Health TrialsbyHealthPanel

The Comparative Effectiveness Evaluation of the Impact of Digital Education

ConditionPediatric Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

any potential participant who is unable to access messages will also be excluded.

Non cancer pediatric diagnosis

Trial design

Design model

Single group

Treatments tested in this trial

  • text-based education messages only

    Other intervention

    Participants will receive text-based education messages

  • in-clinic tablet-based multimedia education

    Other intervention

    Participants will receive tablet-based multimedia education in clinic

  • standard of care provider led education

    Other intervention

    Participants will receive standard of care education from their provider

Treatment groups

400 Participants
are divided into 4 treatment groups
Group A: text-based education messages onlyActive comparator 1 intervention
Group B: in-clinic tablet-based multimedia education onlyActive comparator 1 intervention
Group C: both text-based and tablet-based digital education strategiesActive comparator 2 interventions
Group D: standard of care provider led educationActive comparator 1 intervention

Trial outcomes

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.

Time frame
6 months

Secondary outcomes

1

Caregiver knowledge

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

Time frame
Baseline, 6 months
2

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)

Time frame
Baseline, 6 months
3

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).

Time frame
Baseline, 6 months
4

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."

Time frame
Baseline, 6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: