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Hematologic DiseasesNCT04094844

Health Information Technology System ("Roadmap 2.0") in the Context of Hematopoietic Cell Transplantation

A study testing Wearable activity sensor, Roadmap 2.0 information system and Survey administration in people with Hematologic Diseases, run by University of Michigan Rogel Cancer Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 5 to 75 years
Conditions the study is for
Hematologic Diseases
What is being tested?
Wearable activity sensor, Roadmap 2.0 information system and Survey administration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
372 participants
Where
2 sitesUnited States
Study dates
8 Sep 2020to 11 Aug 2024
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 5 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • The caregiver must have an eligible patient (see below)
  • The caregiver must be of age ≥18 years.
  • The caregiver should be comfortable in reading and speaking English and signing informed consents.
  • The caregiver should provide at least 50% of care needs.
  • An eligible patient is one who identifies the eligible caregiver as their primary caregiver (i.e., provides at least 50% of care needs).
  • An eligible patient is age ≥5 years.
Show all 10Show fewer
  • An eligible patient is scheduled to undergo HCT.
  • An eligible patient is able to sign informed consent/assent forms.
  • Patients and caregivers agree to provide informed consent that is in regulatory compliance and IRBMED-approved and also in accordance to institutional guidelines. A patient is able to undergo HCT at the U-M only if a designated family caregiver (e.g., parents, adult children, spouses, family members, neighbors, friends) accepts the roles, in accordance to the Clinical Practice Guidelines of the U-M BMT Program.
  • The caregiver and patient must have his/her own smartphone to participate.

Who cannot join

  • Patient does not meet eligibility criteria to undergo HCT at the U-M BMT Program or Oregon Health \& Sciences University.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

  • Oregon Health & Science University

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: A Randomized Trial of Roadmap 2.0

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).

Read the detailed description

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).

Being tested
Wearable activity sensor, Roadmap 2.0 information system, Survey administration, Roadmap 2.0 information system with Positive Activities
Keywords
Hematopoietic Cell Transplantation, Mobile Health Technology
Medical subject headings
Hematologic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wearable activity sensorOther

    Also called Fitbit Charge 3

    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 systemBehavioural

    Caregivers and patients download the Roadmap 2.0 app on their mobile phones or tablets

  • Survey administrationOther

    Also called PROMIS®

    Caregivers and patients will be asked to respond to survey questions at 3 timepoints.

  • Roadmap 2.0 information system with Positive ActivitiesBehavioural

    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.

Study groups in NCT04094844
Study groupRoleWhat they receive
Roadmap 2.0Active comparatorRoadmap 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
Receives: Other: Wearable activity sensor; Behavioral: Roadmap 2.0 information system; Other: Survey administration
Roadmap 2.0 with Positive ActivitiesExperimentalRoadmap 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
Receives: Other: Wearable activity sensor; Other: Survey administration; Behavioral: Roadmap 2.0 information system with Positive Activities

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At day 120 post-transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2019
  2. Study start8 Sep 2020
  3. Primary completion11 Aug 2024
  4. Study completion11 Aug 2024

Resources

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
Randomised
Intervention model
Parallel groups
Model description
* Active comparator arm: Adult caregivers (n=166) with adult patients \>/= 18 years of age (n=83) and pediatric patient \<18 years of age (n=83) * Experimental arm: Adult caregivers (n=166) with adult patients \>/= 18 years of age (n=83) and pediatric patient \<18 years of age (n=83)
Masking
None (open label)
Enrolment
372 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04094844
Sponsor's protocol ID
UMCC 2019.106
Other IDs
HUM00165192, HUM00186436, R01HL146354
Status last verified
Apr 2026
First submitted
16 Sep 2019
Last updated
14 Apr 2026
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40822733

  • 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.

    PubMed 37651172

  • 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.

    PubMed 32945777

Questions about this trial

What is this clinical trial studying?

A study testing Wearable activity sensor, Roadmap 2.0 information system and Survey administration in people with Hematologic Diseases, run by University of Michigan Rogel Cancer Center at 2 sites 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 10 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 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 14 Apr 2026). 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?

Caregiver Health-related Quality of Life (HRQOL) Assessed by the PROMIS Global Health Scale. (time frame: At day 120 post-transplant). 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 NCT04094844, which also lists 3 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 14 Apr 2026.

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