Parents' and Adolescents' Preferences for Intensified or Reduced Treatment in Randomized Lymphoblastic Leukemia Trials

Morten Tulstrup; Hanne Baekgaard Larsen; Anders Castor; Peter Rossel; Kathrine Grell; Mats Heyman; Jonas Abrahamsson; Stefan Söderhäll; Ann Åsberg; Olafur Gisli Jonsson; Kim Vettenranta; Thomas Leth Frandsen; Birgitte Klug Albertsen; K. Schmiegelow; Nordic Society of Paediatric Haematology, and Oncology (NOPHO)

doi:10.1002/pbc.25887

Parents' and Adolescents' Preferences for Intensified or Reduced Treatment in Randomized Lymphoblastic Leukemia Trials

Morten Tulstrup, Hanne Baekgaard Larsen, Anders Castor, Peter Rossel, Kathrine Grell, Mats Heyman, Jonas Abrahamsson, Stefan Söderhäll, Ann Åsberg, Olafur Gisli Jonsson, Kim Vettenranta, Thomas Leth Frandsen, Birgitte Klug Albertsen, K. Schmiegelow, Nordic Society of Paediatric Haematology, and Oncology (NOPHO)

5 Citations (Scopus)

Abstract

Background: When offered participation in clinical trials, families of children with cancer face a delicate balance between cure and toxicity. Since parents and children may perceive this balance differently, this paper explores whether adolescent patients have different enrollment patterns compared to younger children in trials with different toxicity profiles. Procedure: Age-dependent participation rates in three consecutive, randomized childhood leukemia trials conducted by the Nordic Society of Paediatric Haematology and Oncology were evaluated. The ALL2000 dexamethasone/vincristine (Dx/VCR) trial tested treatment intensifications to improve cure, and the back-to-back ALL2008 6-mercaptopurine (6MP) and ALL2008 PEG-asparaginase (ASP) trials tested treatment intensifications (6MP) and toxicity reduction without compromising survival (ASP). Patient randomization and toxicity data were prospectively registered by the treating physicians. Results: Parents of young children favored treatment intensifications (Dx/VCR: 12% refusal; 6MP: 14%; ASP: 21%), whereas parents of adolescents favored treatment reductions (Dx/VCR: 52% refusal; 6MP: 30%; ASP: 8%). Adolescents were more likely to refuse intensification trials than young children (adjusted ORs 6.3; P < 0.01 [Dx/VCR] and 2.1; P = 0.04 [6MP]). Adolescents were less likely to refuse the ASP trial, with varying effect size depending on the length of the preceding consolidation treatment (adjusted OR for median consolidation length 0.15; P = 0.01). Younger children participated more frequently in only 6MP than in only ASP (14% vs. 5%), and adolescents vice versa (2% vs. 17%; P = 0.001). Conclusions: Parents' and adolescents' divergent inclinations toward intensified or reduced therapy emphasize the necessity of actively involving adolescents in the informed consent process, which should also address motives for trial participation.

Original language	English
Journal	Pediatric Blood & Cancer
Volume	63
Issue number	5
Pages (from-to)	865–871
Number of pages	7
ISSN	1545-5009
DOIs	https://doi.org/10.1002/pbc.25887
Publication status	Published - 1 May 2016

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Tulstrup, M., Larsen, H. B., Castor, A., Rossel, P., Grell, K., Heyman, M., Abrahamsson, J., Söderhäll, S., Åsberg, A., Jonsson, O. G., Vettenranta, K., Frandsen, T. L., Albertsen, B. K., Schmiegelow, K., & Nordic Society of Paediatric Haematology, and Oncology (NOPHO) (2016). Parents' and Adolescents' Preferences for Intensified or Reduced Treatment in Randomized Lymphoblastic Leukemia Trials. Pediatric Blood & Cancer, 63(5), 865–871. https://doi.org/10.1002/pbc.25887

