NCT05112458Withdrawn
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 · Last updated 15 Aug 2024
Reason given: Grant funding ended prior to enrolling any participants.
Brief summary (registry, in English)
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).
- Status (registry)
- Withdrawn
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 8 Sept 2021
- Start date
- Jul 2024
- Primary completion date
- Jul 2026
- Lead sponsor
- Indiana University
- Diseases
- Childhood cancers
- NCT number
- NCT05112458
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Age
- Caregiver with a child over age 21
Other
- Non-English speaking (app is in English)
- Caregiver who do not own a smartphone or other internet capable mobile device
Who the study is looking for
- 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
Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.