- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04284189
Aftercare of Childhood Cancer Survivors in Switzerland (ACCS)
Aftercare of Childhood Cancer Survivors in Switzerland - the ACCS Switzerland Project
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Katrin Scheinemann, MD
- Phone Number: 004162 838 4909
- Email: katrin.scheinemann@ksa.ch
Study Locations
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-
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Aarau, Switzerland
- Recruiting
- Division of Oncology - Hematology, Department of Pediatrics, Kantonsspital Aarau
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Contact:
- Katrin Scheinemann, MD
-
Principal Investigator:
- Katrin Scheinemann, MD
-
Sub-Investigator:
- Maria Otth, MD
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Sub-Investigator:
- Sibylle Denzler, MD
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Basel, Switzerland
- Recruiting
- Division of Oncology/ Hematology, University Children's Hospital Basel
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Contact:
- Tamara Diesch, MD
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Principal Investigator:
- Tamara Diesch, MD
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Lucerne, Switzerland
- Recruiting
- Division of Oncology/ Hematology, Department of Pediatrics, Kantonsspital Lucerne
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Contact:
- Bernhard Eisenreich, MD
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Principal Investigator:
- Bernhard Eisenreich, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cancer Worry as part of transition readiness
Time Frame: Change from baseline to 3 month and 15 month
|
Assessment via validated "Cancer Worry Scale"
|
Change from baseline to 3 month and 15 month
|
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"
|
Change from baseline to 3 month and 15 month
|
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"
|
Change from baseline to 3 month and 15 month
|
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"
|
Change from baseline to 3 month and 15 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survivors' cancer specific knowledge
Time Frame: Change from baseline to 3 month and 15 month
|
Assessment via questionnaire
|
Change from baseline to 3 month and 15 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Katrin Scheinemann, MD, Kantonsspital Aarau
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2018-02304
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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