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

University of Michigan Rogel Cancer Center372 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

372

Conditions

Hematologic Diseases

Interventions

Wearable activity sensorOTHER

Caregivers and patients in both arms of the study will have a Fitbit wearable activity sensor to track activity and sleep.

Roadmap 2.0 information systemBEHAVIORAL

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

Survey administrationOTHER

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

Eligibility

Sex: ALLMin age: 5 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: At day 120 post-transplant

Data from ClinicalTrials.gov

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