Tulstrup, M, Larsen, HB, Castor, A, Rossel, P , Grell, K, Heyman, M, Abrahamsson, J, Söderhäll, S, Åsberg, A, Jonsson, OG, Vettenranta, K, Frandsen, TL, Albertsen, BK, Schmiegelow, K & Nordic Society of Paediatric Haematology, and Oncology (NOPHO) 2016, 'Parents' and Adolescents' Preferences for Intensified or Reduced Treatment in Randomized Lymphoblastic Leukemia Trials', Pediatric Blood & Cancer, vol. 63, no. 5, pp. 865–871. https://doi.org/10.1002/pbc.25887

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title = "Parents' and Adolescents' Preferences for Intensified or Reduced Treatment in Randomized Lymphoblastic Leukemia Trials",

abstract = "Background: When offered participation in clinical trials, families of children with cancer face a delicate balance between cure and toxicity. Since parents and children may perceive this balance differently, this paper explores whether adolescent patients have different enrollment patterns compared to younger children in trials with different toxicity profiles. Procedure: Age-dependent participation rates in three consecutive, randomized childhood leukemia trials conducted by the Nordic Society of Paediatric Haematology and Oncology were evaluated. The ALL2000 dexamethasone/vincristine (Dx/VCR) trial tested treatment intensifications to improve cure, and the back-to-back ALL2008 6-mercaptopurine (6MP) and ALL2008 PEG-asparaginase (ASP) trials tested treatment intensifications (6MP) and toxicity reduction without compromising survival (ASP). Patient randomization and toxicity data were prospectively registered by the treating physicians. Results: Parents of young children favored treatment intensifications (Dx/VCR: 12% refusal; 6MP: 14%; ASP: 21%), whereas parents of adolescents favored treatment reductions (Dx/VCR: 52% refusal; 6MP: 30%; ASP: 8%). Adolescents were more likely to refuse intensification trials than young children (adjusted ORs 6.3; P < 0.01 [Dx/VCR] and 2.1; P = 0.04 [6MP]). Adolescents were less likely to refuse the ASP trial, with varying effect size depending on the length of the preceding consolidation treatment (adjusted OR for median consolidation length 0.15; P = 0.01). Younger children participated more frequently in only 6MP than in only ASP (14% vs. 5%), and adolescents vice versa (2% vs. 17%; P = 0.001). Conclusions: Parents' and adolescents' divergent inclinations toward intensified or reduced therapy emphasize the necessity of actively involving adolescents in the informed consent process, which should also address motives for trial participation.",

author = "Morten Tulstrup and Larsen, {Hanne Baekgaard} and Anders Castor and Peter Rossel and Kathrine Grell and Mats Heyman and Jonas Abrahamsson and Stefan S{\"o}derh{\"a}ll and Ann {\AA}sberg and Jonsson, {Olafur Gisli} and Kim Vettenranta and Frandsen, {Thomas Leth} and Albertsen, {Birgitte Klug} and K. Schmiegelow and {Nordic Society of Paediatric Haematology, and Oncology (NOPHO)}",

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TY - JOUR

T1 - Parents' and Adolescents' Preferences for Intensified or Reduced Treatment in Randomized Lymphoblastic Leukemia Trials

AU - Tulstrup, Morten

AU - Larsen, Hanne Baekgaard

AU - Castor, Anders

AU - Rossel, Peter

AU - Grell, Kathrine

AU - Heyman, Mats

AU - Abrahamsson, Jonas

AU - Söderhäll, Stefan

AU - Åsberg, Ann

AU - Jonsson, Olafur Gisli

AU - Vettenranta, Kim

AU - Frandsen, Thomas Leth

AU - Albertsen, Birgitte Klug

AU - Schmiegelow, K.

