Acute Leukemia in RemissionNCT03574012
SmART Heart: Study of mHealth Apps to Reduce Cancer-Treatment Effects on the Heart
A study testing Monitoring Device, Informational Intervention and Questionnaire Administration in people with Acute Leukemia in Remission and Hematopoietic Cell Transplantation Recipient, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This pilot trial studies how well education and mobile health applications work in reducing the effects of cancer treatment on the heart in participants with blood cancers that are in remission. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Acute Leukemia in Remission, Hematopoietic Cell Transplantation Recipient, Lymphoma
- What is being tested?
- Monitoring Device, Informational Intervention and Questionnaire Administration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2018to 16 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Prior diagnosis of an acute leukemia or lymphoma or any receipt of HCT for a malignant condition.
- At time of approach, >= 5 years from initial cancer diagnosis or >= 5 years from first HCT, whichever is later.
- Currently in remission and not on any active anti-cancer therapies (survivors receiving maintenance tyrosine kinase inhibitors are NOT eligible).
- Able to read, write, and speak English.
- Access to smart phone or computer with internet access.
- Presence of at least 1 CV risk factor:
Show all 12Show fewer
- Currently on medication for hypertension, or
- Currently on medication for cholesterol or triglyceride, or
- Currently on medication for diabetes, or
- Currently not physically active (self-reported average < 30 minutes/day), or
- Currently smoking.
- Ability to understand and the willingness to provide informed consent.
Who cannot join
- Pre-existing ischemic heart disease (includes angina if documented in electronic medical record [EMR]) or ongoing symptomatic cardiomyopathy (those with asymptomatic cardiomyopathy may be allowed to participate if they do not have any current activity restrictions, but we will seek physician clearance for any submaximal exercise testing).
- Active systemic treatment for graft versus host disease.
- Currently pregnant. However, participants enrolled who become pregnant after randomization can remain on the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
This pilot trial studies how well education and mobile health applications work in reducing the effects of cancer treatment on the heart in participants with blood cancers that are in remission. Education and mobile health applications may be effective ways to manage heart health and to reduce future heart disease risk in participants with blood cancers.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the feasibility of recruiting and retaining hematologic malignancy and hematopoietic cell transplantation (HCT) survivors in a randomized cardiovascular (CV) risk reduction mobile health (mHealth) counseling intervention.
II. Develop and refine a protocol to engage participants using an existing social medial platform and commercially available mHealth tools to reinforce lifestyle goals.
OUTLINE: Participants are randomized to 1 of 2 groups.
INTERVENTION GROUP: Participants receive individualized goal-setting and coaching in relation to physical activity and diet, supplemented with peer support through the study's social media platform, over 4 months. They also have access to mHealth apps including Fitbit and Healthwatch that provide feedback on physical activity and diet.
CONTROL GROUP: Participants receive general information about physical activity and diet, and access to Fitbit and Healthwatch.
After completion of study treatment, participants are followed up at 2 months and at 1 year.
- Being tested
- Monitoring Device, Informational Intervention, Questionnaire Administration
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring DeviceDevice
Use Fitbit tracker
Informational InterventionOther
Receive individualized health and fitness information from clinician, supplemented with peer support through the study's social media platform
Informational InterventionOther
Receive general health and fitness information from clinician
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Control Group (general health information, fitness tracker) | Active comparator | Participants receive general information about physical activity and diet, and access to Fitbit and Healthwatch. Receives: Device: Monitoring Device; Other: Informational Intervention; Other: Questionnaire Administration |
| Intervention Group (individualized information, tracker) | Experimental | Participants receive individualized goal-setting and coaching in relation to physical activity and diet, supplemented with peer support through the study's social media platform, over 4 months. They also have access to mHealth apps including Fitbit and Healthwatch that provide feedback on physical activity and diet. Receives: Device: Monitoring Device; Other: Informational Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rate among participants approached
Measured: Up to 1 year
Retention rate among participants enrolled
Retention is defined as completion of patient questionnaire and in-person assessment after 4-month intervention
Measured: Up to 1 year
Participation in Facebook group
Number of participants who log onto the group page and participate at least one time (e.g., view a post, post something themselves, respond to a post [e.g., "like" a post], etc.)
Measured: Up to 1 year
Participation in Fitbit physical activity tracking
Number of participants who submit step count data on at least 50% of eligible days
Measured: Up to 1 year
Participation in Healthwatch diet tracking
Number of participants who provide dietary data on at least 75% of eligible days
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start31 Aug 2018
- Primary completion22 Jan 2020
- Study completion16 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Leukemia in RemissionStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Eric Chow, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574012
- Sponsor's protocol ID
- 10037
- Other IDs
- NCI-2018-01168, 10037, P30CA015704, RG1001769
- Status last verified
- Sep 2020
- First submitted
- 19 Jun 2018
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chow EJ, Doody DR, Di C, Armenian SH, Baker KS, Bricker JB, Gopal AK, Hagen AM, Ketterl TG, Lee SJ, Reding KW, Schenk JM, Syrjala KL, Taylor SA, Wang G, Neuhouser ML, Mendoza JA. Feasibility of a behavioral intervention using mobile health applications to reduce cardiovascular risk factors in cancer survivors: a pilot randomized controlled trial. J Cancer Surviv. 2021 Aug;15(4):554-563. doi: 10.1007/s11764-020-00949-w. Epub 2020 Oct 10.
