A Pilot Study of Roadmap 2.0 in Oncology Caregivers and Patients

University of Michigan Rogel Cancer Center

Status: Completed

Conditions: Quality of Life; Cancer

Treatments: Other: Wearable activity sensor; Other: Survey administration; Behavioral: Roadmap 2.0 information system

Study type: Interventional

Funder types: Other

Identifiers

NCT04480541

HUM00176584 (Other Identifier)

UMCC 2020.040

Details and patient eligibility

About

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.

Full 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).

Enrollment: 138 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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138 participants in 1 patient group

Roadmap 2.0 + Fitbit Charge 3

Experimental group

Description:

* Caregivers and patients download the Roadmap 2.0 mobile app on their own mobile phones or tablet to use freely throughout the 120 day study period. * Caregivers and patients receive a Fitbit wearable activitiy sensor to track activity and sleep.

Treatment:

Behavioral: Roadmap 2.0 information system

Other: Survey administration

Other: Wearable activity sensor