NCT05154305

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Apr 2019Dec 2026

Study Start

First participant enrolled

April 2, 2019

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 13, 2021

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

December 12, 2023

Status Verified

December 1, 2023

Enrollment Period

7.8 years

First QC Date

November 29, 2021

Last Update Submit

December 11, 2023

Conditions

Cancer SurvivorsRehabilitationExercise Therapy

Keywords

Multidisciplinary RehabilitationCohort studyChildhood and adolescence

Outcome Measures

Primary Outcomes (5)

  • Maximal exercise test

    Maximal exercise test on a cycle ergometer

    20 minutes

  • Body composition

    Body composition by dietitian

    5 minutes

  • Pediatric Quality of Life Inventory

    assessment Quality of Life

    10 minutes

  • Children's Assessment of Participation and Enjoyment (CAPE)

    assessment participation

    10 minutes

  • Preferences for Activities of Children (PAC)

    assessment preferred activities

    10 minutes

Study Arms (1)

Children 6 months post acute treatment

EXPERIMENTAL

children and adolescents between 6 months and 8 years post acute cancer treatment

Behavioral: multidisciplinary intervention

Interventions

multidisciplinary interventionBEHAVIORAL

* 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.

Children 6 months post acute treatment

Eligibility Criteria

Age8 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • between 6 months and 8 years post acute cancer treatment
  • off medical treatment
  • all possible cancer diagnosis, except for brain tumors and sarcomas

You may not qualify if:

  • not able to participate for 3 consecutive weeks
  • not able to perform a maximal cardiopulmonary exercise test
  • unwilling to cooperate
  • relapse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, B-9000, Belgium

RECRUITING

Related Publications (12)

  • 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.

    PMID: 19997035BACKGROUND

  • 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.

    PMID: 22121378BACKGROUND

  • 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.

    PMID: 22071396BACKGROUND

  • 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.

    PMID: 26378949BACKGROUND

  • 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.

    PMID: 21113771BACKGROUND

  • 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.

    PMID: 21570036BACKGROUND

  • 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.

    PMID: 25971213BACKGROUND

  • 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.

    PMID: 25285989BACKGROUND

  • 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.

    PMID: 24721685BACKGROUND

  • 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.

    PMID: 19415742BACKGROUND

  • 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.

    BACKGROUND

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

    BACKGROUND

Related Links

Study Officials

  • Catharina Dhooghe, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Catharina Dhooge, MD, PhD

CONTACT

00329/3322452CATHARINA.DHOOGE@UZGENT.BE

Ruth Van Der Looven, MD

CONTACT

00329/332.69.39RUTH.VANDERLOOVEN@UZGENT.BE

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2021

First Posted

December 13, 2021

Study Start

April 2, 2019

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

December 12, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)