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 hematopoietic cell transplantation (HCT).
Full Title of Study: “A Randomized Trial of Roadmap 2.0″
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Supportive Care
- Masking: None (Open Label)
- Study Primary Completion Date: July 2022
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.
- Other: Wearable activity sensor
- Caregivers and patients in both arms of the study will have a Fitbit wearable activity sensor to track activity and sleep.
- Behavioral: Roadmap 2.0 information system
- Caregivers and patients download the Roadmap 2.0 app on their mobile phones
- Other: Survey administration
- Caregivers and patients will be asked to respond to survey questions at 3 timepoints.
- Behavioral: Roadmap 2.0 information system with Positive Activities
- Caregivers and patients download the Roadmap 2.0 app on their mobile phones. Caregivers and patients will be instructed on how to operate Roadmap 1.0 on an iPad (inpatient only) and Roadmap 2.0 on a mobile phone (inpatient and outpatient). Caregivers download the Positive Activities app onto their mobile phone to use freely throughout inpatient and outpatient (through day 120 post-transplant). Caregiver may also use an electronic tablet provided by the study team during the patient’s hospital stay.
Arms, Groups and Cohorts
- Active Comparator: Roadmap 2.0
- Roadmap 2.0 mobile app + wearable sensor to track activity and sleep + usual care (informational or educational resources provided through verbal communication or written hand-out materials).
- Experimental: Roadmap 2.0 with Positive Activities
- Roadmap 2.0 mobile app (patients), Roadmap 2.0 with mobile Positive Activities app (caregivers) + wearable sensor to track activity and sleep + usual care (informational or educational resources provided through verbal communication or written hand-out materials).
Clinical Trial Outcome Measures
- Caregiver health-related quality of life (HRQOL) assessed by the PROMIS Global Health scale.
- Time Frame: 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.
- Caregiver health-related quality of life (HRQOL) assessed by PROMIS Profile 29
- Time Frame: At day 120 post-transplant
- Mean Profile 29 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.
Participating in This Clinical Trial
- 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 the Clinical Practice Guidelines of the U-M BMT Program. 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.
- Patient does not meet eligibility criteria to undergo HCT at the U-M BMT Program.
Gender Eligibility: All
Minimum Age: 5 Years
Maximum Age: 75 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- University of Michigan Rogel Cancer Center
- Department of Health and Human Services
- Provider of Information About this Clinical Study
- Overall Official(s)
- Sung Won Choi, MD, MS, Principal Investigator, University of Michigan Rogel Cancer Center
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