What this study is
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.
What's being tested
- GO-EXCAP Mobile App
Intervention · BEHAVIORAL
A mobile app delivery platform to deliver an exercise program [Exercise for Cancer Patients (EXCAP©®)]. EXCAP©®) is a progressive walking and resistance exercise program
- Behavioral Placebo Control
Intervention · BEHAVIORAL
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.
Study details
- Official title
- A Pilot Randomized Trial of a Mobile Health Exercise Intervention for Older Patients With Myeloid Neoplasms
- Sponsor
- University of Rochester
- Conditions
- Cancer · Myeloid Neoplasm
- Enrolling
- 170 people
- Starts
- 2022-01-03
- Est. completion
- 2027-12-31
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 60 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Rochester Medical Center/Wilmot Cancer Institute
Rochester, New York, United States
- Kah Poh Loh, MBBCh BAO, MS · Contact
Recruiting
Study team
Sponsor
University of Rochester
Study ID UCCS21043
Principal investigator
Kah Poh Loh
University of Rochester
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.