Medication AdherenceNCT05150028
A Virtual Intervention to Improve Medication Adherence in Pediatric Cancer: MedSupport
A study testing Patient participation and Clinician barrier reports in people with Medication Adherence, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
To develop a cancer center level practice intervention to promote treatment adherence and reduce outcome disparities in pediatric cancer survivors Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Medication Adherence
- What is being tested?
- Patient participation and Clinician barrier reports
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2023to 6 Jun 2024
- 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 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parents/caregivers of pediatric patients must meet the following criteria to be eligible:
- Parents/guardians of child that has been diagnosed with any cancer.
- Parents/guardians of child with any cancer between age 0 and 18.
- Parents/guardians of child on home-based oral anti-cancer therapy or supportive care therapy.
- The clinician for the family agrees to participate in the study.
Who cannot join
- Participants will be excluded from this study if unwilling or unable to complete the assessment in English
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
To develop a cancer center level practice intervention to promote treatment adherence and reduce outcome disparities in pediatric cancer survivors
Read the detailed description
To conduct a pilot study to assess the feasibility and acceptability of the Social Determinants of Adherence intervention
- Conditions
- Medication Adherence
- Being tested
- Patient participation, Clinician barrier reports
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient participationBehavioural
Questionnaire
Clinician barrier reportsOther
How many times a 7 question Survey on medication education practices is opened
| Study group | Role | What they receive |
|---|---|---|
| Intervention - Pediatric parent/caregiver | Experimental | Questionnaires along with educational videos Receives: Behavioral: Patient participation |
| Clinicians | Experimental | Will complete pre and post survey about medication education practices Receives: Other: Clinician barrier reports |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention rates
Feasibility of intervention as assessed by retention rates
Measured: Up to 8 weeks
Secondary outcomes (2)
Feasibility of universal SDOA screening
Will be assessed by results of SDOA questionnaire an 8 item questionnaire rated on a 5-point Likert scale (0-I never experienced this ; 5 - I experience this quite a lot)
Measured: up to 8 weeks
Provider satisfaction with barrier reports
REDCap analytics will track the rate of opened barrier reports
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start11 Apr 2023
- Primary completion6 Jun 2023
- Study completion6 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Bouchard, MD, Principal investigator, Roswell Park Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150028
- Sponsor's protocol ID
- I 2048021
- Status last verified
- Sep 2024
- First submitted
- 24 Nov 2021
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Virtual Intervention to Improve Medication Adherence in Pediatric Cancer: MedSupport
- ClinicalTrials.gov ID
- NCT05150028
- Acronym / sponsor ID
- I 2048021
- Conditions
- Medication Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 6 Jun 2024 (actual)
- First posted
- 8 Dec 2021 (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.
To develop a cancer center level practice intervention to promote treatment adherence and reduce outcome disparities in pediatric cancer survivors
Detailed description
To conduct a pilot study to assess the feasibility and acceptability of the Social Determinants of Adherence intervention
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention - Pediatric parent/caregiver | Experimental | Behavioral: Patient participationQuestionnaires along with educational videos |
| Clinicians | Experimental | Other: Clinician barrier reportsWill complete pre and post survey about medication education practices |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Parents/guardians of child that has been diagnosed with any cancer.
- Parents/guardians of child with any cancer between age 0 and 18.
- Parents/guardians of child on home-based oral anti-cancer therapy or supportive care therapy.
- The clinician for the family agrees to participate in the study.
Key exclusion criteria (1 listed)
- Participants will be excluded from this study if unwilling or unable to complete the assessment in English
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 |
|---|---|---|
| Patient participationQuestionnaire | Behavioural | Intervention - Pediatric parent/caregiver |
| Clinician barrier reportsHow many times a 7 question Survey on medication education practices is opened | Other | Clinicians |
Primary outcome
Retention rates
Time frame: Up to 8 weeks
Feasibility of intervention as assessed by retention rates
2 secondary outcomes
Feasibility of universal SDOA screening
Time frame: up to 8 weeks
Provider satisfaction with barrier reports
Time frame: up to 8 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 19 Sep 2024.
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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, MD principal investigator
Roswell Park Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient participation and Clinician barrier reports in people with Medication Adherence, 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 1 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 19 Sep 2024. 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?
Retention rates (time frame: Up to 8 weeks). 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 19 Sep 2024.