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

ConditionsCancer Myeloid Neoplasm

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age60+

SponsorUniversity of Rochester

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

170 Participants

are divided into 2 treatment groups

Group A: GO-EXCAPExperimental treatment 1 intervention

Group B: Behavioral Placebo ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

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).

Time frame

12 Weeks

Secondary outcomes

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.

Time frame

12 Weeks

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.

Time frame

12 Weeks

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.

Time frame

12 Weeks

Other outcomes

Difference between experimental and active comparator arms -Inflammatory cytokines

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

Time frame

12 Weeks

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

DNA methylation in the TNFα promoter region

Time frame

12 Weeks

Difference between experimental and active comparator arms- TNFα gene expression

TNFα gene expression by PCR

Time frame

12 Weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Rochester

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

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