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Completed

NCT Number: NCT04094844

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

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).

Completed

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Key information

Age range

5 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Rogel Cancer Center, Ann Arbor, Michigan, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Fitbit Charge 3

Roadmap 2.0 information system

Behavioral

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

Survey Administration

Other

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

Other names: PROMIS®

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.

Primary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Collaborators

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

Registry information

Official study title

A Randomized Trial of Roadmap 2.0

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2019
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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