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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm:single | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GO-EXCAP Mobile App | Behavioral | A mobile app delivery platform and the EXCAP©® exercise program |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Feasibility: Recruitment Rates | Recruitment rates (percentage of patients who are approached and subsequently consent). | Week 0, prior to baseline |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
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)
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| Name | Affiliation | Role |
|---|---|---|
| Kah Poh Loh | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31034591 | Result | 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 Program on Anxiety and Mood Disturbances in Older Adults with Cancer Receiving Chemotherapy. J Am Geriatr Soc. 2019 May;67(5):1005-1011. doi: 10.1111/jgs.15951. | |
| 30373733 |
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A complete and final study protocol will be made publicly available through the University of Rochester Cancer Center Community Oncology Research Program Research Base Protocol and Data Sharing Committee. The full protocol and data will be made publicly available no later than the publication date of the study findings from the final dataset. The protocol will include a detailed description of the study population, hypotheses tested, measurement and assessment information, data definitions and codes, and the analysis plan utilized. We will also make this protocol available to NIH and NCI at the time of submission of each progress report and at the end of the final funding year. We will be collecting identifying information. The final dataset will be stripped of identifiers prior to release for sharing.Published papers will be made available in portable document format.
The data will be available for 7 years after study completion.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Older adults aged 60 and over
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 8-12 weeks |
|
|
8-12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kah Poh Loh | University of Rochester Medical Center | 585-276-4353 | kahpoh_loh@urmc.rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 22, 2021 | Feb 9, 2023 | Prot_SAP_000.pdf |
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Evaluating the feasibility of a mobile health exercise intervention in older adults with myeloid neoplasms
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| Baseline, Post-Intervention, Changes from baseline to post-intervention (an average of 8-12 weeks) |
| 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) |
| 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 |
| 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) |
| Result |
| 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: Pilot Feasibility and Usability Study. JMIR Cancer. 2018 Oct 29;4(2):e10296. doi: 10.2196/10296. |
| 39789445 | Derived | Jensen-Battaglia M, Lin PJ, Sanapala C, Watson EE, Mendler JH, Liesveld J, Wang Y, Hayward E, LoCastro M, Mortaz S, Dunne RF, Mustian K, Loh KP. Changes in muscle performance among older adults with myeloid malignancies engaging in a mobile health (mHealth) exercise intervention: a single arm pilot study. BMC Geriatr. 2025 Jan 9;25(1):22. doi: 10.1186/s12877-024-05668-w. |
| 37698745 | Derived | Wang K, Consagra W, Jensen-Battaglia M, Kleckner A, Kleckner IR, Loh KP. Chemotherapy-related symptoms and exercise adherence in older patients with myeloid neoplasms. Support Care Cancer. 2023 Sep 12;31(10):572. doi: 10.1007/s00520-023-08039-0. |
| 35320340 | Derived | Loh KP, Sanapala C, Watson EE, Jensen-Battaglia M, Janelsins MC, Klepin HD, Schnall R, Culakova E, Vertino P, Susiarjo M, Lin PJ, Mendler JH, Liesveld JL, Huselton EJ, Taberner K, Mohile SG, Mustian K. A single-arm pilot study of a mobile health exercise intervention (GO-EXCAP) in older patients with myeloid neoplasms. Blood Adv. 2022 Jul 12;6(13):3850-3860. doi: 10.1182/bloodadvances.2022007056. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Short Physical Performance Battery at Baseline | 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). | Post-intervention data were not collected for 3 subjects who completed baseline (2 died, 1 withdrew) | Mean | Standard Deviation | score on a scale |
|
| Brief Fatigue Inventory at Baseline | 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. | Post-intervention data were not collected for 3 subjects who completed baseline (2 died, 1 withdrew) | Mean | Standard Deviation | score on a scale |
|
| Center for Epidemiologic Studies Depression at Baseline | 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. | Post-intervention data were not collected for 3 subjects who completed baseline | Mean | Standard Deviation | score on a scale |
|
| Functional Assessment of Cancer Therapy-Leukemia at Baseline | 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. | Measure Analysis Population Description: Post-intervention data were not collected for 3 subjects who completed baseline (2 died, 1 withdrew) | Mean | Standard Deviation | score on a scale |
|
| 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 | Posted | Count of Participants | Participants | 8-12 weeks |
|
|
|
| Primary | Feasibility: Recruitment Rates | Recruitment rates (percentage of patients who are approached and subsequently consent). | Number of potential subjects determined eligible and approached to consent. Patients who consented and subsequently withdrew before baseline assessments also contributed to the numerator. | Posted | Count of Participants | Participants | 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) | Posted | Count of Participants | Participants | 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). | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Post-Intervention, Changes from baseline to post-intervention (an average of 8-12 weeks) |
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| 2 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
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