TY - JOUR
T1 - Advance care planning for adolescents with cancer and their parents
T2 - study protocol of the BOOST pACP multi-centre randomised controlled trial and process evaluation
AU - van Driessche, Anne
AU - De Vleminck, Aline
AU - Gilissen, Joni
AU - Kars, Marijke C
AU - van der Werff Ten Bosch, Jutte
AU - Deliens, Luc
AU - Cohen, Joachim
AU - Beernaert, Kim
N1 - Funding Information:
The research team would like to thank those involved in the development of the BOOST pACP program, the adolescents and young adults, parents and healthcare professionals that tested the program materials; colleagues from the End-of-Life Care Research Group, Jurrianne Fahner and facilitators Charlotte Kerstens and Jill Schietse for their feedback on the BOOST pACP program and development process; Wilde Kastanje for their role in the communication training of the facilitators; Kim Eecloo, Aurelie Joos, Dr. Joris Verlooy, Toke Michielsen and Nina Severijns (UZ Antwerpen), Dr. Marleen Renard and Gertrui Vercruysse (UZ Leuven) and Prof. Geneviève Laureys, Dr. Leen Willems and Hanne Morren (UZ Gent) for their input and efforts in recruitment; Wilfried Cools (Vrije Universiteit Brussel) for his support in the randomization procedure; Ellen Deschepper (Statcel, University Ghent) for her help with the statistical analysis plan; and Jane Ruthven for language editing.
Funding Information:
This project is supported by the Research Foundation – Flanders [under grant Agreement G.0194.18 N] and by Kinderkankerfonds [no grant number] and has undergone peer review by both funding bodies. Aline De Vleminck and Kim Beernaert are postdoctoral research fellows supported by the Research Foundation – Flanders. Joni Gilissen is a postdoctoral research fellow supported by the Maurange fund (King Baudouin Foundation). None of the funders had and will have any role in the design of the study and collection, analysis and interpretation of data and in writing the manuscript.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/9/1
Y1 - 2021/9/1
N2 - BACKGROUND: Research has highlighted the need for evidence-based interventions to improve paediatric advance care planning (pACP) in adolescents with cancer. Although adolescents express the desire and ability to share their values, beliefs and preferences for treatment, there is a lack of structured multicomponent interventions to improve parent-adolescent communication on different ACP themes including those not limited to end-of-life care. The aim of this study is to evaluate the effectiveness and implementation, context and mechanisms of impact of a novel ACP program in paediatric oncology.METHODS: We will conduct a multi-centre parallel-group randomised controlled superiority trial with embedded mixed-methods process evaluation in Flanders, Belgium. Adolescents aged 10-18 who have cancer, and their parent(s) will be recruited via all four university hospitals in Flanders, Belgium, and support groups. Families will be randomised to receive care as usual or the multicomponent BOOST pACP program, consisting of three conversation sessions between an external facilitator and the adolescent and parent(s). The primary endpoint is improved parent-adolescent communication from the perspective of the adolescent. Secondary endpoints are adolescents' and parents' attitudes, self-efficacy, intention and behaviour regarding talking about ACP themes with each other, parents' perspective of shared decision making in the last clinical encounter, and the paediatric oncologist's intention and behaviour regarding talking about ACP themes with the family. Measurements will be performed at baseline, at 3 months and at 7 months using structured self-reported questionnaires. We will perform a process evaluation in the intervention group, with measurement throughout and post-intervention, using structured diaries filled out by the facilitators, interviews with facilitators, interviews with involved paediatric oncology teams, and audio-recordings of the BOOST pACP conversations.DISCUSSION: The BOOST pACP program has been developed to stimulate conversations on ACP themes between parent(s) and the adolescents, simultaneously lowering the threshold to discuss similar themes with healthcare professionals, initiating a process of normalization and integration of ACP in standard care. This combined outcome and process evaluation aims to contribute to building the necessary evidence to improve ACP in paediatric oncology.TRIAL REGISTRATION: The study is registered at ISRCTN, ISRCTN33228289 . Registration date: January 22, 2021.
AB - BACKGROUND: Research has highlighted the need for evidence-based interventions to improve paediatric advance care planning (pACP) in adolescents with cancer. Although adolescents express the desire and ability to share their values, beliefs and preferences for treatment, there is a lack of structured multicomponent interventions to improve parent-adolescent communication on different ACP themes including those not limited to end-of-life care. The aim of this study is to evaluate the effectiveness and implementation, context and mechanisms of impact of a novel ACP program in paediatric oncology.METHODS: We will conduct a multi-centre parallel-group randomised controlled superiority trial with embedded mixed-methods process evaluation in Flanders, Belgium. Adolescents aged 10-18 who have cancer, and their parent(s) will be recruited via all four university hospitals in Flanders, Belgium, and support groups. Families will be randomised to receive care as usual or the multicomponent BOOST pACP program, consisting of three conversation sessions between an external facilitator and the adolescent and parent(s). The primary endpoint is improved parent-adolescent communication from the perspective of the adolescent. Secondary endpoints are adolescents' and parents' attitudes, self-efficacy, intention and behaviour regarding talking about ACP themes with each other, parents' perspective of shared decision making in the last clinical encounter, and the paediatric oncologist's intention and behaviour regarding talking about ACP themes with the family. Measurements will be performed at baseline, at 3 months and at 7 months using structured self-reported questionnaires. We will perform a process evaluation in the intervention group, with measurement throughout and post-intervention, using structured diaries filled out by the facilitators, interviews with facilitators, interviews with involved paediatric oncology teams, and audio-recordings of the BOOST pACP conversations.DISCUSSION: The BOOST pACP program has been developed to stimulate conversations on ACP themes between parent(s) and the adolescents, simultaneously lowering the threshold to discuss similar themes with healthcare professionals, initiating a process of normalization and integration of ACP in standard care. This combined outcome and process evaluation aims to contribute to building the necessary evidence to improve ACP in paediatric oncology.TRIAL REGISTRATION: The study is registered at ISRCTN, ISRCTN33228289 . Registration date: January 22, 2021.
KW - Adolescent
KW - Advance care planning
KW - Communication
KW - Multi-Centre randomised controlled trial
KW - Paediatric oncology
KW - Paediatric palliative care
KW - Parent-adolescent communication
UR - http://www.scopus.com/inward/record.url?scp=85114032259&partnerID=8YFLogxK
U2 - 10.1186/s12887-021-02841-7
DO - 10.1186/s12887-021-02841-7
M3 - Article
C2 - 34470598
SN - 1471-2431
VL - 21
JO - BMC Pediatrics
JF - BMC Pediatrics
IS - 1
M1 - 376
ER -