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

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

A Randomized Trial of Roadmap 2.0

NCT04094844•University of Michigan Rogel Cancer Center

View on ClinicalTrials.gov

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).

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).

Eligibility

Age

5 - 75 years

Sex

ALL

Healthy Volunteers

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.

Locations (2)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Oregon Health & Science University

Portland, Oregon, United States

Key Dates

Start Date

September 8, 2020

Primary Completion Date

August 11, 2024

Completion Date

August 11, 2024

Last Updated

January 14, 2025

Enrollment

372

ACTUAL participants

Conditions

Hematologic Diseases

Interventions

Wearable activity sensor

OTHER

Roadmap 2.0 information system

BEHAVIORAL

Survey administration

OTHER

Roadmap 2.0 information system with Positive Activities

BEHAVIORAL

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RECRUITING

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Hematologic Diseases

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

The Implementation of the Go Wish Game to Promote Advance Care Planning in Onco- Hematologic Disease

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