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NCT Number: NCT06979310

The Comparative Effectiveness Evaluation of the Impact of Digital Education

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

text-based education messages only

Other

Participants will receive text-based education messages

in-clinic tablet-based multimedia education

Other

Participants will receive tablet-based multimedia education in clinic

standard of care provider led education

Other

Participants will receive standard of care education from their provider

Primary outcomes

  1. 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.

Secondary outcomes

  1. Caregiver knowledge

    Time frame: Baseline, 6 months

    Caregiver knowledge will be assessed by a 10-question multiple choice survey testing core knowledge on childhood cancer

  2. Caregiver attitudes

    Time frame: Baseline, 6 months

    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)

  3. Perceived behavior control

    Time frame: Baseline, 6 months

    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).

  4. Caregiver intention

    Time frame: Baseline, 6 months

    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."

Study contacts

Contact information is provided by the study sponsor or research team.

Hillary Sued Study Coordinator

CONTACT

[email protected]

+255 785 808 594

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

The Comparative Effectiveness Evaluation of the Impact of Digital Education Via Text Message Versus Multimedia Modules on Caregiver Knowledge

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 18, 2025
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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