An mHealth Intervention to Improve Guardians’ Adherence to Children’s Follow-Up Care for Acute Lymphoblastic Leukemia in Tanzania (GuardiansCan Project): Protocol for a Development and Feasibility Study

Abstract

Background Cancer is a leading cause of death during childhood and in low- and middle-income countries survival rates can be as low as 20%. A leading reason for low childhood cancer survival rates in low- and middle-income countries such as Tanzania is treatment abandonment. Contributing factors include poor communication between health care providers and children’s guardians, insufficient cancer knowledge, and psychological distress. Objective Our aim is to respond to Tanzanian guardians’ poor adherence to children’s follow-up care after treatment for acute lymphoblastic leukemia with the help of mobile health (mHealth) technology. Our goal is to increase guardians’ adherence to children’s medications and follow-up visits and to decrease their psychological distress. Methods Following the Medical Research Council framework for developing and evaluating complex interventions, we will undertake the GuardiansCan project in an iterative phased approach to develop an mHealth intervention for subsequent testing. Public contribution activities will be implemented throughout via the establishment of a Guardians Advisory Board consisting of guardians of children with acute lymphoblastic leukemia. We will examine the acceptability, feasibility, and perceived impact of Guardians Advisory Board activities via an impact log and semistructured interviews (study I). In phase 1 (intervention development) we will explore guardians’ needs and preferences for the provision of follow-up care reminders, information, and emotional support using focus group discussions and photovoice (study II). We will then co-design the mHealth intervention with guardians, health care professionals, and technology experts using participatory action research (study III). In phase 2 (feasibility), we will examine clinical, methodological, and procedural uncertainties associated with the intervention and study procedures to prepare for the design and conduct of a future definitive randomized controlled trial using a single-arm pre-post mixed methods feasibility study (study IV). Results Data collection for the GuardiansCan project is anticipated to take 3 years. We plan to commence study I by recruiting Guardians Advisory Board members in the autumn of 2023. Conclusions By systematically following the intervention development and feasibility phases of the Medical Research Council Framework, and working alongside an advisory board of guardians, we intend to develop an acceptable, culturally appropriate, feasible, and relevant mHealth intervention with the potential to increase guardians’ adherence to children’s follow-up care after treatment of acute lymphoblastic leukemia, leading to a positive impact on children’s health and chances to survive, and reducing distress for guardians. International Registered Report Identifier (IRRID) PRR1-10.2196/48799

Examining the involvement of guardians of children with acute lymphoblastic leukemia in Tanzania as public contributors to inform the design and conduct of the GuardiansCan project: A mixed‐methods study protocol

“…Overall objectives for Study I, II, III, and IV of the project can be seen in Figure 1 and a detailed overview has been published. 13 …”

“…Therefore, we are currently undertaking the GuardiansCan project, aiming to respond to Tanzanian guardians' poor adherence to children's follow‐up care after treatment for acute lymphoblastic leukemia (ALL) with the help of mHealth technology. 13 ALL is targeted due to potential challenges adhering to treatment and follow‐up care during the long‐term maintenance period (2–3 years), given treatment length and complexity are associated with nonadherence. 14 …”