Childhood CancerRESPECT-EDUNCT01772849
Rehabilitation Including Social Activity and Education in Children and Teenagers With Cancer
A study testing Intervention group in people with Childhood Cancer, run by Kjeld Schmiegelow at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Childhood Cancer
- What is being tested?
- Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesDenmark
- Study dates
- Jan 2013to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Mental retardation at the time of diagnosis (including Down syndrome). Terminal illness at the time of diagnoses. Severe co-morbidity.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Recruiting
Kjeld Schmiegelow
Copenhagen, 2100
Kjeld Schmiegelow, M.D, 004535451357, kjeld.schmiegelow@regionh.dk
Hanne B Larsen, MS Sociology, 0045 35459647, hanne@baekgaard.com
- Recruiting
Kjeld Schmiegelow
Copenhagen, 2100
Kjeld Schmiegelow, M.D, 004535451357, kjeld.schmiegelow@regionh.dk
Hanne Larsen, MS sociology, 004535459647, hanne@baekgaard.com
About this study
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.
Read the 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.
- Conditions
- Childhood Cancer
- Being tested
- Intervention group
- Keywords
- childhood, cancer, education, physical activity, quality of life
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupBehavioural
Also called Integrated education acitivity
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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 Receives: Behavioral: Intervention group |
| Standard educational programme | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of educational achievement
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.
Measured: 1 year after cessation of first-line cancer treatment
Secondary outcomes (1)
Quality of life
Quality of life is assessed by questionnaires, and qualitative interviews
Measured: diagnosis, 6 months after diagnoses, 1 year post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kjeld Schmiegelow
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kjeld Schmiegelow, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Kjeld Schmiegelow, M.D, Study director, University Hospital of Copenhagen, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01772849
- Sponsor's protocol ID
- RESPECT - education
- Other IDs
- H-3-2012-105
- Acronym
- RESPECT-EDU
- Status last verified
- Feb 2013
- First submitted
- 11 Jan 2013
- Last updated
- 7 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32624004Lindgren 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.
PubMed 26872002Thorsteinsson 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.
PubMed 24229362
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation Including Social Activity and Education in Children and Teenagers With Cancer
- ClinicalTrials.gov ID
- NCT01772849
- Acronym / sponsor ID
- RESPECT-EDU / RESPECT - education
- Conditions
- Childhood Cancer
- Keywords
- childhood, cancer, education, physical activity, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Kjeld SchmiegelowUniversity, hospital or other
- Collaborators
- Odense University Hospital, Aarhus University Hospital, Aalborg University Hospital
- Study start
- Jan 2013
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 21 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Intervention groupThe 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 |
| Standard educational programme | No intervention | –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 |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Mental retardation at the time of diagnosis (including Down syndrome). Terminal illness at the time of diagnoses. Severe co-morbidity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention groupAlso: Integrated education acitivityThe 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 | Behavioural | Intervention group |
Primary outcome
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.
1 secondary outcome
Quality of life
Time frame: diagnosis, 6 months after diagnoses, 1 year post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2013.
- Derived from this study: PubMed 32624004Nielsen 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.
- Derived from this study: PubMed 26872002Lindgren 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.
- Derived from this study: PubMed 24229362Thorsteinsson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kjeld Schmiegelow, M.D study director
University Hospital of Copenhagen, Rigshospitalet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Childhood Cancer, run by Kjeld Schmiegelow at 2 sites in Denmark.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kjeld Schmiegelow, M.D (0045 35451357, kjeld.schmiegelow@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of educational achievement (time frame: 1 year after cessation of first-line cancer treatment). 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 NCT01772849, which also lists 3 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 7 Feb 2013.