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OpenTrials
Completed

NCT Number: NCT04480541

A Pilot Study of Roadmap 2.0 in Oncology Caregivers and Patients

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.

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Key information

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The caregiver must have an eligible patient (defined in items 5 - 9, 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). 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.
  • An eligible patient is age ≥5 years.
  • 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.
  • The caregiver and patient must have his/her own smartphone or tablet to participate.

Treatment and study plan

Roadmap 2.0 information system

Behavioral

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

Wearable activity sensor

Other

Caregivers and patients will receive a Fitbit wearable activity sensor

Other names: Fitbit Charge 3

Survey Administration

Other

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

Other names: PROMIS®

Primary outcomes

  1. Roadmap 2.0 login rate

    Time frame: Day 120

    Percentage 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.

  2. Enrollment rate

    Time frame: At time of enrollment

    Percentage of participants (caregivers and patients) enrolled in the study, of the total number approached for enrollment. Qualitative and quantitative analysis will be conducted.

Secondary outcomes

  1. Survey completion rate

    Time frame: Day 120

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

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 21, 2020
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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