AU - Nordic Society of Paediatric Haematology, and Oncology (NOPHO)

PY - 2016/5/1

Y1 - 2016/5/1

N2 - Background: When offered participation in clinical trials, families of children with cancer face a delicate balance between cure and toxicity. Since parents and children may perceive this balance differently, this paper explores whether adolescent patients have different enrollment patterns compared to younger children in trials with different toxicity profiles. Procedure: Age-dependent participation rates in three consecutive, randomized childhood leukemia trials conducted by the Nordic Society of Paediatric Haematology and Oncology were evaluated. The ALL2000 dexamethasone/vincristine (Dx/VCR) trial tested treatment intensifications to improve cure, and the back-to-back ALL2008 6-mercaptopurine (6MP) and ALL2008 PEG-asparaginase (ASP) trials tested treatment intensifications (6MP) and toxicity reduction without compromising survival (ASP). Patient randomization and toxicity data were prospectively registered by the treating physicians. Results: Parents of young children favored treatment intensifications (Dx/VCR: 12% refusal; 6MP: 14%; ASP: 21%), whereas parents of adolescents favored treatment reductions (Dx/VCR: 52% refusal; 6MP: 30%; ASP: 8%). Adolescents were more likely to refuse intensification trials than young children (adjusted ORs 6.3; P < 0.01 [Dx/VCR] and 2.1; P = 0.04 [6MP]). Adolescents were less likely to refuse the ASP trial, with varying effect size depending on the length of the preceding consolidation treatment (adjusted OR for median consolidation length 0.15; P = 0.01). Younger children participated more frequently in only 6MP than in only ASP (14% vs. 5%), and adolescents vice versa (2% vs. 17%; P = 0.001). Conclusions: Parents' and adolescents' divergent inclinations toward intensified or reduced therapy emphasize the necessity of actively involving adolescents in the informed consent process, which should also address motives for trial participation.

AB - Background: When offered participation in clinical trials, families of children with cancer face a delicate balance between cure and toxicity. Since parents and children may perceive this balance differently, this paper explores whether adolescent patients have different enrollment patterns compared to younger children in trials with different toxicity profiles. Procedure: Age-dependent participation rates in three consecutive, randomized childhood leukemia trials conducted by the Nordic Society of Paediatric Haematology and Oncology were evaluated. The ALL2000 dexamethasone/vincristine (Dx/VCR) trial tested treatment intensifications to improve cure, and the back-to-back ALL2008 6-mercaptopurine (6MP) and ALL2008 PEG-asparaginase (ASP) trials tested treatment intensifications (6MP) and toxicity reduction without compromising survival (ASP). Patient randomization and toxicity data were prospectively registered by the treating physicians. Results: Parents of young children favored treatment intensifications (Dx/VCR: 12% refusal; 6MP: 14%; ASP: 21%), whereas parents of adolescents favored treatment reductions (Dx/VCR: 52% refusal; 6MP: 30%; ASP: 8%). Adolescents were more likely to refuse intensification trials than young children (adjusted ORs 6.3; P < 0.01 [Dx/VCR] and 2.1; P = 0.04 [6MP]). Adolescents were less likely to refuse the ASP trial, with varying effect size depending on the length of the preceding consolidation treatment (adjusted OR for median consolidation length 0.15; P = 0.01). Younger children participated more frequently in only 6MP than in only ASP (14% vs. 5%), and adolescents vice versa (2% vs. 17%; P = 0.001). Conclusions: Parents' and adolescents' divergent inclinations toward intensified or reduced therapy emphasize the necessity of actively involving adolescents in the informed consent process, which should also address motives for trial participation.

U2 - 10.1002/pbc.25887

DO - 10.1002/pbc.25887

M3 - Journal article

C2 - 26717887

SN - 1545-5009

VL - 63

SP - 865

EP - 871

JO - Pediatric Blood and Cancer

JF - Pediatric Blood and Cancer

IS - 5

ER -

Parents' and Adolescents' Preferences for Intensified or Reduced Treatment in Randomized Lymphoblastic Leukemia Trials

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