Clinical trial NCT04094844: Health Information Technology System ("Roadmap 2.0") in the Context of Hematopoietic Cell Transplantation
Official title: A Randomized Trial of Roadmap 2.0
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematologic Diseases
Keywords: Hematopoietic Cell Transplantation
Mobile Health Technology
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-09-19
Enrollment: 372
Sex: ALL
Minimum age (years): 5
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * 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)
Primary purpose: SUPPORTIVE_CARE

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).

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 criteria: 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.

Primary outcomes:
measure: Caregiver health-related quality of life (HRQOL) assessed by the PROMIS Global Health scale.
timeFrame: At day 120 post-transplant
Secondary outcomes:
Other outcomes:
measure: Caregiver health-related quality of life (HRQOL) assessed by PROMIS Profile 29+2 (exploratory)
timeFrame: At day 120 post-transplant
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Sung Won Choi, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.