CancerNCT04480541
A Pilot Study of Roadmap 2.0 in Oncology Caregivers and Patients
A study testing Roadmap 2.0 information system, Wearable activity sensor and Survey administration in people with Cancer and Quality of Life, run by University of Michigan Rogel Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Cancer, Quality of Life
- What is being tested?
- Roadmap 2.0 information system, Wearable activity sensor and Survey administration
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2020to 20 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
About this study
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.
Read the detailed 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).
- Conditions
- Cancer, Quality of Life
- Being tested
- Roadmap 2.0 information system, Wearable activity sensor, Survey administration
- Keywords
- Mobile Health Technology
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roadmap 2.0 information systemBehavioural
Caregivers and patients download the Roadmap 2.0 app on their own mobile phones/tablet
Wearable activity sensorOther
Also called Fitbit Charge 3
Caregivers and patients will receive a Fitbit wearable activity sensor
Survey administrationOther
Also called PROMIS®
Caregivers and patients will be asked to complete health-related quality of life surveys
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Roadmap 2.0 information system; Other: Wearable activity sensor; Other: Survey administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At time of enrollment
Secondary outcomes (1)
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.
Measured: Day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start18 Sep 2020
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sung Won Choi, MD, MS, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480541
- Sponsor's protocol ID
- UMCC 2020.040
- Other IDs
- HUM00176584
- Status last verified
- Nov 2023
- First submitted
- 16 Jul 2020
- Last updated
- 29 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Roadmap 2.0 in Oncology Caregivers and Patients
- ClinicalTrials.gov ID
- NCT04480541
- Acronym / sponsor ID
- UMCC 2020.040
- Conditions
- Cancer, Quality of Life
- Keywords
- Mobile Health Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Roadmap 2.0 + Fitbit Charge 3 | Experimental | Behavioral: Roadmap 2.0 information system, Other: Wearable activity sensor, Other: Survey administration* 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. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roadmap 2.0 information systemCaregivers and patients download the Roadmap 2.0 app on their own mobile phones/tablet | Behavioural | Roadmap 2.0 + Fitbit Charge 3 |
| Wearable activity sensorAlso: Fitbit Charge 3Caregivers and patients will receive a Fitbit wearable activity sensor | Other | Roadmap 2.0 + Fitbit Charge 3 |
| Survey administrationAlso: PROMIS®Caregivers and patients will be asked to complete health-related quality of life surveys | Other | Roadmap 2.0 + Fitbit Charge 3 |
Primary outcome
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.
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.
1 secondary outcome
Survey completion rate
Time frame: Day 120
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung Won Choi, MD, MS principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Roadmap 2.0 information system, Wearable activity sensor and Survey administration in people with Cancer and Quality of Life, run by University of Michigan Rogel Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Roadmap 2.0 login rate (time frame: Day 120). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.