Health Information Technology System ("Roadmap 2.0") in the Context of Hematopoietic Cell Transplantation
- Conditions
- Hematologic Diseases
- Registration Number
- NCT04094844
- Lead Sponsor
- University of Michigan Rogel Cancer Center
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 372
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Caregiver health-related quality of life (HRQOL) assessed by the PROMIS Global Health scale. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
University of Michigan Rogel Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
University of Michigan Rogel Cancer Center🇺🇸Ann Arbor, Michigan, United States