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

NCT04094844 | Completed Results

• 4 other identifiers: UMCC 2019.106HUM00165192HUM00186436R01HL146354
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Hematologic Diseases

Keywords

Hematopoietic Cell Transplantation; Mobile Health Technology

Outcome Measures

Primary Outcomes (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.

  At day 120 post-transplant

Other Outcomes (1)

• Caregiver Health-related Quality of Life (HRQOL) Assessed by PROMIS Profile 29+2 (Exploratory)

  At day 120 post-transplant

Study Arms (2)

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

Other: Wearable activity sensor; Behavioral: Roadmap 2.0 information system; Other: Survey administration

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

Other: Wearable activity sensor; Other: Survey administration; Behavioral: Roadmap 2.0 information system with Positive Activities

Interventions

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.

Also known as: Fitbit Charge 3

Roadmap 2.0; Roadmap 2.0 with Positive Activities

Roadmap 2.0 information system BEHAVIORAL

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

Roadmap 2.0

Survey administration OTHER

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

Also known as: PROMIS®

Roadmap 2.0; Roadmap 2.0 with Positive Activities

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.

Roadmap 2.0 with Positive Activities

Eligibility Criteria

• Age: 5 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• Department of Health and Human Services: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (3)

• 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.

  PMID: 40822733 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.

  PMID: 37651172 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.

  PMID: 32945777 DERIVED

MeSH Terms

Conditions

Hematologic Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Results Point of Contact

• Title: University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin
• Organization: University of Michigan Rogel Cancer Center

ClinicalTrialsgov_CCAdmin@umich.edu

734-936-9499

Study Officials

• Sung Won Choi, MD, MS

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * 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)

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 19, 2019
• Study Start: September 8, 2020
• Primary Completion: August 11, 2024
• Study Completion: August 11, 2024
• Last Updated: April 14, 2026
• Results First Posted: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)