Intervention
Conditions
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.
Interventions
BEHAVIORALGO-EXCAP Mobile App
A mobile app delivery platform and the EXCAP©® exercise program
Sponsors
University of Rochester
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Evaluating the feasibility of a mobile health exercise intervention in older adults with myeloid neoplasms
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Percentage of Patients Entering Any Exercise Data Into the Mobile App ≥50% of the Study Period Days, Excluding Hospitalization | 8-12 weeks | Percentage of patients entering any exercise data into the mobile app ≥50% of the study period days, excluding hospitalization |
| Feasibility: Percentage of Patients Entering Resistance Data Into the Mobile App ≥50% of the Study Period Days, Excluding Hospitalization | 8-12 weeks | Percentage of Patients Entering Resistance Data Into the Mobile App ≥50% of the Study Period Days, Excluding Hospitalization |
| Feasibility: Recruitment Rates | Week 0, prior to baseline | Recruitment rates (percentage of patients who are approached and subsequently consent). |
| Feasibility: Retention Rates | 8-12 weeks | Retention rates (percentage of patients who are enrolled i.e., complete baseline assessments and subsequently complete post-intervention assessments) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pre-post Changes in Short Physical Performance Battery (SPPB) | Baseline, Post-Intervention, Changes from baseline to post-intervention (an average of 8-12 weeks) | 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). |
| Pre-post Changes in Brief Fatigue Inventory (BFI) | Baseline, Post-Intervention, Changes from baseline to post-intervention (an average of 8-12 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 (scores are summed; total score ranges from 0-90), a higher score indicates higher self-reported levels of fatigue. |
| Pre-post Changes in the Center for Epidemiological Studies Depression Scale (CES-D) | 8-12 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 (scores are summed; total score ranges from 0-60), a higher score indicates higher self-reported depression levels. |
| Pre-post Changes in Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) | Baseline, Post-Intervention, Changes from baseline to post-intervention (an average of 8-12 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 (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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKah Poh Loh
University of Rochester
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental Arm:single GO-EXCAP Mobile App involves the use of a mobile app delivery platform to deliver an exercise program \[Exercise for Cancer Patients (EXCAP©®)\]. EXCAP©® is a progressive walking and resistance exercise program
GO-EXCAP Mobile App: A mobile app delivery platform and the EXCAP©® exercise program | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Experimental Arm:single |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 24 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | 72 years STANDARD_DEVIATION 4.9 |
| Brief Fatigue Inventory at Baseline | 29.4 score on a scale STANDARD_DEVIATION 20.8 |
| Center for Epidemiologic Studies Depression at Baseline | 11.7 score on a scale STANDARD_DEVIATION 7.7 |
| Functional Assessment of Cancer Therapy-Leukemia at Baseline | 123.9 score on a scale STANDARD_DEVIATION 24.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 17 Participants |
| Short Physical Performance Battery at Baseline | 9.0 score on a scale STANDARD_DEVIATION 1.7 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
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
Time frame: 8-12 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental Arm:single | Feasibility: Percentage of Patients Entering Any Exercise Data Into the Mobile App ≥50% of the Study Period Days, Excluding Hospitalization | % Entering Step Data | 18 Participants |
| Experimental Arm:single | Feasibility: Percentage of Patients Entering Any Exercise Data Into the Mobile App ≥50% of the Study Period Days, Excluding Hospitalization | % Entering Resistance Data | 14 Participants |
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
Time frame: 8-12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental Arm:single | Feasibility: Percentage of Patients Entering Resistance Data Into the Mobile App ≥50% of the Study Period Days, Excluding Hospitalization | 14 Participants |
Primary
Feasibility: Recruitment Rates
Recruitment rates (percentage of patients who are approached and subsequently consent).
Time frame: Week 0, prior to baseline
Population: Number of potential subjects determined eligible and approached to consent. Patients who consented and subsequently withdrew before baseline assessments also contributed to the numerator.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental Arm:single | Feasibility: Recruitment Rates | 38 Participants |
Primary
Feasibility: Retention Rates
Retention rates (percentage of patients who are enrolled i.e., complete baseline assessments and subsequently complete post-intervention assessments)
Time frame: 8-12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental Arm:single | Feasibility: Retention Rates | 22 Participants |
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.
Time frame: Baseline, Post-Intervention, Changes from baseline to post-intervention (an average of 8-12 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Arm:single | Pre-post Changes in Brief Fatigue Inventory (BFI) | Baseline | 29.4 score on a scale | Standard Deviation 20.8 |
| Experimental Arm:single | Pre-post Changes in Brief Fatigue Inventory (BFI) | Post-Intervention | 23.2 score on a scale | Standard Deviation 18.8 |
| Experimental Arm:single | Pre-post Changes in Brief Fatigue Inventory (BFI) | Changes from baseline to post | -6.2 score on a scale | Standard Deviation 17.9 |
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.
Time frame: Baseline, Post-Intervention, Changes from baseline to post-intervention (an average of 8-12 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Arm:single | Pre-post Changes in Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) | Baseline | 123.9 score on a scale | Standard Deviation 24.7 |
| Experimental Arm:single | Pre-post Changes in Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) | Post-Intervention | 127.1 score on a scale | Standard Deviation 22.9 |
| Experimental Arm:single | Pre-post Changes in Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) | Changes from baseline to post | 3.2 score on a scale | Standard Deviation 18.1 |
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).
Time frame: Baseline, Post-Intervention, Changes from baseline to post-intervention (an average of 8-12 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Arm:single | Pre-post Changes in Short Physical Performance Battery (SPPB) | Baseline | 9.0 score on a scale | Standard Deviation 1.7 |
| Experimental Arm:single | Pre-post Changes in Short Physical Performance Battery (SPPB) | Post-Intervention | 9.2 score on a scale | Standard Deviation 2.4 |
| Experimental Arm:single | Pre-post Changes in Short Physical Performance Battery (SPPB) | Changes from baseline to post | 0.2 score on a scale | Standard Deviation 1.6 |
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.
Time frame: 8-12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Arm:single | Pre-post Changes in the Center for Epidemiological Studies Depression Scale (CES-D) | Baseline | 11.7 score on a scale | Standard Deviation 7.7 |
| Experimental Arm:single | Pre-post Changes in the Center for Epidemiological Studies Depression Scale (CES-D) | Post-Intervention | 11.1 score on a scale | Standard Deviation 8 |
| Experimental Arm:single | Pre-post Changes in the Center for Epidemiological Studies Depression Scale (CES-D) | Changes from Baseline to Post | -0.6 score on a scale | Standard Deviation 6.1 |