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Mobile Health Exercise for Cancer (GO-EXCAP2 Trial)

N/A

Recruiting

Led By Kah Poh Loh

Research Sponsored by University of Rochester

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0-3

Age ≥60 years (conventional definition of older age in clinical trials of MN)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Summary

This trial is testing a new mobile health intervention to see if it's more effective than chemotherapy education in improving physical function and patient-reported outcomes in 100 older patients with MN.

Who is the study for?

This trial is for English-speaking older adults (60+) with Myeloid Neoplasms who are undergoing outpatient chemotherapy. They should be able to walk and have an ECOG status of 0-3, indicating varying levels of functional capacity. Those with conditions that prevent exercise or impair participation in the study cannot join.

What is being tested?

The trial is testing a mobile health exercise app called GO-EXCAP against a control group receiving chemotherapy education. The goal is to see if the app improves physical function, mood, fatigue, and quality of life in patients compared to just getting educational support.

What are the potential side effects?

Since this intervention involves exercise facilitated by an app rather than medication, side effects may include typical risks associated with physical activity such as muscle soreness or strain especially given the older population involved.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can care for myself but may not be able to do heavy physical work.

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I am 60 years old or older.

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I have been diagnosed with membranous nephropathy (MN).

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I can walk 4 meters, with or without help from a device.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Difference between experimental and active comparator arms- Physical Function

Secondary study objectives

Difference between experimental and active comparator arms -Depression

Difference between experimental and active comparator arms -Fatigue

Difference between experimental and active comparator arms -Quality of Life

Other study objectives

Difference between experimental and active comparator arms -Inflammatory cytokines

Difference between experimental and active comparator arms- DNA methylation in the TNFα promoter region

Difference between experimental and active comparator arms- TNFα gene expression

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: GO-EXCAPExperimental Treatment1 Intervention

GO-EXCAP Mobile App involves the use of a mobile app delivery platform to deliver an exercise program \[Exercise for Cancer Patients (EXCAP©®)\]. EXCAP©®) is a progressive walking and resistance exercise program

Group II: Behavioral Placebo ControlActive Control1 Intervention

Participants will meet with an oncology nurse (for approximately 60 min) to review the NCI booklet Chemotherapy and You: Support for People With Cancer, which includes facts about chemotherapy and its side effects. They will be provided with NCI online resources to review at home.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GO-EXCAP Mobile App

2020

N/A

~30

0 / 4Eligibility criteria met