InterventionGO-EXCAPNCT04035499
A Mobile Health Exercise Intervention for Older Patients With Myeloid Neoplasms
A study testing GO-EXCAP Mobile App in people with Intervention, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Intervention
- What is being tested?
- GO-EXCAP Mobile App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
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.
Read the 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.
- Conditions
- Intervention
- Being tested
- GO-EXCAP Mobile App
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GO-EXCAP Mobile AppBehavioural
A mobile app delivery platform and the EXCAP©® exercise program
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: GO-EXCAP Mobile App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 8-12 weeks
Feasibility: Recruitment Rates
Recruitment rates (percentage of patients who are approached and subsequently consent).
Measured: 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)
Measured: 8-12 weeks
Secondary outcomes (4)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Post-Intervention, Changes from baseline to post-intervention (an average of 8-12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start1 Feb 2020
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for InterventionStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Evaluating the feasibility of a mobile health exercise intervention in older adults with myeloid neoplasms
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Kah Poh Loh, University of Rochester
- Investigators
- Kah Poh Loh, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035499
- Sponsor's protocol ID
- UCCS19090
- Acronym
- GO-EXCAP
- Status last verified
- Mar 2026
- First submitted
- 24 Jul 2019
- Last updated
- 31 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 31034591Loh 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.
PubMed 30373733Jensen-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.
PubMed 39789445Wang 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.
PubMed 37698745Loh 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.
PubMed 35320340
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Health Exercise Intervention for Older Patients With Myeloid Neoplasms
- ClinicalTrials.gov ID
- NCT04035499
- Acronym / sponsor ID
- GO-EXCAP / UCCS19090
- Conditions
- Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 29 Jul 2019 (actual)
- Results
- Posted 3 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Evaluating the feasibility of a mobile health exercise intervention in older adults with myeloid neoplasms
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm:single | Experimental | Behavioral: GO-EXCAP Mobile AppGO-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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GO-EXCAP Mobile AppA mobile app delivery platform and the EXCAP©® exercise program | Behavioural | Experimental Arm:single |
Primary outcome
Feasibility: Percentage of Patients Entering Any Exercise Data Into the Mobile App ≥50% of the Study Period Days, Excluding Hospitalization
Time frame: 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
Time frame: 8-12 weeks
Percentage of Patients Entering Resistance Data Into the Mobile App ≥50% of the Study Period Days, Excluding Hospitalization
Feasibility: Recruitment Rates
Time frame: Week 0, prior to baseline
Recruitment rates (percentage of patients who are approached and subsequently consent).
Feasibility: Retention Rates
Time frame: 8-12 weeks
Retention rates (percentage of patients who are enrolled i.e., complete baseline assessments and subsequently complete post-intervention assessments)
4 secondary outcomes
Pre-post Changes in Short Physical Performance Battery (SPPB)
Time frame: Baseline, Post-Intervention, Changes from baseline to post-intervention (an average of 8-12 weeks)
Pre-post Changes in Brief Fatigue Inventory (BFI)
Time frame: 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)
Time frame: 8-12 weeks
Pre-post Changes in Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu)
Time frame: Baseline, Post-Intervention, Changes from baseline to post-intervention (an average of 8-12 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31034591Loh 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.
- Results publication: PubMed 30373733Loh 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.
- Derived from this study: PubMed 39789445Jensen-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.
- Derived from this study: PubMed 37698745Wang 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.
- Derived from this study: PubMed 35320340Loh 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kah Poh Loh principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GO-EXCAP Mobile App in people with Intervention, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Percentage of Patients Entering Any Exercise Data Into the Mobile App ≥50% of the Study Period Days, Excluding Hospitalization (time frame: 8-12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04035499, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.