Childhood CancerACCSNCT04284189
Aftercare of Childhood Cancer Survivors in Switzerland
An observational study of Childhood Cancer and Survivorship, run by Kantonsspital Aarau at 3 sites in Switzerland.
Trial summary
The Aftercare of Childhood Cancer Survivors in Switzerland (ACCS) study is a multicenter cohort study designed to investigate transition of follow-up care from pediatric oncology to adult care in a prospective and longitudinal way. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Childhood Cancer, Survivorship, Transition
- What is being tested?
- Transition model
- How many people
- 140 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 12 Feb 2019to Aug 2030
- Phase
- Observational
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of childhood cancer survivors, who were diagnosed in three Swiss pediatric oncology centers at age <18 years and are ≥5-year from diagnosis and age ≥16 years at study inclusion. Additionally, survivors are at study start in follow-up care at one of the three pediatric oncology centers (group before transition) or have been transitioned to adult care not before 2014 (group after transition)
Who may be able to join
- 5-year survivor of childhood cancer
- Diagnosis according to ICCC3 I-XII; Langerhans cell histiocytosis (LCH), Hemophagocytic lymphohistiocytosis (HLH)
- Age at diagnosis <18 years
- Age at study ≥16 years
- At study start in follow-up care at one of the three pediatric oncology centers (group before transition) or transitioned not before 2014 (group after transition).
- Written informed consent
Who cannot join
- Treatment only by means of surgery and without increased risk of late effects (e.g. teratoma)
- <5 years after therapy of a relapse or palliative situation
- Severe cognitive impairment, which makes it impossible to complete the questionnaire independently
- Insufficient knowledge of the German language
- Informed consent form not signed
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland3 sites, 3 recruiting
- Recruiting
Division of Oncology - Hematology, Department of Pediatrics, Kantonsspital Aarau
Aarau
Katrin Scheinemann, MD
Katrin Scheinemann, MD
- Recruiting
Division of Oncology/ Hematology, University Children's Hospital Basel
Basel
Tamara Diesch, MD
Tamara Diesch, MD
- Recruiting
Division of Oncology/ Hematology, Department of Pediatrics, Kantonsspital Lucerne
Lucerne
Bernhard Eisenreich, MD
Bernhard Eisenreich, MD
About this study
Official title: Aftercare of Childhood Cancer Survivors in Switzerland - the ACCS Switzerland Project
The Aftercare of Childhood Cancer Survivors in Switzerland (ACCS) study is a multicenter cohort study designed to investigate transition of follow-up care from pediatric oncology to adult care in a prospective and longitudinal way. The investigators collect data on preferences and expectations for follow-up care and transition to adult care by questionnaires in adolescent and young adult survivors of childhood cancer.
Read the detailed description
Background: Every year over 300 children and adolescents up to the age of 18 years are newly diagnosed with cancer in Switzerland. Survival after childhood cancer has increased substantially over the last decades and 10-year survival now exceeds 85%. This results in an increasing numbers of childhood cancer survivors - currently around 7,000 survivors in Switzerland. Due to cancer treatment or the cancer itself, a large part of the childhood cancer survivors suffers from late effects. Early diagnosis and intervention can reduce morbidity and mortality due to late effects. Therefore, regular follow-up care, even beyond childhood, is very important, but transition from pediatric to adult follow-up care is a critical point. In Switzerland there are very different aftercare and transition models, although it is unclear which aftercare strategy is the best and meets the needs of survivors. The Aftercare of Childhood Cancer Survivors (ACCS) study aims to fill this gap.
Objectives: The main objective of the ACCS study is to identify the current needs of adolescent and young adult long-term survivors in terms of follow-up care by comparing three different transition practices. The secondary objective is to assess survivors' knowledge on their diagnosis, therapy and follow-up examinations longitudinally.
Methods: ACCS is a multicenter questionnaire-based study, including survivors from three pediatric oncology centers in Switzerland. Eligible survivors who already transitioned to adult care at start of the study once receive a letter explaining the purpose of the study, the study information, the informed consent form, and the questionnaire. The questionnaire asks about cancer knowledge and additionally includes validated scales on cancer worry, self-management skills, ongoing care, and expectations. The survivors send the documents back by a prepaid envelope. Eligible survivors before transition to adult care at start of the study receive a letter explaining the purpose of the study, the study information and informed consent form, and the first questionnaire two to four weeks before the next scheduled follow-up visit. They can either send the documents back before the visit or bring them to the visit. The participants receive three month after the visit a short questionnaire to assess cancer knowledge. Three month after the follow-up visit after transition (15 month after last visit in pure pediatric setting), the participants receive the first comprehensive questionnaire again.
