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

Withdrawn

• Conditions: Hodgkin Lymphoma; Malignant Solid Neoplasm; Non-Hodgkin Lymphoma; Sarcoma; Central Nervous System Neoplasm
• Interventions: Other: Smartphone Application

• Registration Number: NCT05169151
• Lead Sponsor: M.D. Anderson Cancer Center

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).

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-12-09
• Study First Submitted QC: 2021-12-22
• Study First Posted: 2021-12-23
• Study Start: 2022-02-17
• Status Verified: 2023-04
• Primary Completion: 2023-04-18
• Study Completion: 2023-04-18
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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Exclusion Criteria

• Patients that are a ward of the state

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (physical activity tracking)	Smartphone Application	Patients utilize smartphone application to monitor physical activity and mobility up to 180 days during treatment or post-treatment.

Primary Outcome Measures

Name	Time	Method
To characterize patient mobility over time.	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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States