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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00165192 | Other Identifier | University of Michigan | |
| HUM00186436 | Other Identifier | University of Michigan | |
| R01HL146354 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Department of Health and Human Services | FED |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The purpose of this research study is to measure the effects of using a mobile phone app (Roadmap 2.0) on the health-related quality of life of caregivers and patients undergoing allogeneic/autologous hematopoietic cell transplantation (HCT).
Health information technology tools may enable caregivers and patients to become more active participants in their healthcare.This study is not to provide any treatment, but rather to investigate the use of this mobile health technology-mediated intervention (Roadmap 2.0). Roadmap 2.0 is a web-based application that integrates patient-specific information and includes several domains: laboratory results, medications, clinical trial details, photos of the healthcare team, trajectory of transplant process, and discharge checklist.
This trial is anticipated to enroll 664 participants, but only caregivers (332 total) will be evaluated for the primary and secondary outcome measures. Thus, the sample size is 332. The total enrollment includes 166 caregiver-patient dyads of adult patients (age >/=18 years) undergoing HCT ("adult dyads" = 332 total) and 166 caregiver-patient dyads of pediatric patients (age 5-17 years) undergoing HCT ("pediatric dyads" = 332 total).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Roadmap 2.0 | Active Comparator | Roadmap 2.0 mobile app + wearable sensor to track activity and sleep + usual care (informational or educational resources provided through verbal communication or written hand-out materials). Includes caregivers of adult patients and caregivers of pediatric patients |
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| Roadmap 2.0 with Positive Activities | Experimental | Roadmap 2.0 mobile app (patients), Roadmap 2.0 with mobile Positive Activities app (caregivers) + wearable sensor to track activity and sleep + usual care (informational or educational resources provided through verbal communication or written hand-out materials). Includes caregivers of adult patients and caregivers of pediatric patients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearable activity sensor | Other | Caregivers and patients in both arms of the study will have a Fitbit wearable activity sensor to track activity and sleep. |
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| Measure | Description | Time Frame |
|---|---|---|
| Caregiver Health-related Quality of Life (HRQOL) Assessed by the PROMIS Global Health Scale. | Mean Global Health scores for each arm at day 120. PROMIS® instruments are scored using item-level calibrations. This method of scoring uses "response pattern scoring," which uses responses to each item for each participant. Scores generally range from 20 to 80, with higher scores indicating better health. | At day 120 post-transplant |
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| Measure | Description | Time Frame |
|---|---|---|
| Caregiver Health-related Quality of Life (HRQOL) Assessed by PROMIS Profile 29+2 (Exploratory) | Mean Profile 29+2 scores for each arm at day 120. PROMIS® instruments are scored using item-level calibrations. This method of scoring uses "response pattern scoring," which uses responses to each item for each participant. This is an exploratory measure. | At day 120 post-transplant |
Inclusion Criteria
Exclusion Criteria
- Patient does not meet eligibility criteria to undergo HCT at the U-M BMT Program or Oregon Health & Sciences University.