Rationale and significance: There are very different aftercare and transition models in Switzerland, although it is unclear which follow-up care strategy best meets the needs of survivors. The data collected within the ACCS study helps to define which transition and follow-up care strategies and related factors are favoured by adolescent and young adult survivors. Adaption of transition processes to the needs of survivors improve adherence to follow-up care of adult childhood cancer survivors. As late effects increase with increasing time from treatment, adult survivors of childhood cancer are at particular risk to develop late effects and it is important that they continue follow-up care.
- Conditions
- Childhood Cancer, Survivorship, Transition
- Being tested
- Transition model
- Keywords
- Childhood Cancer Survivor, Transition of follow-up care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transition modelOther
Transition of follow-up care of childhood cancer survivors to adult care
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer Worry as part of transition readiness
Assessment via validated "Cancer Worry Scale"
Measured: Change from baseline to 3 month and 15 month
Self-management as part of transition readiness
Assessment via validated "Self-Management Skill Scale"
Measured: Change from baseline to 3 month and 15 month
Evaluation of needs for ongoing care as part of transition readiness
Assessment via validated "Scale for ongoing Care"
Measured: Change from baseline to 3 month and 15 month
Evaluation of expectation for transition as part of transition readiness
Assessment via validated "Expectation Scale"
Measured: Change from baseline to 3 month and 15 month
Secondary outcomes (1)
Survivors' cancer specific knowledge
Assessment via questionnaire
Measured: Change from baseline to 3 month and 15 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start12 Feb 2019
- Primary completionApr 2025 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Aarau
- Sponsor type
- University, hospital or other
- Collaborators
- University Children's Hospital Basel, Luzerner Kantonsspital
- Responsible party
- Principal investigator, Katrin Scheinemann, Kantonsspital Aarau
- Investigators
- Katrin Scheinemann, MD, Principal investigator, Kantonsspital Aarau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284189
- Sponsor's protocol ID
- 2018-02304
- Other IDs
- 2018
- Acronym
- ACCS
- Status last verified
- Aug 2022
- First submitted
- 20 Feb 2020
- Last updated
- 17 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Otth M, Kroiss-Benninger S, Scheinemann K. Aftercare of Childhood Cancer Survivors in Switzerland-The General Practitioner Model. J Adolesc Young Adult Oncol. 2025 Feb;14(1):53-61. doi: 10.1089/jayao.2024.0059. Epub 2024 Aug 12.
PubMed 39133122Denzler S, Otth M, Scheinemann K. Aftercare of Childhood Cancer Survivors in Switzerland: Protocol for a Prospective Multicenter Observational Study. JMIR Res Protoc. 2020 Aug 26;9(8):e18898. doi: 10.2196/18898.
PubMed 32845247
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aftercare of Childhood Cancer Survivors in Switzerland - the ACCS Switzerland Project
- ClinicalTrials.gov ID
- NCT04284189
- Acronym / sponsor ID
- ACCS / 2018-02304
- Conditions
- Childhood Cancer, Survivorship, Transition
- Keywords
- Childhood Cancer Survivor, Transition of follow-up care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Kantonsspital AarauUniversity, hospital or other
- Collaborators
- University Children's Hospital Basel, Luzerner Kantonsspital
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 25 Feb 2020 (actual)
- 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 Aftercare of Childhood Cancer Survivors in Switzerland (ACCS) study is a multicenter cohort study designed to investigate transition of follow-up care from pediatric oncology to adult care in a prospective and longitudinal way. The investigators collect data on preferences and expectations for follow-up care and transition to adult care by questionnaires in adolescent and young adult survivors of childhood cancer.
Detailed description
Background: Every year over 300 children and adolescents up to the age of 18 years are newly diagnosed with cancer in Switzerland. Survival after childhood cancer has increased substantially over the last decades and 10-year survival now exceeds 85%. This results in an increasing numbers of childhood cancer survivors - currently around 7,000 survivors in Switzerland. Due to cancer treatment or the cancer itself, a large part of the childhood cancer survivors suffers from late effects. Early diagnosis and intervention can reduce morbidity and mortality due to late effects. Therefore, regular follow-up care, even beyond childhood, is very important, but transition from pediatric to adult follow-up care is a critical point. In Switzerland there are very different aftercare and transition models, although it is unclear which aftercare strategy is the best and meets the needs of survivors. The Aftercare of Childhood Cancer Survivors (ACCS) study aims to fill this gap.
Objectives: The main objective of the ACCS study is to identify the current needs of adolescent and young adult long-term survivors in terms of follow-up care by comparing three different transition practices. The secondary objective is to assess survivors' knowledge on their diagnosis, therapy and follow-up examinations longitudinally.
Methods: ACCS is a multicenter questionnaire-based study, including survivors from three pediatric oncology centers in Switzerland. Eligible survivors who already transitioned to adult care at start of the study once receive a letter explaining the purpose of the study, the study information, the informed consent form, and the questionnaire. The questionnaire asks about cancer knowledge and additionally includes validated scales on cancer worry, self-management skills, ongoing care, and expectations. The survivors send the documents back by a prepaid envelope. Eligible survivors before transition to adult care at start of the study receive a letter explaining the purpose of the study, the study information and informed consent form, and the first questionnaire two to four weeks before the next scheduled follow-up visit. They can either send the documents back before the visit or bring them to the visit. The participants receive three month after the visit a short questionnaire to assess cancer knowledge. Three month after the follow-up visit after transition (15 month after last visit in pure pediatric setting), the participants receive the first comprehensive questionnaire again.
Rationale and significance: There are very different aftercare and transition models in Switzerland, although it is unclear which follow-up care strategy best meets the needs of survivors. The data collected within the ACCS study helps to define which transition and follow-up care strategies and related factors are favoured by adolescent and young adult survivors. Adaption of transition processes to the needs of survivors improve adherence to follow-up care of adult childhood cancer survivors. As late effects increase with increasing time from treatment, adult survivors of childhood cancer are at particular risk to develop late effects and it is important that they continue follow-up care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of childhood cancer survivors, who were diagnosed in three Swiss pediatric oncology centers at age <18 years and are ≥5-year from diagnosis and age ≥16 years at study inclusion. Additionally, survivors are at study start in follow-up care at one of the three pediatric oncology centers (group before transition) or have been transitioned to adult care not before 2014 (group after transition)
Key inclusion criteria (6 listed)
- 5-year survivor of childhood cancer
- Diagnosis according to ICCC3 I-XII; Langerhans cell histiocytosis (LCH), Hemophagocytic lymphohistiocytosis (HLH)
- Age at diagnosis <18 years
- Age at study ≥16 years
- At study start in follow-up care at one of the three pediatric oncology centers (group before transition) or transitioned not before 2014 (group after transition).
Key exclusion criteria (5 listed)
- Treatment only by means of surgery and without increased risk of late effects (e.g. teratoma)
- <5 years after therapy of a relapse or palliative situation
- Severe cognitive impairment, which makes it impossible to complete the questionnaire independently
- Insufficient knowledge of the German language
- Informed consent form not signed
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 |
|---|---|---|
| Transition modelTransition of follow-up care of childhood cancer survivors to adult care | Other | – |
Primary outcome
Cancer Worry as part of transition readiness
Time frame: Change from baseline to 3 month and 15 month
Assessment via validated "Cancer Worry Scale"
Self-management as part of transition readiness
Time frame: Change from baseline to 3 month and 15 month
Assessment via validated "Self-Management Skill Scale"
Evaluation of needs for ongoing care as part of transition readiness
Time frame: Change from baseline to 3 month and 15 month
Assessment via validated "Scale for ongoing Care"
Evaluation of expectation for transition as part of transition readiness
Time frame: Change from baseline to 3 month and 15 month
Assessment via validated "Expectation Scale"
1 secondary outcome
Survivors' cancer specific knowledge
Time frame: Change from baseline to 3 month and 15 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Derived from this study: PubMed 39133122Otth M, Kroiss-Benninger S, Scheinemann K. Aftercare of Childhood Cancer Survivors in Switzerland-The General Practitioner Model. J Adolesc Young Adult Oncol. 2025 Feb;14(1):53-61. doi: 10.1089/jayao.2024.0059. Epub 2024 Aug 12.
- Derived from this study: PubMed 32845247Denzler S, Otth M, Scheinemann K. Aftercare of Childhood Cancer Survivors in Switzerland: Protocol for a Prospective Multicenter Observational Study. JMIR Res Protoc. 2020 Aug 26;9(8):e18898. doi: 10.2196/18898.
- Individual participant dataSharing planned: No
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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.
Katrin Scheinemann, MD principal investigator
Kantonsspital Aarau
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Cancer and Survivorship, run by Kantonsspital Aarau at 3 sites in Switzerland.
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 6 inclusion and 5 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 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. 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 Katrin Scheinemann, MD (004162 838 4909, katrin.scheinemann@ksa.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer Worry as part of transition readiness (time frame: Change from baseline to 3 month and 15 month). The study lists 4 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 NCT04284189, which also lists 2 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 17 Aug 2022.