Clinical trial · Interventional
A Pilot Study of Roadmap 2.0 in Oncology Caregivers and Patients
NCT04480541CI-TRIAL-00071784completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Roadmap 2.0 information system | Behavioral | — | UNRESOLVED |
| Survey administration | Other | — | UNRESOLVED |
| Wearable activity sensor | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Roadmap 2.0 + Fitbit Charge 3
- description
- * 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.
- interventionNames
- Behavioral: Roadmap 2.0 information system
- Other: Wearable activity sensor
- Other: Survey administration
Primary outcomes (2)
- measure
- Roadmap 2.0 login rate
- timeFrame
- Day 120
- description
- 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.
- measure
- Enrollment rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.