Clinical trial NCT04035499: A Mobile Health Exercise Intervention for Older Patients With Myeloid Neoplasms
Official title: A Mobile Health Exercise Intervention for Older Patients With Myeloid Neoplasms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intervention
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-07-29
Enrollment: 25
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Evaluating the feasibility of a mobile health exercise intervention in older adults with myeloid neoplasms
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a pilot study to evaluate the feasibility of a mobile health exercise intervention (GO-EXCAP Mobile App) over 7 weeks in 25 patients with myeloid neoplasms receiving hypomethylating agents.

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 hypomethylating agents are understudied. The proposed study will evaluate a novel mobile health exercise intervention that is adapted to older patients with myeloid neoplasms receiving outpatient hypomethylating agents and investigate whether and how exercise can prevent physical function decline, improve fatigue and mood disturbances, and prevent worsening quality of life.

Eligibility criteria: Inclusion Criteria:

* Age is greater than or equal to 60 years
* Have a diagnosis of MN
* Receiving outpatient chemotherapy (e.g., HMA)
* English speaking
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* 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

Platelet count of 10,000 per microliter or less in the most recent blood draw (due to risk of spontaneous bleeding) prior to transfusion (i.e., patients are allowed to enroll if their platelet count is 10,000 per microliter or less but is scheduled to receive transfusion the day of consent)

Primary outcomes:
measure: Feasibility: Percentage of Patients Entering Any Exercise Data Into the Mobile App ≥50% of the Study Period Days, Excluding Hospitalization
timeFrame: 8-12 weeks
measure: Feasibility: Percentage of Patients Entering Resistance Data Into the Mobile App ≥50% of the Study Period Days, Excluding Hospitalization
timeFrame: 8-12 weeks
measure: Feasibility: Recruitment Rates
timeFrame: Week 0, prior to baseline
measure: Feasibility: Retention Rates
timeFrame: 8-12 weeks
Secondary outcomes:
measure: Pre-post Changes in Short Physical Performance Battery (SPPB)
timeFrame: Baseline, Post-Intervention, Changes from baseline to post-intervention (an average of 8-12 weeks)
measure: Pre-post Changes in Brief Fatigue Inventory (BFI)
timeFrame: Baseline, Post-Intervention, Changes from baseline to post-intervention (an average of 8-12 weeks)
measure: Pre-post Changes in the Center for Epidemiological Studies Depression Scale (CES-D)
timeFrame: 8-12 weeks
measure: Pre-post Changes in Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu)
timeFrame: Baseline, Post-Intervention, Changes from baseline to post-intervention (an average of 8-12 weeks)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Kah Poh Loh
role: PRINCIPAL_INVESTIGATOR
References:
citation: Loh KP, Kleckner IR, Lin PJ, Mohile SG, Canin BE, Flannery MA, Fung C, Dunne RF, Bautista J, Culakova E, Kleckner AS, Peppone LJ, Janelsins M, McHugh C, Conlin A, Cho JK, Kasbari S, Esparaz BT, Kuebler JP, Mustian KM. Effects of a Home-based Exercise Program on Anxiety and Mood Disturbances in Older Adults with Cancer Receiving Chemotherapy. J Am Geriatr Soc. 2019 May;67(5):1005-1011. doi: 10.1111/jgs.15951.
citation: Loh KP, Ramsdale E, Culakova E, Mendler JH, Liesveld JL, O'Dwyer KM, McHugh C, Gilles M, Lloyd T, Goodman M, Klepin HD, Mustian KM, Schnall R, Mohile SG. Novel mHealth App to Deliver Geriatric Assessment-Driven Interventions for Older Adults With Cancer: Pilot Feasibility and Usability Study. JMIR Cancer. 2018 Oct 29;4(2):e10296. doi: 10.2196/10296.
citation: Loh KP, Sanapala C, Watson EE, Jensen-Battaglia M, Janelsins MC, Klepin HD, Schnall R, Culakova E, Vertino P, Susiarjo M, Lin PJ, Mendler JH, Liesveld JL, Huselton EJ, Taberner K, Mohile SG, Mustian K. A single-arm pilot study of a mobile health exercise intervention (GO-EXCAP) in older patients with myeloid neoplasms. Blood Adv. 2022 Jul 12;6(13):3850-3860. doi: 10.1182/bloodadvances.2022007056.