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

April 10, 2026 updated by: University of Michigan Rogel Cancer Center

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

372

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Rogel Cancer Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 71 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • 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.
  • 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.

Exclusion Criteria

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Roadmap 2.0

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
Other: Wearable activity sensor
Caregivers and patients in both arms of the study will have a Fitbit wearable activity sensor to track activity and sleep.
Other Names:
  • Fitbit Charge 3
Behavioral: Roadmap 2.0 information system
Caregivers and patients download the Roadmap 2.0 app on their mobile phones or tablets
Other: Survey administration
Caregivers and patients will be asked to respond to survey questions at 3 timepoints.
Other Names:
  • PROMIS®
Experimental: Roadmap 2.0 with Positive Activities

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
Other: Wearable activity sensor
Caregivers and patients in both arms of the study will have a Fitbit wearable activity sensor to track activity and sleep.
Other Names:
  • Fitbit Charge 3
Other: Survey administration
Caregivers and patients will be asked to respond to survey questions at 3 timepoints.
Other Names:
  • PROMIS®
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver Health-related Quality of Life (HRQOL) Assessed by the PROMIS Global Health Scale.
Time Frame: At day 120 post-transplant
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver Health-related Quality of Life (HRQOL) Assessed by PROMIS Profile 29+2 (Exploratory)
Time Frame: At day 120 post-transplant
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan Rogel Cancer Center

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
Department of Health and Human Services

Investigators

  • Principal Investigator: Sung Won Choi, MD, MS, University of Michigan Rogel Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2020

Primary Completion (Actual)

August 11, 2024

Study Completion (Actual)

August 11, 2024

Study Registration Dates

First Submitted

September 16, 2019

First Submitted That Met QC Criteria

September 16, 2019

First Posted (Actual)

September 19, 2019

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMCC 2019.106
  • HUM00165192 (Other Identifier: University of Michigan)
  • HUM00186436 (Other Identifier: University of Michigan)
  • R01HL146354 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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