Clinical trial NCT05112458: Cope 360 App for Caregivers of Children With Cancer
Official title: Pilot Randomized Control Trial of Cope 360 App for Caregivers of Children With Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pediatric Cancer
Keywords: mobile health
supportive care
adolescent
child
oncology
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-11-08
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Half of the participants will receive the intervention and half will receive standard care. All will be assessed at enrollment, 1 month, 3 month, and 6 month time points.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).

Detailed description: Procedure: The investigators will identify approximately 164 primary caregivers of children with cancer, 82 for both the intervention group and the usual care group. Those in the intervention group will be presented with the mHealth app and with the help of the RA, the participants will download the app onto their personal smartphone. Participants will be asked to use the app for a 6-month period of time. They will also receive standardized education that is provided to all caregivers of newly diagnosed patients at the investigator's institution. Those in the usual care group will receive standardized education. These caregivers will NOT be provided with access to the app.

After a participant has been enrolled in the study, the RA will collect demographic and contact information and will administer baseline assessments. Follow-up surveys with a unique identifier will be administered via email at 1, 3 and 6 months for caregivers in both the intervention and control groups. If a survey is not completed, the RA will attempt to contact the participant by phone. Surveys will be administered via Qualtrics. The investigators will collect data via these surveys on participant demographics and mobile technology usage, and outcomes will be measured utilizing the following assessments: the Caregiver Self-Efficacy scale, Caregiver Mastery scale, Pediatric Inventory for Parents, and the Technology Acceptance Model. Semi-structured interviews will be done with a subset of participants in the intervention group at the 6-month mark. Intervention participants will be contacted by phone or email and asked to participate in the interview until a subset of 30 is reached. Interviews will be conducted in person, by phone, or by Zoom videoconferencing depending on the clinic schedule of the participant's child.

Randomization: Caregivers will be randomized into either the intervention group or the usual care group. Randomization tables will be generated with SAS v9.4 utilizing the PROC PLAN procedure.

Data Collection and Analysis: Data will be collected on a variety of socio-demographic factors that have been hypothesized to impact acceptability and use of technology: age, education, gender, race, income, prior experience/exposure/awareness with computer or health technology. Information gathered will also include basic information about their child's cancer diagnosis including: type of cancer, date of diagnosis, and type of treatment protocol. Semi-structured interviews will transcribed and analyzed using Nvivo qualitative research software. Survey data will be analyzed with SAS v9.4, Qualtrics, and Microsoft Excel.

Eligibility criteria: 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

Primary outcomes:
measure: Technology Feasibility Scale Rating
timeFrame: 6 months
measure: Qualitative Technology Feasibility
timeFrame: 6 months
measure: Data Log User Acceptability
timeFrame: 6 months
measure: Self-Efficacy Scale Rating
timeFrame: 6 months
measure: Mastery of Caregiving Scale Rating
timeFrame: 6 months
measure: Stress Reduction Scale Rating
timeFrame: 6 months
measure: Healthcare Utilization Effect
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Indiana University
name: Emily L Mueller, MD
role: PRINCIPAL_INVESTIGATOR
References: