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NCT Number: NCT04981821

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

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.

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Key information

Conditions

Cancer Myeloid Neoplasm Neoplasms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Medical Center/Wilmot Cancer Institute

Rochester, New York, 14642, United States

Location status: Recruiting

Location contact

Kah Poh Loh, MBBCh BAO, MS

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GO-EXCAP Mobile App

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

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.

Primary outcomes

  1. Difference between experimental and active comparator arms- Physical Function

    Time frame: 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 outcomes

  1. Difference between experimental and active comparator arms -Fatigue

    Time frame: 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.

  2. Difference between experimental and active comparator arms -Depression

    Time frame: 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.

  3. Difference between experimental and active comparator arms -Quality of Life

    Time frame: 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.

Other outcomes

  1. Difference between experimental and active comparator arms -Inflammatory cytokines

    Time frame: 12 Weeks

    Inflammatory cytokines including TNFα, sTNFR1, sTNFR2, IL-1β, IL-2, IL-6, sIL-6R, IL-8, IL-10

  2. Difference between experimental and active comparator arms- DNA methylation in the TNFα promoter region

    Time frame: 12 Weeks

    DNA methylation in the TNFα promoter region

  3. Difference between experimental and active comparator arms- TNFα gene expression

    Time frame: 12 Weeks

    TNFα gene expression by PCR

Study contacts

Contact information is provided by the study sponsor or research team.

Becky Gravenstede

CONTACT

[email protected]

585-727-4728

Kah Poh Loh

CONTACT

[email protected]

585-275-5863

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: GO-EXCAP2

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jul 29, 2021
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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