Cancer, Myeloid Neoplasm
Conditions
Keywords
mobile health exercise intervention, Myeloid Neoplasm, GO-EXCAP
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.
Interventions
BEHAVIORALGO-EXCAP Mobile App
A mobile app delivery platform to deliver an exercise program \[Exercise for Cancer Patients (EXCAP©®)\]. EXCAP©®) is a progressive walking and resistance exercise program
BEHAVIORALBehavioral Placebo Control
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.
Sponsors
University of Rochester
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference between experimental and active comparator arms- Physical Function | 12 Weeks | Changes in physical function measured using the Short Physical Performance Battery (SPPB) which an objective physical assessment evaluating lower extremity physical function (score ranges from 0-12; higher score indicates better physical function). It is comprised of 3 components: a four-meter walk, repeated chair stands and a balance test (the score for each component ranges from 0-4). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference between experimental and active comparator arms -Fatigue | 12 Weeks | Changes in fatigue measures using the Brief Fatigue Inventory (BFI) which is a 9-item, patient-reported instrument. The score for each item ranges from 0-10, a higher score indicates higher self-reported levels of fatigue. |
| Difference between experimental and active comparator arms -Depression | 12 Weeks | Changes in depression measured using the Center for Epidemiological Studies Depression Scale (CES-D) which is a 20-item depression scale. The score for each item ranges from 0-3, a higher score indicates higher self-reported depression levels. |
| Difference between experimental and active comparator arms -Quality of Life | 12 Weeks | Changes in quality of life measured using the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) scale. It consists of 44 items divided into 5 subscales: physical well-being (PWB), social well-being (SWB), emotional well-being (EWB), functional well-being (FWB) and leukemia-specific concerns. The score for each item ranges from 0-4. After reversing the scoring of negatively worded items, all the scores are summated. A higher score indicates better quality of life. |
Countries
United States
Contacts
CONTACTKah Poh Loh
CONTACTBecky Gravenstede
PRINCIPAL_INVESTIGATORKah Poh Loh
University of Rochester
Outcome results
None listed