Clinical trial NCT04981821: A Randomized Trial of a Mobile Health Exercise Intervention for Older Adults With Myeloid Neoplasms
Official title: A Pilot Randomized Trial of a Mobile Health Exercise Intervention for Older Patients With Myeloid Neoplasms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Myeloid Neoplasm
Keywords: mobile health exercise intervention
Myeloid Neoplasm
GO-EXCAP
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-07-29
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference between experimental and active comparator arms- Physical Function
timeFrame: 12 Weeks
Secondary outcomes:
measure: Difference between experimental and active comparator arms -Fatigue
timeFrame: 12 Weeks
measure: Difference between experimental and active comparator arms -Depression
timeFrame: 12 Weeks
measure: Difference between experimental and active comparator arms -Quality of Life
timeFrame: 12 Weeks
Other outcomes:
measure: Difference between experimental and active comparator arms -Inflammatory cytokines
timeFrame: 12 Weeks
measure: Difference between experimental and active comparator arms- DNA methylation in the TNFα promoter region
timeFrame: 12 Weeks
measure: Difference between experimental and active comparator arms- TNFα gene expression
timeFrame: 12 Weeks
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center/Wilmot Cancer Institute
state: New York
Study officials:
affiliation: University of Rochester
name: Kah Poh Loh
role: PRINCIPAL_INVESTIGATOR
References: