Hematologic Diseases
Conditions
Keywords
Hematopoietic Cell Transplantation, Mobile Health Technology
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).
Interventions
Caregivers and patients in both arms of the study will have a Fitbit wearable activity sensor to track activity and sleep.
BEHAVIORALRoadmap 2.0 information system
Caregivers and patients download the Roadmap 2.0 app on their mobile phones or tablets
OTHERSurvey administration
Caregivers and patients will be asked to respond to survey questions at 3 timepoints.
BEHAVIORALRoadmap 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.
Sponsors
University of Michigan Rogel Cancer Center
Department of Health and Human Services
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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)
Eligibility
Sex/Gender
ALL
Age
5 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. Scores generally range from 20 to 80, with higher scores indicating better health. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSung Won Choi, MD, MS
University of Michigan Rogel Cancer Center
Participant flow
Recruitment details
Caregiver- Patient dyads were enrolled and reported as individual participants
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized | 51.6 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 355 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 310 Participants |
| Region of Enrollment United States | 91 participants |
| Sex: Female, Male Female | 208 Participants |
| Sex: Female, Male Male | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 95 | 2 / 95 | 3 / 91 | 3 / 91 |
| other Total, other adverse events | 0 / 95 | 0 / 95 | 0 / 91 | 0 / 91 |
| serious Total, serious adverse events | 0 / 95 | 0 / 95 | 0 / 91 | 0 / 91 |
Outcome results
None listed