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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    664
  • sponsor
    University of Michigan Rogel Cancer Center
Updated on 25 March 2022
cell transplantation

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).

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).

Details
Condition Hematologic Diseases
Treatment survey administration, Wearable activity sensor, Roadmap 2.0 information system, Roadmap 2.0 information system with Positive Activities
Clinical Study IdentifierNCT04094844
SponsorUniversity of Michigan Rogel Cancer Center
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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