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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01168 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 10037 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| P30CA015704 | U.S. NIH Grant/Contract | View source | |
| RG1001769 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group (general health information, fitness tracker) | Active Comparator | Participants receive general information about physical activity and diet, and access to Fitbit and Healthwatch. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monitoring Device | Device | Use Fitbit tracker |
|
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment rate among participants approached | 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 | 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.) | 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 | Up to 1 year |
| Participation in Healthwatch diet tracking | Number of participants who provide dietary data on at least 75% of eligible days | Up to 1 year |
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Inclusion Criteria:
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:
Ability to understand and the willingness to provide informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Chow | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33037989 | Result | 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. |
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| Informational Intervention | Other | Receive individualized health and fitness information from clinician, supplemented with peer support through the study's social media platform |
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| Informational Intervention | Other | Receive general health and fitness information from clinician |
|
| Questionnaire Administration | Other | Ancillary studies |
|
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D008991 | Monitoring, Physiologic |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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