Rehabilitation Including Social and Physical Activity in Children and Teenagers With Cancer (RESPECT)

• ClinicalTrials.gov Identifier: NCT01772862
• Recruitment Status: Unknown
• First Posted: January 21, 2013
• Last Update Posted: February 7, 2013
• Sponsor: Kjeld Schmiegelow
• Collaborators: Odense University Hospital; Aarhus University Hospital; Aalborg University Hospital
• Information provided by (Responsible Party): Kjeld Schmiegelow, Rigshospitalet, Denmark

Study Description

Brief Summary:

The purpose of this study is to determine whether early rehabilitation intervention including individualized physical training and social activities with a class mate at two weeks intervals at the ped.onc. center will increase children with cancer's level of physical performance

Condition or disease	Intervention/treatment	Phase
Childhood Cancer	Behavioral: Intervention group	Not Applicable

Detailed Description:

Background In Denmark 200 children under the age of 18 are diagnosed annually with cancer and the prevalence of patients undergoing anticancer therapy is 300. The expected five-year survival rate is 80%, but since the treatment is intensive with a high risk of life-threatening infections, these patients are frequently isolated at home or in hospital during their 1-2 years of therapy, which means reduced contact with their normal school environment, leisure activities and friends. Long-term survivors of childhood cancer frequently have compromised age-appropriate social relationships and psychosocial development, difficulties with resuming physical activities, and poor self-esteem leading to reduced quality of life. Intervention studies designed to improve physical and social function during treatment of children with cancer are lacking.

Aim To develop an interactive rehabilitation programme that a) preserve the educational, physical and psychosocial life of the patients or even obtains "growth with cancer", b) maintains the child's everyday life (e.g. normal social relationships), and c) improves long-term physical performance, social competences, higher grade educational enrollment, and later integration into the labour market.

Theoretical basis This project is inspired by Erving Goffman's interactional theory on normality and related concepts of stigma and frame analysis as well as Thomas Scheff's theory on the concept of emotional and social bonds and the development of the sociology of emotions.

Material and methods Intervention group: Children aged 6.0-18.0 years diagnosed with cancer 2013-2015 at Rigshospitalet (covers eastern part of Denmark (approximately 50% of total population)).

Control group:

The primary control group is children with cancer treated at the university hospitals in Odense, Aarhus and Aalborg 2013-2015.

In addition, outcome data for cases will be compared with three other (secondary) comparative groups: a) children with cancer treated at any Danish childhood oncology unit throughout Denmark in 2012 (historical controls); b) the sibling closest in age to the intervention group patients (family matched); and c) the intervention group patient's classmates.

Physical performance end point The physical performance will be monitored by: Andersen interval test, Timed up and go test, Sit to stand test, flamingo balance test, strength of hand by squeeze dynamometer and VO2 peak sub-max test.

Physical measures

Dexa scan

Questionnaires: PedsQL, Strength and Difficulties Questionnaire (SDQ), Revised Child anxiety and Depression Scale, Resilience, Loneliness and Social Dissatisfaction Questionnaire og The Children´s Impact of Event Scale 13.

Qualitative interviews: Qualitative interviews are performed with children with cancer, their parents, and the ambassadors. The focus will be on sociometric status, social independence and competences, self-esteem, fatigue, physical activity, educational outcome, and safety issues as well as an evaluation of the intervention program.

Outcomes and statistical considerations Provided all children with cancer (6-18 years) are included in the intervention or control group this study will be national cohort study including approximately 120 intervention children and 120 control children during the three year intervention period.

In relation to physical performance the power calculation is based on previous published small studies that found a baseline VO2peak of 24.3 (SD5.9) among children with ALL. If 120 children are included in the intervention and in the control group, then it the study will have a power or more than 0.85 to detect a 10% improvement and a power of 0.95 to detect a 15% improvement.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 240 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Rehabilitation Including Social and Education in Children and Teenagers With Cancer
• Study Start Date: January 2013
• Estimated Primary Completion Date: January 2019
• Estimated Study Completion Date: January 2019

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Only conventional supportive care; The children receive conventional supportive care with respect to physical training
Experimental: Intervention group; The intervention components includes (real time sequence): An educational session where the child is educated on his/her cancer disease. An education session in the child's school where the child´s teachers, classmates and their parents are educated on the child´s cancer disease. Appointment of two classmates as "ambassadors". An individualized physical training program combining supervised and non-supervised training 3-5 times per week. Continued specialized physical training when relevant. At two weeks intervals joined education, physical and social activity days at the hospital with together with one of the ambassadors	Behavioral: Intervention group; The intervention components includes (real time sequence): An educational session where the child is educated on his/her cancer disease. An education session in the child's school where the child´s teachers, classmates and their parents are educated on the child´s cancer disease. Appointment of two classmates as "ambassadors". An individualized physical training program combining supervised and non-supervised training 3-5 times per week. Continued specialized physical training when relevant. At two weeks intervals joined education, physical and social activity days at the hospital with together with one of the ambassadors; Other Name: Integrated physical training

