GuardianNCT03895918
Parenting Skills Intervention in Improving Medication Adherence in Pediatric Cancer Patients
A study testing Educational Activity, Patient Monitoring and Questionnaire Administration in people with Guardian and Hematologic and Lymphocytic Disorder, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Guardian, Hematologic and Lymphocytic Disorder, Malignant Neoplasm
- What is being tested?
- Educational Activity, Patient Monitoring and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2019to 25 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be a parent of a child (2 to 10 years old) with any hematology or oncology diagnosis who is receiving treatment at Roswell Park Comprehensive Cancer Center. We define parents as biological parents, adoptive parents, foster parents, stepparents, and legal guardians
- Parent must have primary medication responsibility
- The child's treatment must include home-based daily oral medication
- Parent must have verbal English fluency
- Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Who cannot join
- Be a parent of a pediatric patient with any hematology or oncology diagnosis who is receiving treatment at Roswell Park and is < 2 or > 10 years old
- Parent does not have primary medication responsibility
- Child's treatment does not include home-based daily oral medication
- Parent does not have verbal English fluency
- If unable to consent or a prisoner
- Unwilling or unable to follow protocol requirements
- Any condition which in the investigator?s opinion deems the participant an unsuitable candidate to receive study intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: A Novel Parenting Skills Intervention to Improve Medication Adherence in Pediatric Cancer
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Being tested
- Educational Activity, Patient Monitoring, Questionnaire Administration
- Medical subject headings
- Hematologic Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational ActivityOther
Undergo parenting skills intervention
Patient MonitoringProcedure or surgery
Also called monitor
Undergo medication adherence monitoring
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Educational Activity; Procedure: Patient Monitoring; Other: Questionnaire Administration |
| 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. Receives: Other: Educational Activity; Procedure: Patient Monitoring; Other: Questionnaire Administration |
| 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. Receives: Other: Educational Activity; Procedure: Patient Monitoring; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 4 weeks post study
Secondary outcomes (3)
Change in parenting stress
Pre and post intervention 15minute surveys
Measured: Baseline up to 4 weeks post study
Intervention feasibility
Assessed using survey assessments
Measured: Up to 4 weeks post study
Change in parenting behaviors
Pre and Post intervention 15 minute surveys
Measured: Baseline up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start3 Jan 2019
- Primary completion25 Nov 2020
- Study completion25 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GuardianStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Bouchard, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895918
- Sponsor's protocol ID
- I 77618
- Other IDs
- NCI-2019-01554, I 77618
- Status last verified
- Sep 2021
- First submitted
- 28 Mar 2019
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Parenting Skills Intervention to Improve Medication Adherence in Pediatric Cancer
- ClinicalTrials.gov ID
- NCT03895918
- Acronym / sponsor ID
- I 77618
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 25 Nov 2020 (actual)
- Study completion
- 25 Nov 2020 (actual)
- First posted
- 29 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Delayed Group (delayed parental skills) | Experimental | Other: Educational Activity, Procedure: Patient Monitoring, Other: Questionnaire AdministrationParticipants 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 | Other: Educational Activity, Procedure: Patient Monitoring, Other: Questionnaire AdministrationParticipants 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 | Other: Educational Activity, Procedure: Patient Monitoring, Other: Questionnaire AdministrationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be a parent of a child (2 to 10 years old) with any hematology or oncology diagnosis who is receiving treatment at Roswell Park Comprehensive Cancer Center. We define parents as biological parents, adoptive parents, foster parents, stepparents, and legal guardians
- Parent must have primary medication responsibility
- The child's treatment must include home-based daily oral medication
- Parent must have verbal English fluency
- Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Key exclusion criteria (7 listed)
- Be a parent of a pediatric patient with any hematology or oncology diagnosis who is receiving treatment at Roswell Park and is < 2 or > 10 years old
- Parent does not have primary medication responsibility
- Child's treatment does not include home-based daily oral medication
- Parent does not have verbal English fluency
- If unable to consent or a prisoner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational ActivityUndergo parenting skills intervention | Other | Delayed Group (delayed parental skills), Early Group (early parental skills), Late Group (late parental skills) |
| Patient MonitoringAlso: monitorUndergo medication adherence monitoring | Procedure or surgery | Delayed Group (delayed parental skills), Early Group (early parental skills), Late Group (late parental skills) |
| Questionnaire AdministrationAncillary studies | Other | Delayed Group (delayed parental skills), Early Group (early parental skills), Late Group (late parental skills) |
Primary outcome
Objective medication adherence
Time frame: Up to 4 weeks post study
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).
3 secondary outcomes
Change in parenting stress
Time frame: Baseline up to 4 weeks post study
Intervention feasibility
Time frame: Up to 4 weeks post study
Change in parenting behaviors
Time frame: Baseline up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Bouchard principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Activity, Patient Monitoring and Questionnaire Administration in people with Guardian and Hematologic and Lymphocytic Disorder, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective medication adherence (time frame: Up to 4 weeks post study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.