Ignite Creation Date:
2024-05-06 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 2:17 PM
Study NCT ID:
NCT05112458
Status:
WITHDRAWN
Last Update Posted:
2024-05-21
First Post:
2021-09-08
Brief Title:
Cope 360 App for Caregivers of Children With Cancer
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Pilot Randomized Control Trial of Cope 360 App for Caregivers of Children With Cancer
Status:
WITHDRAWN
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Grant funding ended prior to enrolling any participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 skillsknowledge 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 skillsknowledge and caregiver stress and 4 effect on healthcare utilization of the child with cancer ie preliminary data about sick visits and ED encounters
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 skillsknowledge and caregiver stress and 4 effect on healthcare utilization of the child with cancer ie 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 investigators 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 participants child
Randomization Caregivers will be randomized into either the intervention group or the usual care group Randomization tables will be generated with SAS v94 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 experienceexposureawareness with computer or health technology Information gathered will also include basic information about their childs 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 v94 Qualtrics and Microsoft Excel
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 participants child
Randomization Caregivers will be randomized into either the intervention group or the usual care group Randomization tables will be generated with SAS v94 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 experienceexposureawareness with computer or health technology Information gathered will also include basic information about their childs 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 v94 Qualtrics and Microsoft Excel
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5K08CA230218-04 | NIH | None | httpsreporternihgovquickSearch5K08CA230218-04 |