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| Name | Affiliation | Role |
|---|---|---|
| Sung Won Choi, MD, MS | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | United States | ||
| Oregon Health & Science University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40822733 | Derived | Cao X, Rozwadowski M, Braun TM, Carlozzi NE, Hassett AL, Johnson AK, Shereck E, Hanauer DA, Choi SW. A Mobile Health Intervention in Caregivers of Patients Undergoing Hematopoietic Cell Transplantation: A Randomized Controlled Trial to Examine Health-Related Quality of Life. BMC Digit Health. 2025;3(1):22. doi: 10.1186/s44247-025-00165-5. Epub 2025 Jul 15. | |
| 37651172 | Derived | Caparso C, Ozkan G, Kluge M, Salim H, Khaghany A, Blok A, Choi SW. Mobile Technology to Monitor and Support Health and Well-Being: Qualitative Study of Perspectives and Design Suggestions From Patients Undergoing Hematopoietic Cell Transplantation. JMIR Form Res. 2023 Aug 31;7:e49806. doi: 10.2196/49806. |
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Caregiver- Patient dyads were enrolled and reported as individual participants
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| ID | Title | Description |
|---|---|---|
| FG000 | Roadmap 2.0 - Patients | Roadmap 2.0 mobile app + wearable sensor to track activity and sleep + usual care (informational or educational resources provided through verbal communication or written hand-out materials). Wearable activity sensor: Caregivers and patients in both arms of the study will have a Fitbit wearable activity sensor to track activity and sleep. Roadmap 2.0 information system: Caregivers and patients download the Roadmap 2.0 app on their mobile phones or tablets Survey administration: Caregivers and patients will be asked to respond to survey questions at 3 timepoints. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 1, 2022 |
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| Roadmap 2.0 information system | Behavioral | Caregivers and patients download the Roadmap 2.0 app on their mobile phones or tablets |
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| Survey administration | Other | Caregivers and patients will be asked to respond to survey questions at 3 timepoints. |
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| Roadmap 2.0 information system with Positive Activities | Behavioral | Caregivers and patients download the Roadmap 2.0 app on their mobile phones. Caregivers and patients will be instructed on how to operate Roadmap 1.0 on an iPad (inpatient only) and Roadmap 2.0 on a mobile phone (inpatient and outpatient). Caregivers download the Positive Activities app onto their mobile phone to use freely throughout inpatient and outpatient (through day 120 post-transplant). Caregiver may also use an electronic tablet provided by the study team during the patient's hospital stay. |
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| Portland |
| Oregon |
| 97239 |
| United States |
| 32945777 | Derived | Rozwadowski M, Dittakavi M, Mazzoli A, Hassett AL, Braun T, Barton DL, Carlozzi N, Sen S, Tewari M, Hanauer DA, Choi SW. Promoting Health and Well-Being Through Mobile Health Technology (Roadmap 2.0) in Family Caregivers and Patients Undergoing Hematopoietic Stem Cell Transplantation: Protocol for the Development of a Mobile Randomized Controlled Trial. JMIR Res Protoc. 2020 Sep 18;9(9):e19288. doi: 10.2196/19288. |
| FG001 | Roadmap 2.0 - Caregivers | Roadmap 2.0 mobile app + wearable sensor to track activity and sleep + usual care (informational or educational resources provided through verbal communication or written hand-out materials). Includes caregivers of adult patients and caregivers of pediatric patients Wearable activity sensor: Caregivers and patients will have a Fitbit wearable activity sensor to track activity and sleep. Roadmap 2.0 information system: Caregivers and patients download the Roadmap 2.0 app on their mobile phones or tablets Survey administration: Caregivers and patients will be asked to respond to survey questions at 3 timepoints. |
| FG002 | Roadmap 2.0 With Positive Activities - Patients | Roadmap 2.0 mobile app (patients), Roadmap 2.0 with mobile Positive Activities app (caregivers) + wearable sensor to track activity and sleep + usual care (informational or educational resources provided through verbal communication or written hand-out materials). Includes caregivers of adult patients and caregivers of pediatric patients Wearable activity sensor: Caregivers and patients in both arms of the study will have a Fitbit wearable activity sensor to track activity and sleep. Survey administration: Caregivers and patients will be asked to respond to survey questions at 3 timepoints. Roadmap 2.0 information system with Positive Activities: Caregivers and patients download the Roadmap 2.0 app on their mobile phones. Caregivers and patients will be instructed on how to operate Roadmap 1.0 on an iPad (inpatient only) and Roadmap 2.0 on a mobile phone (inpatient and outpatient). Caregivers download the Positive Activities app onto their mobile phone to use freely throughout inpatient and outpatient (through day 120 post-transplant). Caregiver may also use an electronic tablet provided by the study team during the patient's hospital stay. |
| FG003 | Roadmap 2.0 With Positive Activities - Caregivers | Roadmap 2.0 mobile app (patients), Roadmap 2.0 with mobile Positive Activities app (caregivers) + wearable sensor to track activity and sleep + usual care (informational or educational resources provided through verbal communication or written hand-out materials). Includes caregivers of adult patients and caregivers of pediatric patients Wearable activity sensor: Caregivers and patients in both arms of the study will have a Fitbit wearable activity sensor to track activity and sleep. Survey administration: Caregivers and patients will be asked to respond to survey questions at 3 timepoints. Roadmap 2.0 information system with Positive Activities: Caregivers and patients download the Roadmap 2.0 app on their mobile phones. Caregivers and patients will be instructed on how to operate Roadmap 1.0 on an iPad (inpatient only) and Roadmap 2.0 on a mobile phone (inpatient and outpatient). Caregivers download the Positive Activities app onto their mobile phone to use freely throughout inpatient and outpatient (through day 120 post-transplant). Caregiver may also use an electronic tablet provided by the study team during the patient's hospital stay. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Roadmap 2.0 - Patients | Roadmap 2.0 mobile app + wearable sensor to track activity and sleep + usual care (informational or educational resources provided through verbal communication or written hand-out materials). Includes caregivers of adult patients and caregivers of pediatric patients Wearable activity sensor: Caregivers and patients in both arms of the study will have a Fitbit wearable activity sensor to track activity and sleep. Roadmap 2.0 information system: Caregivers and patients download the Roadmap 2.0 app on their mobile phones or tablets Survey administration: Caregivers and patients will be asked to respond to survey questions at 3 timepoints. |
| BG001 | Roadmap 2.0 - Caregivers | Roadmap 2.0 mobile app + wearable sensor to track activity and sleep + usual care (informational or educational resources provided through verbal communication or written hand-out materials). Includes caregivers of adult patients and caregivers of pediatric patients Wearable activity sensor: Caregivers and patients in both arms of the study will have a Fitbit wearable activity sensor to track activity and sleep. Roadmap 2.0 information system: Caregivers and patients download the Roadmap 2.0 app on their mobile phones or tablets Survey administration: Caregivers and patients will be asked to respond to survey questions at 3 timepoints. |
| BG002 | Roadmap 2.0 With Positive Activities - Patients | Roadmap 2.0 mobile app (patients), Roadmap 2.0 with mobile Positive Activities app (caregivers) + wearable sensor to track activity and sleep + usual care (informational or educational resources provided through verbal communication or written hand-out materials). Includes caregivers of adult patients and caregivers of pediatric patients Wearable activity sensor: Caregivers and patients in both arms of the study will have a Fitbit wearable activity sensor to track activity and sleep. Survey administration: Caregivers and patients will be asked to respond to survey questions at 3 timepoints. Roadmap 2.0 information system with Positive Activities: Caregivers and patients download the Roadmap 2.0 app on their mobile phones. Caregivers and patients will be instructed on how to operate Roadmap 1.0 on an iPad (inpatient only) and Roadmap 2.0 on a mobile phone (inpatient and outpatient). Caregivers download the Positive Activities app onto their mobile phone to use freely throughout inpatient and outpatient (through day 120 post-transplant). Caregiver may also use an electronic tablet provided by the study team during the patient's hospital stay. |
| BG003 | Roadmap 2.0 With Positive Activities - Caregivers | Roadmap 2.0 mobile app (patients), Roadmap 2.0 with mobile Positive Activities app (caregivers) + wearable sensor to track activity and sleep + usual care (informational or educational resources provided through verbal communication or written hand-out materials). Includes caregivers of adult patients and caregivers of pediatric patients Wearable activity sensor: Caregivers and patients in both arms of the study will have a Fitbit wearable activity sensor to track activity and sleep. Survey administration: Caregivers and patients will be asked to respond to survey questions at 3 timepoints. Roadmap 2.0 information system with Positive Activities: Caregivers and patients download the Roadmap 2.0 app on their mobile phones. Caregivers and patients will be instructed on how to operate Roadmap 1.0 on an iPad (inpatient only) and Roadmap 2.0 on a mobile phone (inpatient and outpatient). Caregivers download the Positive Activities app onto their mobile phone to use freely throughout inpatient and outpatient (through day 120 post-transplant). Caregiver may also use an electronic tablet provided by the study team during the patient's hospital stay. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | |||||||||||||||||||||||
