin Lymphoma
• Sarcoma

Intervention

Other:
• Smartphone Application
Utilize smartphone application

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To characterize patient mobility over time.	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.	Through study completion, an average of 1 year

External Links

•   M.D. Anderson Cancer Center