Clinical trial · Interventional
Cope 360 App for Caregivers of Children With Cancer
Pilot Randomized Control Trial of Cope 360 App for Caregivers of Children With Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Grant funding ended prior to enrolling any participants.
Summary
Brief summary (as posted)
To date, most caregiver focused interventions have been targeted at caregivers of adults with cancer, completely ignoring the unique needs of caregivers of children with cancer. A recent meta-analysis indicated that although these interventions had small to medium effects, they significantly reduced burden, improved ability to cope, increased self-efficacy, and improved aspects of caregivers' quality of life. Yet, several recent reviews highlighted a lack of interventions to provide practical skills for the day-to-day provision of care. The investigators have developed a pediatric oncology caregiver-focused intervention that seeks to improve caregiver clinical skills/knowledge, self-efficacy, and support seeking skills. Cope 360 is a mHealth (mobile health) app designed to support caregivers of children with cancer with symptom tracking, medication management, and emergency preparedness. The investigators propose to evaluate Cope 360 via a pilot, randomized control trial in which some caregivers will receive the app and some will not. The purpose of this study is to assess: 1) feasibility of caregiver use over extended period of time, 2) acceptability of the mHealth tool by caregivers in a real-world setting, 3) impact of the mHealth tool on caregiver self-efficacy, mastery of caregiving skills/knowledge, and caregiver stress, and 4) effect on healthcare utilization of the child with cancer (i.e. preliminary data about sick visits and ED encounters).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cope 360 mobile health application | Other | — | UNRESOLVED |
| Usual care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cope 360 application
- description
- Participants are given access to the application and will use it to care for their child with cancer for a period of 6 months.
- interventionNames
- Other: Cope 360 mobile health application
- type
- ACTIVE_COMPARATOR
- label
- Usual Care
- description
- Participants are given usual care and not given access to the application. They will be surveyed along with the experimental group for a period of 6 months.
- interventionNames
- Other: Usual care
Primary outcomes (7)
- measure
- Technology Feasibility Scale Rating
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * English-speaking (app is in English) * Caregiver (parent, legal guardian, grandparent, etc.) to a child with cancer * Caregiver to a child with cancer currently undergoing therapy (chemotherapy, radiation, etc.) * Caregiver to a child with cancer who anticipates therapy to continue for 6 months after recruitment * Caregiver to a child with cancer between the ages of 0 and 21 years old * Must own a smartphone or other internet capable mobile device Exclusion Criteria: * Non-English speaking (app is in English) * Caregiver with a child with cancer who is not currently undergoing therapy * Caregiver to a child with cancer who does not anticipate therapy to continue for 6 months after recruitment * Caregiver with a child over age 21 * Caregiver who do not own a smartphone or other internet capable mobile device
References
Publications (0)
Data not yet available