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| Primary | Caregiver Health-related Quality of Life (HRQOL) Assessed by the PROMIS Global Health Scale. | Mean Global Health scores for each arm at day 120. PROMIS® instruments are scored using item-level calibrations. This method of scoring uses "response pattern scoring," which uses responses to each item for each participant. Scores generally range from 20 to 80, with higher scores indicating better health. | Caregivers only | Posted | Mean | Standard Deviation | score on a scale | At day 120 post-transplant |
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| Other Pre-specified | Caregiver Health-related Quality of Life (HRQOL) Assessed by PROMIS Profile 29+2 (Exploratory) | Mean Profile 29+2 scores for each arm at day 120. PROMIS® instruments are scored using item-level calibrations. This method of scoring uses "response pattern scoring," which uses responses to each item for each participant. This is an exploratory measure. | Not Posted | At day 120 post-transplant | Participants |
No Adverse Events occurred during the trial. Patients were evaluated for 4 years
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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 | Roadmap 2.0 - Patients | Roadmap 2.0 mobile app + wearable sensor to track activity and sleep + usual care (informational or educational resources provided through verbal communication or written hand-out materials). Includes caregivers of adult patients and caregivers of pediatric patients Wearable activity sensor: Caregivers and patients in both arms of the study will have a Fitbit wearable activity sensor to track activity and sleep. Roadmap 2.0 information system: Caregivers and patients download the Roadmap 2.0 app on their mobile phones or tablets Survey administration: Caregivers and patients will be asked to respond to survey questions at 3 timepoints. | 2 | 95 | 0 | 95 | 0 | 95 |
| EG001 | Roadmap 2.0 - Caregivers | Roadmap 2.0 mobile app + wearable sensor to track activity and sleep + usual care (informational or educational resources provided through verbal communication or written hand-out materials). Includes caregivers of adult patients and caregivers of pediatric patients Wearable activity sensor: Caregivers and patients in both arms of the study will have a Fitbit wearable activity sensor to track activity and sleep. Roadmap 2.0 information system: Caregivers and patients download the Roadmap 2.0 app on their mobile phones or tablets Survey administration: Caregivers and patients will be asked to respond to survey questions at 3 timepoints. | 2 | 95 | 0 | 95 | 0 | 95 |
| EG002 | Roadmap 2.0 With Positive Activities - Patients | Roadmap 2.0 mobile app (patients), Roadmap 2.0 with mobile Positive Activities app (caregivers) + wearable sensor to track activity and sleep + usual care (informational or educational resources provided through verbal communication or written hand-out materials). Includes caregivers of adult patients and caregivers of pediatric patients Wearable activity sensor: Caregivers and patients in both arms of the study will have a Fitbit wearable activity sensor to track activity and sleep. Survey administration: Caregivers and patients will be asked to respond to survey questions at 3 timepoints. Roadmap 2.0 information system with Positive Activities: Caregivers and patients download the Roadmap 2.0 app on their mobile phones. Caregivers and patients will be instructed on how to operate Roadmap 1.0 on an iPad (inpatient only) and Roadmap 2.0 on a mobile phone (inpatient and outpatient). Caregivers download the Positive Activities app onto their mobile phone to use freely throughout inpatient and outpatient (through day 120 post-transplant). Caregiver may also use an electronic tablet provided by the study team during the patient's hospital stay. | 3 | 91 | 0 | 91 | 0 | 91 |
| EG003 | Roadmap 2.0 With Positive Activities - Caregivers | Roadmap 2.0 mobile app (patients), Roadmap 2.0 with mobile Positive Activities app (caregivers) + wearable sensor to track activity and sleep + usual care (informational or educational resources provided through verbal communication or written hand-out materials). Includes caregivers of adult patients and caregivers of pediatric patients Wearable activity sensor: Caregivers and patients in both arms of the study will have a Fitbit wearable activity sensor to track activity and sleep. Survey administration: Caregivers and patients will be asked to respond to survey questions at 3 timepoints. Roadmap 2.0 information system with Positive Activities: Caregivers and patients download the Roadmap 2.0 app on their mobile phones. Caregivers and patients will be instructed on how to operate Roadmap 1.0 on an iPad (inpatient only) and Roadmap 2.0 on a mobile phone (inpatient and outpatient). Caregivers download the Positive Activities app onto their mobile phone to use freely throughout inpatient and outpatient (through day 120 post-transplant). Caregiver may also use an electronic tablet provided by the study team during the patient's hospital stay. | 3 | 91 | 0 | 91 | 0 | 91 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin | University of Michigan Rogel Cancer Center | 734-936-9499 | ClinicalTrialsgov_CCAdmin@umich.edu |
| Jul 22, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 25, 2025 | Dec 5, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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