TY - JOUR
T1 - Design of the Quality of Life in Motion (QLIM) study
T2 - a randomized controlled trial to evaluate the effectiveness and cost-effectiveness of a combined physical exercise and psychosocial training program to improve physical fitness in children with cancer
AU - Braam, Katja I
AU - van Dijk, Elisabeth M
AU - Veening, Margreet A
AU - Bierings, Marc B
AU - Merks, Johannes H M
AU - Grootenhuis, Martha A
AU - Chinapaw, Mai J M
AU - Sinnema, Gerben
AU - Takken, Tim
AU - Huisman, Jaap
AU - Kaspers, Gertjan J L
AU - van Dulmen-den Broeder, Eline
N1 - Funding Information:
All authors contributed to the study design (with the exception of MAG and JHM who reinforced the QLIM study at a later stage). KIB and EMD are responsible for patient recruitment and data collection. KIB coordinates the logistics of the physical intervention and EMD, who developed the psychosocial intervention, coordinates the psychosocial intervention and performs the psychosocial interventions at the VU University Medical Center. Both KIB and EMD wrote the manuscript and contributed equally; GJK, JHU and TTA are principal investigators. GJK is the overall project leader. JHU leads the psychosocial content of the study; TTA developed the physical intervention and is the paediatric exercise physiology leader of the study; MAV, MBB and JHM are paediatric oncologists and clinically responsible for, respectively, the VU University Medical Center, the Wilhelmina Children’s Hospital/University Medical Center Utrecht and the Emma Children’s Hospital/ Academic Medical Centre, Amsterdam; GSI and MAG are responsible for the psychosocial interventions in, respectively, the Wilhelmina Children’s Hospital/ University Medical Center Utrecht and the Emma Children’s Hospital/ Academic Medical Centre, Amsterdam; MCP directs the four A-CaRe trials; EVD was responsible for writing the grant proposal for funding from the Dutch Cancer Society. All authors contributed to and approved the final manuscript.
Funding Information:
This study is part of the A-CaRe Program, http://www.a-care.org. The authors acknowledge the A-CaRe Clinical Research Group. The research is supported by the Alpe d’HuZes/KWF Fund. The research grant is bestowed upon the Dutch Cancer Society (grant number ALPE-VU 2009-4305), the RopaRun and the VUmc Childhood Cancer Research Foundation (VONK).
PY - 2010/11/11
Y1 - 2010/11/11
N2 - BACKGROUND: Childhood cancer and its treatment have considerable impact on a child's physical and mental wellbeing. Especially long-term administration of chemotherapy and/or radiotherapy impairs physical fitness both during and after therapy, when children often present with muscle weakness and/or low cardiorespiratory fitness. Physical exercise can improve these two elements of physical fitness, but the positive effects of physical exercise might be further increased when a child's wellbeing is simultaneously enhanced by psychosocial training. Feeling better may increase the willingness and motivation to engage in sports activities. Therefore, this multi-centre study evaluates the short and long-term changes in physical fitness of a child with a childhood malignancy, using a combined physical exercise and psychosocial intervention program, implemented during or shortly after treatment. Also examined is whether positive effects on physical fitness reduce inactivity-related adverse health problems, improve quality of life, and are cost-effective.METHODS: This multi-centre randomized controlled trial compares a combined physical and psychosocial intervention program for children with cancer, with care as usual (controls). Children with cancer (aged 8-18 years) treated with chemotherapy and/or radiotherapy, and who are no longer than 1 year post-treatment, are eligible for participation. A total of 100 children are being recruited from the paediatric oncology/haematology departments of three Dutch university medical centres. Patients are stratified according to pubertal stage (girls: age ≤10 or >10 years; boys: ≤11 or >11 years), type of malignancy (haematological or solid tumour), and moment of inclusion into the study (during or after treatment), and are randomly assigned to the intervention or control group.DISCUSSION: Childhood cancer patients undergoing long-term cancer therapy may benefit from a combined physical exercise and psychosocial intervention program since it may maintain or enhance their physical fitness and increase their quality of life. However, the feasibility, patient need, and effectiveness of such a program should be established before the program can be implemented as part of standard care.TRIAL REGISTRATION NUMBER: NTR1531 (The Netherlands National Trial Register).
AB - BACKGROUND: Childhood cancer and its treatment have considerable impact on a child's physical and mental wellbeing. Especially long-term administration of chemotherapy and/or radiotherapy impairs physical fitness both during and after therapy, when children often present with muscle weakness and/or low cardiorespiratory fitness. Physical exercise can improve these two elements of physical fitness, but the positive effects of physical exercise might be further increased when a child's wellbeing is simultaneously enhanced by psychosocial training. Feeling better may increase the willingness and motivation to engage in sports activities. Therefore, this multi-centre study evaluates the short and long-term changes in physical fitness of a child with a childhood malignancy, using a combined physical exercise and psychosocial intervention program, implemented during or shortly after treatment. Also examined is whether positive effects on physical fitness reduce inactivity-related adverse health problems, improve quality of life, and are cost-effective.METHODS: This multi-centre randomized controlled trial compares a combined physical and psychosocial intervention program for children with cancer, with care as usual (controls). Children with cancer (aged 8-18 years) treated with chemotherapy and/or radiotherapy, and who are no longer than 1 year post-treatment, are eligible for participation. A total of 100 children are being recruited from the paediatric oncology/haematology departments of three Dutch university medical centres. Patients are stratified according to pubertal stage (girls: age ≤10 or >10 years; boys: ≤11 or >11 years), type of malignancy (haematological or solid tumour), and moment of inclusion into the study (during or after treatment), and are randomly assigned to the intervention or control group.DISCUSSION: Childhood cancer patients undergoing long-term cancer therapy may benefit from a combined physical exercise and psychosocial intervention program since it may maintain or enhance their physical fitness and increase their quality of life. However, the feasibility, patient need, and effectiveness of such a program should be established before the program can be implemented as part of standard care.TRIAL REGISTRATION NUMBER: NTR1531 (The Netherlands National Trial Register).
KW - Adolescent
KW - Child
KW - Cost-Benefit Analysis
KW - Exercise/physiology
KW - Exercise Therapy/economics
KW - Female
KW - Humans
KW - Male
KW - Neoplasms/psychology
KW - Physical Fitness/physiology
KW - Quality of Life
KW - Regression Analysis
KW - Treatment Outcome
UR - http://www.scopus.com/inward/record.url?scp=78649761706&partnerID=8YFLogxK
U2 - 10.1186/1471-2407-10-624
DO - 10.1186/1471-2407-10-624
M3 - Article
C2 - 21070639
SN - 1471-2407
VL - 10
SP - 624
JO - BMC cancer
JF - BMC cancer
M1 - 624
ER -