NCT05169151

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 23, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

February 17, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2023

Completed
Last Updated

April 24, 2023

Status Verified

April 1, 2023

Enrollment Period

1.2 years

First QC Date

December 9, 2021

Last Update Submit

April 20, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Observational (physical activity tracking)

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

Other: Smartphone Application

Interventions

Utilize smartphone application

Also known as: App, Smartphone App
Observational (physical activity tracking)

Eligibility Criteria

Age15 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adolescent and young adults with cancer who are at risk for developing cardiovascular disease and/or frailty and are within 3 weeks of starting anti-cancer therapy.

You may qualify if:

  • 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

You may not qualify if:

  • Patients that are a ward of the state

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Central Nervous System NeoplasmsHodgkin DiseaseLymphoma, Non-HodgkinSarcoma

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesLymphomaNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

Multiprotein ComplexesMacromolecular SubstancesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Michael Roth, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2021

First Posted

December 23, 2021

Study Start

February 17, 2022

Primary Completion

April 18, 2023

Study Completion

April 18, 2023

Last Updated

April 24, 2023

Record last verified: 2023-04

Locations