A Pilot Study of Roadmap 2.0 in Oncology Caregivers and Patients

Cancer Clinical Trial

Official title:

A Pilot Study of Roadmap 2.0 in Oncology Caregivers and Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04480541
• Other study ID #: UMCC 2020.040
• Secondary ID: HUM00176584
• Status: Completed
• Phase: N/A
• Start date: September 18, 2020
• Est. completion date: June 20, 2023

Study information

• Verified date: November 2023
• Source: University of Michigan Rogel Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: June 20, 2023
• Est. primary completion date: June 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Quality of Life

Intervention

Behavioral:
• Roadmap 2.0 information system
Caregivers and patients download the Roadmap 2.0 app on their own mobile phones/tablet

Other:
• Wearable activity sensor
Caregivers and patients will receive a Fitbit wearable activity sensor
• Survey administration
Caregivers and patients will be asked to complete health-related quality of life surveys

Locations

Country	Name	City	State
United States	University of Michigan Rogel Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Survey completion rate	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.	Day 120