Outcome Measures

Primary Outcome Measures :

1. Level of VO2 max [ Time Frame: 1 year after cessation of first-line cancer treatment ]
   We hypothesize that the children in the intervention group receiving a individualized physical training program three time a week during the intensive treatment period with surgery, irradiation or chemotherapy treatments will have a 10% higher VO2max level than children with cancer in the control group who do not receive such training

Secondary Outcome Measures :

1. Health quality of life [ Time Frame: Diagnosis, 6 months after diagnoses, 1 year post treatment ]
   Quality of life is assessed by questionnaires, and qualitative interviews

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Children diagnosed with cancer and treated at the pediatric oncology units in Denmark (Rigshospitalet, Odense University hospital, Aarhus University Hospital and Aalborg University Hospital)

Children diagnosed with non-malignant diseases treated with surgery, chemotherapy or irradiation similar to cancer (e.g. benign CNS tumors, langerhans cell histiocytosis, Myelodysplastic Syndrome (MDS)) and treated at the pediatric oncology units in Denmark (Rigshospitalet, Odense University hospital, Aarhus University hospital and Aalborg University Hospital).

Attend school at the time of diagnosis

Able to communicate in Danish

Exclusion Criteria:

• Mental retardation at the time of diagnosis (including Down syndrome) Terminal illness at the time of diagnoses Severe co-morbidity

Contacts and Locations

Contacts

Contact: Kjeld Schmiegelow, M.D; 0045 35451357; kjeld.schmiegelow@regionh.dk

Contact: Hanne Larsen, MS Sociology; 0045 35459647; hanne@baekgaard.com

Locations

Denmark

Kjeld Schmiegelow; Recruiting

Copenhagen, Denmark, 2100

Contact: Kejld Schmiegelow, MD +4535451357 kjeld.schmiegelow@regionh.dk

Contact: hanne Larsen, post.doc +4535459647

Sub-Investigator: hanne Larsen, post.doc

Sponsors and Collaborators

Kjeld Schmiegelow

Odense University Hospital

Aarhus University Hospital

Aalborg University Hospital

Investigators

• Study Director: Kjeld Schmiegelow, M.D; University Hospital of Copenhagen, Rigshospitalet

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nielsen MKF, Christensen JF, Frandsen TL, Thorsteinsson T, Andersen LB, Christensen KB, Wehner PS, Hasle H, Adamsen LO, Schmiegelow K, Larsen HB. Effects of a physical activity program from diagnosis on cardiorespiratory fitness in children with cancer: a national non-randomized controlled trial. BMC Med. 2020 Jul 6;18(1):175. doi: 10.1186/s12916-020-01634-6.

Nielsen MKF, Christensen JF, Frandsen TL, Thorsteinsson T, Andersen LB, Christensen KB, Nersting J, Faber M, Schmiegelow K, Larsen HB. Testing physical function in children undergoing intense cancer treatment-a RESPECT feasibility study. Pediatr Blood Cancer. 2018 Aug;65(8):e27100. doi: 10.1002/pbc.27100. Epub 2018 May 9.

Thorsteinsson T, Larsen HB, Schmiegelow K, Thing LF, Krustrup P, Pedersen MT, Christensen KB, Mogensen PR, Helms AS, Andersen LB. Cardiorespiratory fitness and physical function in children with cancer from diagnosis throughout treatment. BMJ Open Sport Exerc Med. 2017 May 12;3(1):e000179. doi: 10.1136/bmjsem-2016-000179. eCollection 2017.

Lindgren LH, Schmiegelow K, Helms AS, Thorsteinsson T, Larsen HB. In sickness and in health: classmates are highly motivated to provide in-hospital support during childhood cancer therapy. Psychooncology. 2017 Jan;26(1):37-43. doi: 10.1002/pon.4094. Epub 2016 Feb 12.

Thorsteinsson T, Helms AS, Adamsen L, Andersen LB, Andersen KV, Christensen KB, Hasle H, Heilmann C, Hejgaard N, Johansen C, Madsen M, Madsen SA, Simovska V, Strange B, Thing LF, Wehner PS, Schmiegelow K, Larsen HB. Study protocol: Rehabilitation including Social and Physical activity and Education in Children and Teenagers with Cancer (RESPECT). BMC Cancer. 2013 Nov 14;13:544. doi: 10.1186/1471-2407-13-544.

• Responsible Party: Kjeld Schmiegelow, Professor, Rigshospitalet, Denmark
• ClinicalTrials.gov Identifier: NCT01772862
• Other Study ID Numbers: RESPECT - physical activity; H-3-2012-105 ( Other Identifier: Ethical Review Board of Region Hovedstaden )
• First Posted: January 21, 2013
• Last Update Posted: February 7, 2013
• Last Verified: February 2013

Keywords provided by Kjeld Schmiegelow, Rigshospitalet, Denmark:

childhood; cancer; physical activity; quality of life