A Randomized Trial of a Mobile Health Exercise Intervention for Older Adults With Myeloid Neoplasms (GO-EXCAP2)

University of Rochester

Status: Enrolling

Conditions: Myeloid Neoplasm; Cancer

Treatments: Behavioral: GO-EXCAP Mobile App; Behavioral: Behavioral Placebo Control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04981821

UCCS21043

R00CA237744 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This is a phase 2 randomized controlled trial (RCT) to assess the preliminary efficacy of the a mobile health exercise intervention (GO-EXCAP) versus a chemotherapy education control in 100 older patients with MN receiving outpatient chemotherapy on physical function and patient-reported outcomes (fatigue, mood, and quality of life). We will also explore the effect of the intervention on TNFα and related cytokine gene promoter methylation and their gene and protein expression.

Full description

Up to 98% of older patients with myeloid neoplasms experience physical function decline, fatigue, and mood disturbances. Mobile health exercise interventions are promising strategy to prevent physical function decline and improve fatigue and mood disturbances, but older patients with myeloid neoplasms receiving outpatient chemotherapy are understudied. The proposed study will investigate whether a novel mobile health exercise intervention that is adapted to this population can prevent physical function decline, improve fatigue and mood disturbances, and prevent worsening quality of life.

Enrollment: 170 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥60 years (conventional definition of older age in clinical trials of MN)
• Have a diagnosis of MN
• Planned for or receiving outpatient cancer-directed treatments (participants receiving consolidative or maintenance outpatient therapies after induction chemotherapy are allowed to enroll)
• English speaking
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
• No medical contraindications for exercise per oncologist
• Able to walk 4 meters as part of Short Physical Performance Battery measured walk (with or without assistive device)
• Able to provide informed consent

Exclusion criteria

• Physical, psychological, or social impairments that would interfere with subject's ability to participate in the study or participate in the intervention, as determined by the PI or the treating team

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

GO-EXCAP

Experimental group

Description:

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

Treatment:

Behavioral: GO-EXCAP Mobile App

Behavioral Placebo Control

Active Comparator group

Description:

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:

Behavioral: Behavioral Placebo Control