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A Pilot Study of Roadmap 2.0 in Oncology Caregivers and Patients

NCT ID: NCT04480541

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-18

Study Completion Date

2023-06-20

Brief Summary

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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

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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).

Conditions

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Cancer Quality of Life

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Roadmap 2.0 + Fitbit Charge 3

* 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.

Group Type EXPERIMENTAL

Roadmap 2.0 information system

Intervention Type BEHAVIORAL

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

Wearable activity sensor

Intervention Type OTHER

Caregivers and patients will receive a Fitbit wearable activity sensor

Survey administration

Intervention Type OTHER

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

Interventions

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Roadmap 2.0 information system

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

Intervention Type BEHAVIORAL

Wearable activity sensor

Caregivers and patients will receive a Fitbit wearable activity sensor

Intervention Type OTHER

Survey administration

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

Intervention Type OTHER

Other Intervention Names

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Fitbit Charge 3 PROMIS®

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan Rogel Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sung Won Choi, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

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University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00176584

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2020.040

Identifier Type: -

Identifier Source: org_study_id