Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-31 @ 8:30 PM
Study NCT ID:
NCT03574012
Status:
COMPLETED
Last Update Posted:
2024-01-23
First Post:
2018-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SmART Heart: Study of mHealth Apps to Reduce Cancer-Treatment Effects on the Heart
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Study Overview
Official Title:
SmART Heart: Study of mHealth Apps to Reduce Cancer-Treatment Effects on the Heart
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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:
I. 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.
I. 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2018-01168 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 10037 | OTHER | Fred Hutch/University of Washington Cancer Consortium | View | |
| P30CA015704 | NIH | None | https://reporter.nih.gov/quic… | View |
| RG1001769 | OTHER | Fred Hutch/University of Washington Cancer Consortium | View |