Challenges and adaptations for a cluster-randomized control trial targeting parents of pediatric cancer survivors with obesity during the COVID-19 pandemic

Acadia W Buro; Heewon L Gray; Kathy Ruble; Sandra Soca Lozano; Rachel Sauls; Alexandra Albizu-Jacob; Sylvia L Crowder; Suzanne E Mazzeo; Marilyn Stern

doi:10.1093/tbm/ibac084

Challenges and adaptations for a cluster-randomized control trial targeting parents of pediatric cancer survivors with obesity during the COVID-19 pandemic

Transl Behav Med. 2023 Feb 28;13(2):98-103. doi: 10.1093/tbm/ibac084.

Authors

Acadia W Buro¹, Heewon L Gray², Kathy Ruble³, Sandra Soca Lozano⁴, Rachel Sauls⁵, Alexandra Albizu-Jacob⁶, Sylvia L Crowder¹, Suzanne E Mazzeo⁷, Marilyn Stern^{1

6}

Affiliations

¹ Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL, USA.
² College of Public Health, University of South Florida, Tampa, FL, USA.
³ Division of Pediatric Oncology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
⁴ College of Education, University of South Florida, Tampa, FL, USA.
⁵ Department of Psychology, College of Arts and Sciences, University of South Florida, Tampa, FL, USA.
⁶ Department of Child and Family Studies, College of Behavioral and Community Sciences, University of South Florida, Tampa, FL, USA.
⁷ Departments of Psychology and Pediatrics, Virginia Commonwealth University, Richmond, VA, USA.

Abstract

Although the COVID-19 pandemic has increased the importance of digital technology in clinical trial implementation, there is a dearth of literature reporting on challenges and strategies related to multi-site randomized controlled trials (RCTs) among pediatric cancer survivors during the pandemic. This paper discusses challenges faced in the implementation of the NOURISH-T+ trial so far (December 2019-March 2022) and describes adaptations made as a result of these disruptions in the areas of recruitment, data collection, and overall engagement. This reflection is based on a multisite cluster-RCT that aims to examine whether an intervention targeting parents as agents of change to promote healthy eating and physical activity in pediatric cancer survivors, NOURISH-T+ (Nourishing Our Understanding of Role modeling to Improve Support and Health for Healthy Transitions), reduces body mass and improves health behaviors compared to Brief NOURISH-T (Enhanced Usual Care/EUC). The COVID-19 pandemic has created and exacerbated challenges for our trial related to participant recruitment and engagement, technology access and literacy, and data collection and management, as well as COVID-related challenges (e.g., Zoom fatigue). Strategies used to address these challenges might prove helpful in future virtual or hybrid RCTs, including developing trust and rapport with participants, providing support through multiple routes of dissemination, and using data management applications (e.g., REDCap™) for automation and project management. Extra efforts to build families' trust and rapport, offering multiple routes of support, and automating as many tasks as possible are critical to ensuring the continuation of high-quality clinical trials during the COVID-19 pandemic.

Trial registration: ClinicalTrials.gov NCT04656496.

Keywords: COVID-19 pandemic; Cancer survivors; Pediatric; Randomized controlled trial; Virtual.

Plain language summary

Challenges and strategies among research on pediatric cancer survivors during the COVID-19 pandemic have not been well described. Our intervention, NOURISH-T+ (Nourishing Our Understanding of Role modeling to Improve Support and Health for Healthy Transitions), aims to promote healthy eating and physical activity in pediatric cancer survivors. The COVID-19 pandemic has created challenges for our trial related to participant recruitment and engagement, technology, data collection, and management, and COVID-related challenges (e.g., Zoom fatigue). Strategies that have been helpful for us include developing trust and rapport with participants, providing support through multiple routes of dissemination (e.g., website, videos), and using data management applications (e.g., REDCap™) to optimize tasks.

Publication types

Research Support, N.I.H., Extramural

MeSH terms

COVID-19*
Cancer Survivors*
Child
Health Behavior
Humans
Neoplasms* / therapy
Obesity
Parents
Pediatric Obesity* / therapy
Randomized Controlled Trials as Topic

Associated data

ClinicalTrials.gov/NCT04656496

Abstract

Plain language summary

Publication types

MeSH terms

Associated data

Grants and funding