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Recruitment and retention challenges and strategies in randomized controlled trials of psychosocial interventions for children with cancer and their parents: a collective case study

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European Journal of Pediatrics Aims and scope Submit manuscript

Abstract

In pediatric oncology there are few examples of successful recruitment and retention strategies in psychosocial care research. This study aims to summarize experiences, challenges, and strategies for conducting randomized controlled trials (RCTs) of psychosocial intervention studies among children with cancer and their parent(s). We conducted a collective case study. To identify the cases, Pubmed and two trial registries were searched for ongoing and finished RCTs of psychosocial intervention studies for children with cancer and their parents. Online semi-structured expert interviews discussing recruitment and retention challenges and strategies were performed with principal investigators and research staff members of the identified cases. Nine studies were identified. Investigators and staff from seven studies participated, highlighting challenges and strategies within three major themes: eligibility, enrollment and retention. Regarding eligibility, collaborating constructively with healthcare professionals and involving them before the start of the study were essential. Being flexible, training the research staff, enabling alignment with the participants’ situation, and providing consistency in contact between the research staff member and the families were important strategies for optimizing enrollment and retention. All studies followed a stepped process in recruitment.

  Conclusion: Although recruitment and retention in some selected studies were successful, there is a paucity of evidence on experienced recruitment and retention challenges in pediatric psychosocial research and best practices on optimizing them. The strategies outlined in this study can help researchers optimize their protocol and trial-implementation, and contribute to better psychosocial care for children with cancer and their parents.

  Trial Registration: This study is not a clinical trial.

What is Known:

• Performing RCTs is challenging, particularly in pediatric psychosocial research when both the child and parent are targeted. Recruitment and retention are common concerns. In pediatric oncology, there are few examples of successful recruitment and retention strategies in psychosocial care research.

What is New:

• Key strategies to collaborate constructively with healthcare professionals were outlined. Being flexible, training the research staff, alignment with the participant’s situations and providing consistency in contact between the research staff member and the families were considered as essential strategies.

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Data availability

Data are available from the corresponding author on reasonable request. 

Abbreviations

pACP:

Pediatric Advance Care Planning

RCT:

Randomized controlled trial

SWAT:

Study Within A Trial

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Acknowledgments

Thank you to research staff members Alison O’Daffer, Victoria Klein, Kelly Hancock, Hanin Salem, Jessica Thompkins, Sarah Friebert, Madeline Avery, Aurelie Joos and Kim Eecloo for their invaluable input on experienced recruitment challenges and strategies to overcome them. We would like to thank William Wright for language editing.

Funding

This study was supported by The Research Foundation – Flanders (FWO) [under grant Agreement G.0194.18 N] and Kinderkankerfonds [no grant number].

Author information

Authors and Affiliations

  1. End-of-Life Care Research Group, Vrije Universiteit Brussel (VUB) & Ghent University, Laarbeeklaan 103, 1090, Brussels, Belgium

    Anne van Driessche, Kim Beernaert, Luc Deliens, Joachim Cohen & Aline De Vleminck

  2. Department of Family Medicine and Chronic Care, Vrije Universiteit Brussel (VUB), 1090, Brussels, Belgium

    Kim Beernaert, Luc Deliens, Joachim Cohen & Aline De Vleminck

  3. Department of Public Health and Primary Care, Ghent University, 9000, Ghent, Belgium

    Kim Beernaert & Luc Deliens

  4. Center of Expertise Palliative Care Utrecht, Julius Center of Health and Primary Care, UMC Utrecht, Universiteitsweg 100, 3584, CG Utrecht, the Netherlands

    Marijke C. Kars

  5. Center for Translational Research, Children’s National Hospital, 111 Michigan Avenue, Washington, NW, DC 20010-2970, USA

    Maureen E. Lyon

  6. SickKids Hospital, Research Institute, Child Health and Evaluation Sciences, Toronto, ON, Canada

    Maru Barrera

  7. Pediatric Palliative Care, Research Mass General for Children, Boston, USA

    Veronica Dussel

  8. Danish Cancer Society Research Center, Psychological Aspects of Cancer, Copenhagen, Denmark

    Pernille Bidstrup

  9. Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, MA, USA

    Abby R. Rosenberg

  10. Department of Pediatric Palliative Care, Boston Children’s Hospital, Boston, MA, USA

    Abby R. Rosenberg

  11. Division of Hematology/Oncology, Department of Pediatrics, Harvard Medical School, Boston, MA, USA

    Abby R. Rosenberg

  12. Graduate School, Vanderbilt University, Nashville, TN, USA

    Terrah F. Akard

Authors
  1. Anne van Driessche
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  2. Kim Beernaert
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  3. Luc Deliens
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  4. Marijke C. Kars
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  5. Maureen E. Lyon
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  6. Maru Barrera
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  7. Veronica Dussel
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  8. Pernille Bidstrup
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  9. Abby R. Rosenberg
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  10. Terrah F. Akard
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  11. Joachim Cohen
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  12. Aline De Vleminck
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Contributions

All authors contributed to the study conception and design. Anne van Driessche performed the interviews and analysis, drafted the initial manuscript, and adapted the manuscript. Prof Kim Beernaert, Prof Joachim Cohen, Prof Luc Deliens, Dr Marijke C. Kars and Prof Aline De Vleminck critically reviewed and revised the manuscript. Dr Maureen E. Lyon, Dr Maru Barrera, Dr Veronica Dussel, Dr Pernille Bidstrup, Dr Abby R. Rosenberg and Dr Terrah F. Akard participated in the study as a respondent sharing expertise on the topic of interest, and critically reviewed and revised the manuscript.

Corresponding author

Correspondence to Anne van Driessche.

Ethics declarations

Ethics approval

The project this study is part of was approved by the Medical Ethics Committee of the University Hospital of Brussels in Flanders, Belgium (B1432020000177). The study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments and in compliance with our institutional guidelines.

Consent to participate

Informed consent was obtained from all individual participants included in the study.

Consent to publish

All respondents provided informed consent for publication of the study characteristics and use of quotes.

Competing interests

The authors declare no competing interests.

Additional information

Communicated by Peter de Winter

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Joachim Cohen and Aline De Vleminck shared last authorship.

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van Driessche, A., Beernaert, K., Deliens, L. et al. Recruitment and retention challenges and strategies in randomized controlled trials of psychosocial interventions for children with cancer and their parents: a collective case study. Eur J Pediatr 182, 4683–4706 (2023). https://doi.org/10.1007/s00431-023-05139-1

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