The Comparative Effectiveness Evaluation of the Impact of Digital Education

N/ANot Yet RecruitingNCT06979310

Duke University400 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

400

Conditions

Pediatric Cancer

Interventions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

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

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

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

Central Contacts

Hillary Sued Study Coordinator

CONTACT

+255 785 808 594 suedhillary@gmail.com

Data from ClinicalTrials.gov

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