Rehabilitation Including Social Activity and Education in Children and Teenagers With Cancer (RESPECT-EDU)

• ClinicalTrials.gov Identifier: NCT01772849
• 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 educational and social activities with a class mate at two weeks intervals at the ped.onc. center will increase children with cancer's level of education 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.

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.

If the children´s academic performance are divided into five categories (unsatisfactory to outstanding level of performance) with a distribution of performance on the five categories as 10 %; 20 %; 40 %; 20 %; 10 % and where a change from one category to another are regarded as a significant change in the child´s academic performance, it is possible to achieve a strength over 0.90 to detect a change of the average by 0.5 if 120 children are included.

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 Activity 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
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" Continued individualized education at the hospital school or at home that parallels/copies the educational curriculum in the child regular school At two weks intervals joined education, physical (separate study) 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" Continued individualized education at the hospital school or at home that parallels/copies the educational curriculum in the child regular school At two weks intervals joined education, physical (separate study) and social activity days at the hospital with together with one of the ambassadors; Other Name: Integrated education acitivity
No Intervention: Standard educational programme; The children receive the standard of care with respect to education this include education in the hospitals school or at home without a class mate and no specific activity to secure continuous linkage with community school and class mates

Outcome Measures

Primary Outcome Measures :

1. Level of educational achievement [ Time Frame: 1 year after cessation of first-line cancer treatment ]
   The child´s level of education in Danish (1. language and reading) and math is measured on a five point scale including outstanding level of performance, high level of performance, satisfactory level of performance, needs improvement in level of performance, and unsatisfactory level of performance. Maximum 10% of the children in the intervention group receiving the integrated education program with their regular class mate's will experience a decrease of one or more levels on the five point performance scale.

Secondary Outcome Measures :

1. 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 B Larsen, MS Sociology; 0045 35459647; hanne@baekgaard.com

Locations

Denmark

Kjeld Schmiegelow; Recruiting

Copenhagen, Denmark, 2100

Contact: Kjeld Schmiegelow, M.D 004535451357 kjeld.schmiegelow@regionh.dk

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

Principal Investigator: Kjeld Schmiegelow, M.D

Kjeld Schmiegelow; Recruiting

Copenhagen, Denmark, 2100

Contact: Kjeld Schmiegelow, M.D 004535451357 kjeld.schmiegelow@regionh.dk

Contact: Hanne Larsen, MS sociology 004535459647 hanne@baekgaard.com

Principal Investigator: Kjeld Schmiegelow, M.D

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.

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: NCT01772849
• Other Study ID Numbers: RESPECT - education; 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; education; physical activity; quality of life