Pediatric CancerNCT06979310
The Comparative Effectiveness Evaluation of the Impact of Digital Education
A study testing text-based education messages only and in-clinic tablet-based multimedia education in people with Pediatric Cancer, run by Duke University.
Trial summary
This study is being conducted to determine how best to educate caregivers about cancer and its treatment. When caregivers are well-informed, they are more confident in supporting their child through treatment, which can improve treatment adherence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- text-based education messages only and in-clinic tablet-based multimedia education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2026to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a known pediatric cancer diagnosis
- Adult caregivers of children with cancer (<18yo) at time of new patient registration
- Ability to understand and speak Swahili
- If illiterate, availability of a household member who can read Swahili
- Be able to access the messages
Who cannot join
- any potential participant who is unable to access messages will also be excluded.
- Non cancer pediatric diagnosis
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Comparative Effectiveness Evaluation of the Impact of Digital Education Via Text Message Versus Multimedia Modules on Caregiver Knowledge
This study is being conducted to determine how best to educate caregivers about cancer and its treatment. When caregivers are well-informed, they are more confident in supporting their child through treatment, which can improve treatment adherence.
- Conditions
- Pediatric Cancer
- Being tested
- text-based education messages only, in-clinic tablet-based multimedia education, standard of care provider led education
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
text-based education messages onlyOther
Participants will receive text-based education messages
in-clinic tablet-based multimedia educationOther
Participants will receive tablet-based multimedia education in clinic
standard of care provider led educationOther
Participants will receive standard of care education from their provider
| Study group | Role | What they receive |
|---|---|---|
| text-based education messages only | Active comparator | Not described Receives: Other: text-based education messages only |
| in-clinic tablet-based multimedia education only | Active comparator | Not described Receives: Other: in-clinic tablet-based multimedia education |
| both text-based and tablet-based digital education strategies | Active comparator | Not described Receives: Other: text-based education messages only; Other: in-clinic tablet-based multimedia education |
| standard of care provider led education | Active comparator | Not described Receives: Other: standard of care provider led education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment abandonment rate.
All analyses estimating efficacy of the intervention will be based on intention-to-treat principles, whereby participants will be analyzed according to their randomization assignment, irrespective of whether they complied with the intervention.
Measured: 6 months
Secondary outcomes (4)
Caregiver knowledge
Caregiver knowledge will be assessed by a 10-question multiple choice survey testing core knowledge on childhood cancer
Measured: Baseline, 6 months
Caregiver attitudes
Caregiver attitudes will be assessed by a version of the Swahili Cataldo Cancer Stigma Scale (CASS) previously modified to target childhood cancer stigma and validated for use in Tanzania by the current study team. Responses are rated using a four-point Likert scale to evaluate the caregivers attitude towards the statements (ranging from 1=strongly disagree; 4=strongly agree)
Measured: Baseline, 6 months
Perceived behavior control
Perceived behavioral control will be assessed using a modified Swahili Generalized Self -Efficacy survey, adapted for use to evaluate caretaker perceived ability to complete therapy as the behavior measured. This is a 12 question item survey with a 5 point Likert scale (1=Not at all confident to 5=Extremely confident).
Measured: Baseline, 6 months
Caregiver intention
Behavior intention will be assessed using a 3-question validated measure of intention translated into Swahili to determine caregiver's intention to complete therapy, with scaled response options from 1 to 7, from "strongly disagree/ very unlikely" to "strongly agree/ very likely."
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start2 Nov 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kristin Schroeder Principal Investigator, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979310
- Sponsor's protocol ID
- Pro00115965
- Other IDs
- 1R21CA284299-01
- Status last verified
- Jul 2026
- First submitted
- 16 May 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All enrolled participants will be assigned a study identification number (ID) to help protect their identity during data collection and analysis. Only study IDs will be used to identify participants' medical record data, survey and interview responses.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparative Effectiveness Evaluation of the Impact of Digital Education Via Text Message Versus Multimedia Modules on Caregiver Knowledge
- ClinicalTrials.gov ID
- NCT06979310
- Acronym / sponsor ID
- Pro00115965
- Conditions
- Pediatric Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 18 May 2025 (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 study is being conducted to determine how best to educate caregivers about cancer and its treatment. When caregivers are well-informed, they are more confident in supporting their child through treatment, which can improve treatment adherence.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| text-based education messages only | Active comparator | Other: text-based education messages only |
| in-clinic tablet-based multimedia education only | Active comparator | Other: in-clinic tablet-based multimedia education |
| both text-based and tablet-based digital education strategies | Active comparator | Other: text-based education messages only, Other: in-clinic tablet-based multimedia education |
| standard of care provider led education | Active comparator | Other: standard of care provider led education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- a known pediatric cancer diagnosis
- Adult caregivers of children with cancer (<18yo) at time of new patient registration
- Ability to understand and speak Swahili
- If illiterate, availability of a household member who can read Swahili
- Be able to access the messages
Key exclusion criteria (2 listed)
- any potential participant who is unable to access messages will also be excluded.
- Non cancer pediatric diagnosis
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 |
|---|---|---|
| text-based education messages onlyParticipants will receive text-based education messages | Other | both text-based and tablet-based digital education strategies, text-based education messages only |
| in-clinic tablet-based multimedia educationParticipants will receive tablet-based multimedia education in clinic | Other | both text-based and tablet-based digital education strategies, in-clinic tablet-based multimedia education only |
| standard of care provider led educationParticipants will receive standard of care education from their provider | Other | standard of care provider led education |
Primary outcome
Treatment abandonment rate.
Time frame: 6 months
All analyses estimating efficacy of the intervention will be based on intention-to-treat principles, whereby participants will be analyzed according to their randomization assignment, irrespective of whether they complied with the intervention.
4 secondary outcomes
Caregiver knowledge
Time frame: Baseline, 6 months
Caregiver attitudes
Time frame: Baseline, 6 months
Perceived behavior control
Time frame: Baseline, 6 months
Caregiver intention
Time frame: Baseline, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No. All enrolled participants will be assigned a study identification number (ID) to help protect their identity during data collection and analysis. Only study IDs will be used to identify participants' medical record data, survey and interview responses.
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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.
Kristin Schroeder Principal Investigator principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A study testing text-based education messages only and in-clinic tablet-based multimedia education in people with Pediatric Cancer, run by Duke University.
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 2 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: opening soon, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hillary Sued Study Coordinator (+255 785 808 594, suedhillary@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment abandonment rate. (time frame: 6 months). 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 14 Oct 2026.