The Comparative Effectiveness Evaluation of the Impact of Digital Education

NCT06979310 | Not Yet Recruiting

• 2 other identifiers: Pro001159651R21CA284299-01
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pediatric Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (4)

• Caregiver knowledge

  Baseline, 6 months

• Caregiver attitudes

  Baseline, 6 months

• Perceived behavior control

  Baseline, 6 months

• Caregiver intention

  Baseline, 6 months

Study Arms (4)

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

Interventions

in-clinic tablet-based multimedia education OTHER

Participants will receive tablet-based multimedia education in clinic

both text-based and tablet-based digital education strategies; in-clinic tablet-based multimedia education only

standard of care provider led education OTHER

Participants will receive standard of care education from their provider

standard of care provider led education

text-based education messages only OTHER

Participants will receive text-based education messages

both text-based and tablet-based digital education strategies; text-based education messages only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• any potential participant who is unable to access messages will also be excluded.
• Non cancer pediatric diagnosis

Sponsors & Collaborators

• Duke University: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Neoplasms

Study Officials

• Kristin Schroeder Principal Investigator

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hillary Sued Study Coordinator

CONTACT

+255 785 808 594; suedhillary@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 18, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share