A Randomized Trial of a Mobile Health Exercise Intervention for Older Adults With Myeloid Neoplasms

Cancer Clinical Trial

— GO-EXCAP2  

Official title:

A Pilot Randomized Trial of a Mobile Health Exercise Intervention for Older Adults With Myeloid Neoplasms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04981821
• Other study ID #: UCCS21043
• Secondary ID: R00CA237744
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: University of Rochester
• Contact: Kah Poh Loh
• Phone: 585-275-5863
• Email: kahpoh_loh[@]urmc.rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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 (patients 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 patient's ability to participate in the study or participate in the intervention, as determined by the PI or the treating team

Related Conditions & MeSH terms

• Cancer
• Myeloid Neoplasm
• Neoplasms

Intervention

Behavioral:
• GO-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
• Behavioral 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.

Locations

Country	Name	City	State
United States	University of Rochester Medical Center/Wilmot Cancer Institute	Rochester	New York

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Difference between experimental and active comparator arms -Inflammatory cytokines	Inflammatory cytokines including TNFa, sTNFR1, sTNFR2, IL-1ß, IL-2, IL-6, sIL-6R, IL-8, IL-10	12 Weeks
Other	Difference between experimental and active comparator arms- DNA methylation in the TNFa promoter region	DNA methylation in the TNFa promoter region	12 Weeks
Other	Difference between experimental and active comparator arms- TNFa gene expression	TNFa gene expression by PCR	12 Weeks
Primary	Difference between experimental and active comparator arms- Physical Function	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).	12 Weeks
Secondary	Difference between experimental and active comparator arms -Fatigue	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.	12 Weeks
Secondary	Difference between experimental and active comparator arms -Depression	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.	12 Weeks
Secondary	Difference between experimental and active comparator arms -Quality of Life	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.	12 Weeks