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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-01554 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 77618 | Other Identifier | Roswell Park Cancer Institute |
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This trial studies how well a parenting skills intervention works in improving medication adherence in pediatric cancer patients. The parenting skills intervention provides support and skills training to parents who administer medicine daily to their child and may improve the childs taking of medications correctly as prescribed by the doctor. Ultimately, this may improve treatment outcomes, among children who are experiencing an illness.
PRIMARY OBJECTIVES:
I. To pilot test a novel parenting intervention. II. To examine the feasibility and preliminary efficacy of the parenting intervention on child medication adherence among children who are experiencing an illness.
OUTLINE: Participants with poor medication adherence are randomized to 1 of 3 groups.
EARLY GROUP: Participants continue medication adherence monitoring over 1 week and then receive parental skills intervention sessions consisting of 4 integrated components: creating consistent medication routines, education in child management strategies, strategies for helping children adhere to medication, and training in specific parental behavioral techniques over 30 minutes weekly for 4 weeks.
DELAYED GROUP: Participants continue medication adherence monitoring over 2 weeks and then receive parental skills intervention sessions consisting of 4 integrated components: creating consistent medication routines, education in child management strategies, strategies for helping children adhere to medication, and training in specific parental behavioral techniques over 30 minutes weekly for 4 weeks.
LATE GROUP: Participants continue medication adherence monitoring over 3 weeks and then receive parental skills intervention sessions consisting of 4 integrated components: creating consistent medication routines, education in child management strategies, strategies for helping children adhere to medication, and training in specific parental behavioral techniques over 30 minutes weekly for 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delayed Group (delayed parental skills) | Experimental | Participants continue medication adherence monitoring over 2 weeks and then receive parental skills intervention sessions consisting of 4 integrated components: creating consistent medication routines, education in child management strategies, strategies for helping children adhere to medication, and training in specific parental behavioral techniques over 30 minutes weekly for 4 weeks. |
|
| Early Group (early parental skills) | Experimental | Participants continue medication adherence monitoring over 1 week and then receive parental skills intervention sessions consisting of 4 integrated components: creating consistent medication routines, education in child management strategies, strategies for helping children adhere to medication, and training in specific parental behavioral techniques over 30 minutes weekly for 4 weeks. |
|
| Late Group (late parental skills) | Experimental | Participants continue medication adherence monitoring over 3 weeks and then receive parental skills intervention sessions consisting of 4 integrated components: creating consistent medication routines, education in child management strategies, strategies for helping children adhere to medication, and training in specific parental behavioral techniques over 30 minutes weekly for 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Activity | Other | Undergo parenting skills intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective medication adherence | Assessed using Medication Event Monitoring Systems (MEMS) track caps.The project manager will conduct reviews of each child?s medical record to obtain data on the medication dose prescribed each day and dates when the medication was held for illness or toxicity. MEMS-based adherence variables will be constructed as a percentage based upon the ratio of the number of days with MEMS cap openings (X) to the number of days the medication was prescribed (N). Will remove days when the medication was held by the prescriber from the denominator (X/N x 100). | Up to 4 weeks post study |
| Measure | Description | Time Frame |
|---|---|---|
| Change in parenting stress | Pre and post intervention 15minute surveys | Baseline up to 4 weeks post study |
| Intervention feasibility | Assessed using survey assessments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Bouchard | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
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| Patient Monitoring | Procedure | Undergo medication adherence monitoring |
|
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| Questionnaire Administration | Other | Ancillary studies |
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| Up to 4 weeks post study |
| Change in parenting behaviors | Pre and Post intervention 15 minute surveys | Baseline up to 4 weeks |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000098465 | Remote Patient Monitoring |
| ID | Term |
|---|---|
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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