NCT04480541

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 18, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

2.8 years

First QC Date

July 16, 2020

Last Update Submit

November 28, 2023

Conditions

CancerQuality of Life

Keywords

Mobile Health Technology

Outcome Measures

Primary Outcomes (2)

  • Roadmap 2.0 login rate

    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.

    Day 120

  • Enrollment rate

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

    At time of enrollment

Secondary Outcomes (1)

  • Survey completion rate

    Day 120

Study Arms (1)

Roadmap 2.0 + Fitbit Charge 3

EXPERIMENTAL

* 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.

Behavioral: Roadmap 2.0 information systemOther: Wearable activity sensorOther: Survey administration

Interventions

Roadmap 2.0 information systemBEHAVIORAL

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

Roadmap 2.0 + Fitbit Charge 3
Wearable activity sensorOTHER

Caregivers and patients will receive a Fitbit wearable activity sensor

Also known as: Fitbit Charge 3
Roadmap 2.0 + Fitbit Charge 3
Survey administrationOTHER

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

Also known as: PROMIS®
Roadmap 2.0 + Fitbit Charge 3

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Sung Won Choi, MD, MS

    University of Michigan Rogel Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2020

First Posted

July 21, 2020

Study Start

September 18, 2020

Primary Completion

June 20, 2023

Study Completion

June 20, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)