PubMed 33037989
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SmART Heart: Study of mHealth Apps to Reduce Cancer-Treatment Effects on the Heart
- ClinicalTrials.gov ID
- NCT03574012
- Acronym / sponsor ID
- 10037
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 31 Aug 2018 (actual)
- Primary completion
- 22 Jan 2020 (actual)
- Study completion
- 16 Jun 2020 (actual)
- First posted
- 29 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot trial studies how well education and mobile health applications work in reducing the effects of cancer treatment on the heart in participants with blood cancers that are in remission. Education and mobile health applications may be effective ways to manage heart health and to reduce future heart disease risk in participants with blood cancers.
Detailed description
PRIMARY OBJECTIVES:
- Determine the feasibility of recruiting and retaining hematologic malignancy and hematopoietic cell transplantation (HCT) survivors in a randomized cardiovascular (CV) risk reduction mobile health (mHealth) counseling intervention.
II. Develop and refine a protocol to engage participants using an existing social medial platform and commercially available mHealth tools to reinforce lifestyle goals.
OUTLINE: Participants are randomized to 1 of 2 groups.
INTERVENTION GROUP: Participants receive individualized goal-setting and coaching in relation to physical activity and diet, supplemented with peer support through the study's social media platform, over 4 months. They also have access to mHealth apps including Fitbit and Healthwatch that provide feedback on physical activity and diet.
CONTROL GROUP: Participants receive general information about physical activity and diet, and access to Fitbit and Healthwatch.
After completion of study treatment, participants are followed up at 2 months and at 1 year.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group (general health information, fitness tracker) | Active comparator | Device: Monitoring Device, Other: Informational Intervention, Other: Questionnaire AdministrationParticipants receive general information about physical activity and diet, and access to Fitbit and Healthwatch. |
| Intervention Group (individualized information, tracker) | Experimental | Device: Monitoring Device, Other: Informational Intervention, Other: Questionnaire AdministrationParticipants receive individualized goal-setting and coaching in relation to physical activity and diet, supplemented with peer support through the study's social media platform, over 4 months. They also have access to mHealth apps including Fitbit and Healthwatch that provide feedback on physical activity and diet. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Prior diagnosis of an acute leukemia or lymphoma or any receipt of HCT for a malignant condition.
- At time of approach, >= 5 years from initial cancer diagnosis or >= 5 years from first HCT, whichever is later.
- Currently in remission and not on any active anti-cancer therapies (survivors receiving maintenance tyrosine kinase inhibitors are NOT eligible).
- Able to read, write, and speak English.
- Access to smart phone or computer with internet access.
Key exclusion criteria (3 listed)
- Pre-existing ischemic heart disease (includes angina if documented in electronic medical record [EMR]) or ongoing symptomatic cardiomyopathy (those with asymptomatic cardiomyopathy may be allowed to participate if they do not have any current activity restrictions, but we will seek physician clearance for any submaximal exercise testing).
- Active systemic treatment for graft versus host disease.
- Currently pregnant. However, participants enrolled who become pregnant after randomization can remain on the study.
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 |
|---|---|---|
| Monitoring DeviceUse Fitbit tracker | Device | Control Group (general health information, fitness tracker), Intervention Group (individualized information, tracker) |
| Informational InterventionReceive individualized health and fitness information from clinician, supplemented with peer support through the study's social media platform | Other | Intervention Group (individualized information, tracker) |
| Informational InterventionReceive general health and fitness information from clinician | Other | Control Group (general health information, fitness tracker) |
| Questionnaire AdministrationAncillary studies | Other | Control Group (general health information, fitness tracker), Intervention Group (individualized information, tracker) |
Primary outcome
Enrollment rate among participants approached
Time frame: Up to 1 year
Retention rate among participants enrolled
Time frame: Up to 1 year
Retention is defined as completion of patient questionnaire and in-person assessment after 4-month intervention
Participation in Facebook group
Time frame: Up to 1 year
Number of participants who log onto the group page and participate at least one time (e.g., view a post, post something themselves, respond to a post [e.g., "like" a post], etc.)
Participation in Fitbit physical activity tracking
Time frame: Up to 1 year
Number of participants who submit step count data on at least 50% of eligible days
Participation in Healthwatch diet tracking
Time frame: Up to 1 year
Number of participants who provide dietary data on at least 75% of eligible days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Results publication: PubMed 33037989Chow EJ, Doody DR, Di C, Armenian SH, Baker KS, Bricker JB, Gopal AK, Hagen AM, Ketterl TG, Lee SJ, Reding KW, Schenk JM, Syrjala KL, Taylor SA, Wang G, Neuhouser ML, Mendoza JA. Feasibility of a behavioral intervention using mobile health applications to reduce cardiovascular risk factors in cancer survivors: a pilot randomized controlled trial. J Cancer Surviv. 2021 Aug;15(4):554-563. doi: 10.1007/s11764-020-00949-w. Epub 2020 Oct 10.
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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.
Eric Chow principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring Device, Informational Intervention and Questionnaire Administration in people with Acute Leukemia in Remission and Hematopoietic Cell Transplantation Recipient, run by Fred Hutchinson Cancer Center 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 12 inclusion and 3 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 23 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Enrollment rate among participants approached (time frame: Up to 1 year). The study lists 5 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 NCT03574012, which also lists 1 linked publication.
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 23 Jan 2024.