N/A
N=372
Health Information Technology System ("Roadmap 2.0") in the Context of Hematopoietic Cell Transplantation
Hematologic Diseases
Bottom Line
View on ClinicalTrials.gov: NCT04094844 ↗Enrolled (actual)
372
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Caregiver Health-related Quality of Life (HRQOL) Assessed by the PROMIS Global Health Scale. — 48.18; 48.16 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Wearable activity sensor (Other); Roadmap 2.0 information system (Behavioral); Survey administration (Other); Roadmap 2.0 information system with Positive Activities (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 5+ yrs
- Sex
- All
- Sponsor
- University of Michigan Rogel Cancer Center
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Caregiver Health-related Quality of Life (HRQOL) Assessed by the PROMIS Global Health Scale. |
48.18; 48.16 | — |
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).
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.
Data sourced from ClinicalTrials.gov (NCT04094844). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.