Multidisciplinary Rehabilitation of Children and Adolescents After Acute Cancer Treatment

Rehabilitation Clinical Trial

Official title:

Multidisciplinary Rehabilitation of Children and Adolescents After Acute Cancer Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05154305
• Other study ID #: 2018/0709
• Status: Recruiting
• Phase: N/A
• Start date: April 2, 2019
• Est. completion date: December 31, 2026

Study information

• Verified date: December 2023
• Source: University Hospital, Ghent
• Contact: Catharina Dhooge, MD, PhD
• Phone: 00329/3322452
• Email: CATHARINA.DHOOGE[@]UZGENT.BE
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Recent numbers display a 85% survival-rate in children after a very harmful disease such as cancer. However, the survivors still experience mild to severe side effects of the primary disease or treatment.

A long time follow-up in the University Hospital of Ghent in children with cancer displays important long term side effects such as: reduced muscle strength; reduced endurance capacity; reduced exercise tolerance; fatigue; disturbed body composition with increased risk for obesity and/or diabetes and osteoporosis; and neuropathic damage and myopathy. These physical complaints have a significant impact on the activities and participation in daily living.

The purpose of this interventional study is to create a rehabilitation program for children after acute cancer treatment. The goal is to minimalize the previous described long term side effects of the disease. The current study should allow us to determine the effects of the intervention at the level of functioning, activities and participation. In addition, we account for the environment and personal factors as described by the International Classification of Functioning, disability and health (ICF-criteria).

The study population consists of children between 8 and 11 years and adolescents of 12 to 21 years old. All participants receive a multidisciplinary treatment for 4 months, guided by a team which includes: oncologist, rehabilitation doctor, physical therapist, dietitian, psychologist, and occupational therapist.

At the beginning of the multidisciplinary program, the participants receive psychoeducation, diet advice, tips for participation, fatigue, and psychological well-being. In general, the rehabilitation program focusses on reintegration at school and leisure activity.

After the first assessment, an individually adjusted physical program consisting of strength and endurance training will be made. This physical program will be executed 3 times a week, 2 times guided by a physical therapist at the University Hospital or at a private practice, and ones a week by themselves at home recorded by an activity tracker. Follow-up is foreseen on monthly basis.

Participants will undergo assessment 3 times: 1) baseline (T0); 2) after 4 months treatment (T1); 3) after 1 year follow-up (T2).

The purpose of this program is to encourage patients at risk for increasing their healthy habits, exercise and participation in order to decrease long-term (side) effects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 21 Years

Eligibility

Inclusion Criteria:

• between 6 months and 8 years post acute cancer treatment

• off medical treatment

• all possible cancer diagnosis, except for brain tumors and sarcomas

Exclusion Criteria:

• not able to participate for 3 consecutive weeks

• not able to perform a maximal cardiopulmonary exercise test

• unwilling to cooperate

• relapse

Related Conditions & MeSH terms

• Cancer Survivors
• Exercise Therapy
• Rehabilitation

Intervention

Behavioral:
• multidisciplinary intervention
individually adjusted physical program consisting of strength and endurance training > 3 times a week, 2 times guided by a physical therapist at the University Hospital or at a private practice, and ones a week by themselves at home recorded by an activity tracker. Follow-up is foreseen on monthly basis. multidisciplinary coaching (discipline depending on personal needs of patient) on a monthly basis. These coaching sessions could be in small groups or individual.

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	VZW kinderkankerfonds, Belgium

Country where clinical trial is conducted

Belgium, 

References & Publications (12)

BONGERS, B.C., VAN BRUSSEL, M., HULZEBOS, E.H.J. & TAKKEN, T. (2014). PEDIATRIC NORMS FOR CARDIOPULMONARY EXERCISE TRAINING: IN RELATION TO SEX AND AGE (2ND ED.). UTRECHT: BOXPRESS.

Chamorro-Vina C, Ruiz JR, Santana-Sosa E, Gonzalez Vicent M, Madero L, Perez M, Fleck SJ, Perez A, Ramirez M, Lucia A. Exercise during hematopoietic stem cell transplant hospitalization in children. Med Sci Sports Exerc. 2010 Jun;42(6):1045-53. doi: 10.1249/MSS.0b013e3181c4dac1. — View Citation

Huang TT, Ness KK. Exercise interventions in children with cancer: a review. Int J Pediatr. 2011;2011:461512. doi: 10.1155/2011/461512. Epub 2011 Oct 27. — View Citation

Kelly AK. Physical activity prescription for childhood cancer survivors. Curr Sports Med Rep. 2011 Nov-Dec;10(6):352-9. doi: 10.1249/JSR.0b013e318237be40. — View Citation

Kotte EM, DE Groot JF, Bongers BC, Winkler AM, Takken T. Validity and Reproducibility of a New Treadmill Protocol: The Fitkids Treadmill Test. Med Sci Sports Exerc. 2015 Oct;47(10):2241-7. doi: 10.1249/MSS.0000000000000657. — View Citation

San Juan AF, Wolin K, Lucia A. Physical activity and pediatric cancer survivorship. Recent Results Cancer Res. 2011;186:319-47. doi: 10.1007/978-3-642-04231-7_14. — View Citation

Stark T, Walker B, Phillips JK, Fejer R, Beck R. Hand-held dynamometry correlation with the gold standard isokinetic dynamometry: a systematic review. PM R. 2011 May;3(5):472-9. doi: 10.1016/j.pmrj.2010.10.025. — View Citation

Steinberg A, Asher A, Bailey C, Fu JB. The role of physical rehabilitation in stem cell transplantation patients. Support Care Cancer. 2015 Aug;23(8):2447-60. doi: 10.1007/s00520-015-2744-3. Epub 2015 May 14. — View Citation

TAKKEN, T., VAN BRUSSEL, M., HULZEBOS., H.J., (2008). INSPANNINGSFYSIOLOGIE BIJ KINDEREN. HOUTEN: BOHN STAFLEU VAN LOGHUM.

van Dijk-Lokkart EM, Braam KI, Huisman J, Kaspers GJ, Takken T, Veening MA, Bierings M, Merks JH, Grootenhuis MA, van den Heuvel-Eibrink M, Streng IC, van Dulmen-den Broeder E. Factors influencing childhood cancer patients to participate in a combined physical and psychosocial intervention program: Quality of Life in Motion. Psychooncology. 2015 Apr;24(4):465-71. doi: 10.1002/pon.3677. Epub 2014 Oct 6. — View Citation

West SL, Gassas A, Schechter T, Egeler RM, Nathan PC, Wells GD. Exercise intolerance and the impact of physical activity in children treated with hematopoietic stem cell transplantation. Pediatr Exerc Sci. 2014 Aug;26(3):358-64. doi: 10.1123/pes.2013-0156. Epub 2014 Apr 10. — View Citation

Winter C, Muller C, Brandes M, Brinkmann A, Hoffmann C, Hardes J, Gosheger G, Boos J, Rosenbaum D. Level of activity in children undergoing cancer treatment. Pediatr Blood Cancer. 2009 Sep;53(3):438-43. doi: 10.1002/pbc.22055. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal exercise test	Maximal exercise test on a cycle ergometer	20 minutes
Primary	Body composition	Body composition by dietitian	5 minutes
Primary	Pediatric Quality of Life Inventory	assessment Quality of Life	10 minutes
Primary	Children's Assessment of Participation and Enjoyment (CAPE)	assessment participation	10 minutes
Primary	Preferences for Activities of Children (PAC)	assessment preferred activities	10 minutes

External Links

•   project description on sponsor's website