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A Pilot Study of Roadmap 2.0 in Oncology Caregivers and Patients

A Pilot Study of Roadmap 2.0 in Oncology Caregivers and Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04480541
Enrollment
138
Registered
2020-07-21
Start date
2020-09-18
Completion date
2023-06-20
Last updated
2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Quality of Life

Keywords

Mobile Health Technology

Brief summary

This study will investigate the use of a mobile health app (Roadmap 2.0) intervention in caregivers of patients with cancer. In this study participants will be given the Roadmap 2.0 app, with a focus on the positive aspects of caregiving (positive activity components), and a Fitbit. The primary objective of this pilot study is to test the feasibility and acceptability of using the mobile health app.

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).

Interventions

Caregivers and patients download the Roadmap 2.0 app on their own mobile phones/tablet

Caregivers and patients will receive a Fitbit wearable activity sensor

OTHERSurvey administration

Caregivers and patients will be asked to complete health-related quality of life surveys

Sponsors

University of Michigan Rogel Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. The caregiver must have an eligible patient (defined in items 5 - 9, below) 2. The caregiver must be of age ≥18 years. 3. The caregiver should be comfortable in reading and speaking English and signing informed consents. 4. The caregiver should provide at least 50% of care needs. 5. An eligible patient is one who identifies the eligible caregiver as their primary caregiver (i.e., provides at least 50% of care needs). The caregiver who provides consent will be deemed the caregiver who participates in the study. In adolescents who are at the age to provide assent, she/he will designate the caregiver who provides \>50% of their care, and that caregiver will sign the consent document. 6. An eligible patient is age ≥5 years. 7. An eligible patient is able to sign informed consent/assent forms. 8. Patients and caregivers agree to provide informed consent that is in regulatory compliance and IRBMED-approved. 9. The caregiver and patient must have his/her own smartphone or tablet to participate.

Design outcomes

Primary

MeasureTime frameDescription
Roadmap 2.0 login rateDay 120Percentage of participants (caregivers and patients) who login to Roadmap 2.0 at least 2 times per week for at least 50% of the study duration (120 days). Login data will be collected by the Roadmap 2.0 software. Qualitative and quantitative analysis will be conducted.
Enrollment rateAt time of enrollmentPercentage of participants (caregivers and patients) enrolled in the study, of the total number approached for enrollment. Qualitative and quantitative analysis will be conducted.

Secondary

MeasureTime frameDescription
Survey completion rateDay 120Percentage of participants (caregivers and patients) who complete all 3 surveys at each of 3 designated time points: Day 0, day 30 and day 120.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026