A Mobile Health Exercise Intervention for Older Patients With Myeloid Neoplasms (GO- EXCAP) Mobile App

Intervention Clinical Trial

Official title:

A Mobile Health Exercise Intervention for Older Patients With Myeloid Neoplasms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04035499
• Other study ID #: UCCS19090/EXCAP
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: October 31, 2021

Study information

• Verified date: April 2023
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Intervention
• Neoplasms

Intervention

Behavioral:
• GO-EXCAP Mobile App
A mobile app delivery platform and the EXCAP©® exercise program

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 Prog — View 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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility: Percentage of Patients Entering Any Exercise Data Into the Mobile App =50% of the Study Period Days, Excluding Hospitalization	Percentage of patients entering any exercise data into the mobile app =50% of the study period days, excluding hospitalization	8-12 weeks
Primary	Feasibility: Percentage of Patients Entering Resistance Data Into the Mobile App =50% of the Study Period Days, Excluding Hospitalization	Percentage of Patients Entering Resistance Data Into the Mobile App =50% of the Study Period Days, Excluding Hospitalization	8-12 weeks
Primary	Feasibility: Recruitment Rates	Recruitment rates (percentage of patients who are approached and subsequently consent).	Week 0, prior to baseline
Primary	Feasibility: Retention Rates	Retention rates (percentage of patients who are enrolled i.e., complete baseline assessments and subsequently complete post-intervention assessments)	8-12 weeks
Secondary	Pre-post Changes in Short Physical Performance Battery (SPPB)	Changes in physical function measured using the Short Physical Performance Battery (SPPB) which an objective physical assessment evaluating lower extremity physical function (total 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; scores are summed).	Baseline, Post-Intervention, Changes from baseline to post-intervention (an average of 8-12 weeks)
Secondary	Pre-post Changes in Brief Fatigue Inventory (BFI)	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 (scores are summed; total score ranges from 0-90), a higher score indicates higher self-reported levels of fatigue.	Baseline, Post-Intervention, Changes from baseline to post-intervention (an average of 8-12 weeks)
Secondary	Pre-post Changes in the Center for Epidemiological Studies Depression Scale (CES-D)	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 (scores are summed; total score ranges from 0-60), a higher score indicates higher self-reported depression levels.	8-12 weeks
Secondary	Pre-post Changes in Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu)	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 (total score ranges from 0-176). After reversing the scoring of negatively worded items, all the scores are summated. A higher score indicates better quality of life.	Baseline, Post-Intervention, Changes from baseline to post-intervention (an average of 8-12 weeks)