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Cancer SurvivorsNCT05154305

Multidisciplinary Rehabilitation of Children and Adolescents After Acute Cancer Treatment

A study testing multidisciplinary intervention in people with Cancer Survivors and Rehabilitation, run by University Hospital, Ghent at 1 site in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 8 to 21 years
Conditions the study is for
Cancer Survivors, Rehabilitation, Exercise Therapy
What is being tested?
multidisciplinary intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteBelgium
Study dates
2 Apr 2019to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Catharina Dhooge, MD, PhD contact

00329/3322452

CATHARINA.DHOOGE@UZGENT.BE

Ruth Van Der Looven, MD contact

00329/332.69.39

RUTH.VANDERLOOVEN@UZGENT.BE

Belgium1 site, 1 recruiting

  • Ghent University Hospital

    Ghent, B-9000

    Elise De Vos, MSc, 00329/332.22.24, elise.devos@uzgent.be

    Hanne Capiau, MSc, 00329/3320597, Hanne.Capiau@UZGENT.be

    Recruiting

Other trials in Belgium

About this study

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.

Read more

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.

Being tested
multidisciplinary intervention
Keywords
Multidisciplinary Rehabilitation, Cohort study, Childhood and adolescence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • multidisciplinary interventionBehavioural

    • 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.
Study groups in NCT05154305
Study groupRoleWhat they receive
Children 6 months post acute treatmentExperimentalchildren and adolescents between 6 months and 8 years post acute cancer treatment
Receives: Behavioral: multidisciplinary intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximal exercise test

    Maximal exercise test on a cycle ergometer

    Measured: 20 minutes

  2. Body composition

    Body composition by dietitian

    Measured: 5 minutes

  3. Pediatric Quality of Life Inventory

    assessment Quality of Life

    Measured: 10 minutes

  4. Children's Assessment of Participation and Enjoyment (CAPE)

    assessment participation

    Measured: 10 minutes

  5. Preferences for Activities of Children (PAC)

    assessment preferred activities

    Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2021
  2. Study start2 Apr 2019
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05154305
Sponsor's protocol ID
2018/0709
Status last verified
Dec 2023
First submitted
29 Nov 2021
Last updated
12 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19997035

  • 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.

    PubMed 22121378

  • 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.

    PubMed 22071396

  • 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.

    PubMed 26378949

  • 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.

    PubMed 21113771

  • 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.

    PubMed 21570036

  • 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.

    PubMed 25971213

  • 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.

    PubMed 25285989

  • 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.

    PubMed 24721685

  • 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.

    PubMed 19415742

  • 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.

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

Questions about this trial

What is this clinical trial studying?

A study testing multidisciplinary intervention in people with Cancer Survivors and Rehabilitation, run by University Hospital, Ghent at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Catharina Dhooge, MD, PhD (00329/3322452, CATHARINA.DHOOGE@UZGENT.BE), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal exercise test (time frame: 20 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05154305, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.

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