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Swiss Childhood Cancer Survivor Study (SCCSS)

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ClinicalTrials.gov Identifier: NCT03297034
Recruitment Status : Recruiting
First Posted : September 29, 2017
Last Update Posted : October 15, 2018
Sponsor:
Collaborator:
Swiss Pediatric Oncology Group
Information provided by (Responsible Party):
University of Bern

Brief Summary:
The SCCSS is designed to investigate which long-term effects childhood cancer and its treatment have on survivors, and includes those who were under 21 when they were diagnosed. The SCCSS explores childhood cancer survivors' quality of life, the health care received by childhood cancer survivors during follow-up care, the effects of medication, somatic and psychosocial health issues, how childhood cancer survivors take care of their own health, and also collects demographic details like family background, education and profession. To learn more about these topics, the investigators send questionnaires to childhood or adolescent cancer survivors; to date, they have received almost 2900 completed questionnaires. The investigators use the results to inform physicians and patients, and to improve treatment of childhood cancer and follow-up.

Condition or disease
Childhood Cancer

Detailed Description:

Background: Therapies have improved so much in the past decades that more than 80% of children and adolescents now survive cancer. This means that the population of long-term childhood cancer survivors is growing. Since cancer and its treatments may later have adverse effects, it is important to track and improve survivor health and quality of life. Comprehensive data on the burden of late effects of childhood cancer or risk factors for late effects was not available, and so Switzerland set up the SCCSS to increase knowledge and improve the quality of care and follow-up.

Objectives: The SCCSS investigates long-term outcomes of survivors of childhood and adolescent cancer, and the incidence and spectrum of various somatic and psychosocial outcomes including late mortality, second primary malignancies, somatic health and medication, mental health, educational achievements, health-related quality of life, and the association of these outcomes with risk factors like tumor, treatment modalities, and demographic characteristics. The SCCSS also investigates how health-care is provided, and how long-term childhood cancer survivors take care of their health.

Methods: All Swiss residents who were diagnosed with cancer at age <21 years, have survived at least 5 years since cancer diagnosis, received a detailed questionnaire. The investigators added data from general practitioners and hospital records. To compare survivors with the general population, they also send the questionnaire to the siblings of childhood cancer survivors.

Rationale and significance: The data collected by the SCCSS allows the investigators to study long-term outcomes of Swiss childhood cancer survivors. The SCCSS helps to learn more about the incidence of late effects and their risk factors. It also allows to summarize the current state of care in Switzerland. Since early diagnosis can prevent or mitigate many late effects, tracking them will help to improve the health of current and future childhood cancer survivors.

Current status of the project: From 2008-2017, the investigators have contacted 4140 childhood cancer survivors diagnosed between 1976-2010 and 1508 of their siblings. To date, 2876 childhood cancer survivors and 868 siblings returned the questionnaire. The investigators contact new 5-year childhood cancer survivors at regular intervals, and continuously analyse and publish data and findings. In 2017 the investigators have contacted 1579 childhood cancer survivors for a follow-up questionnaire and will continue with this at regular intervals.

Funding: Swiss Cancer League (Grant No KLS-01605-10-2004, KLS-2215-02-2008, KLS-3412-02-2014, KLS-3644-02-2015, and KLS-3886-02-2016), Bernese Cancer League, Cancer League Zurich, Cancer League Aargau, Kinderkrebs Schweiz, European Union (PanCareLIFE; FP7-HEALTH-2013-INNOVATION-1 HEALTH.2013.2.4.1-3, Grant No 602030). The work of the Swiss Childhood Cancer Registry is supported by the Swiss Pediatric Oncology Group (www.spog.ch), Schweizerische Konferenz der kantonalen Gesundheitsdirektorinnen und -direktoren (www.gdk-cds.ch), Swiss Cancer Research (www.krebsforschung.ch), Kinderkrebshilfe Schweiz (www.kinderkrebshilfe.ch), the Federal Office of Public Health (FOPH), and the National Institute of Cancer Epidemiology and Registration (www.nicer.org).


Study Type : Observational [Patient Registry]
Estimated Enrollment : 3626 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 50 Years
Official Title: Swiss Childhood Cancer Survivor Study (SCCSS)
Actual Study Start Date : January 1, 2007
Estimated Primary Completion Date : January 2050
Estimated Study Completion Date : January 2050

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Long-term outcomes of survivors of childhood and adolescent cancer [ Time Frame: Baseline medical information and questionnaire data collection among those who survived at least 5 years, follow-up data collection at regular intervals (+/- every 5 years, 40 years) afterwards. ]
    Incidence and spectrum of various somatic and psychosocial outcomes including describing the cause-specific long-term mortality, the number of patients with second primary malignancies and somatic health effects, and describe medication use, mental health status, educational achievements, and health-related quality of life of childhood cancer survivors as assessed by questionnaires and data from the Swiss Childhood Cancer Registry.


Secondary Outcome Measures :
  1. Risk factors of long-term outcomes of survivors of childhood and adolescent cancer [ Time Frame: Baseline medical information and questionnaire data collection among those who survived at least 5 years, follow-up data collection at regular intervals (+/- every 5 years, 40 years) afterwards. ]
    Association of long-term outcomes with risk factors like tumour, treatment modalities, and demographic characteristics as assessed by questionnaires and data from the Swiss Childhood Cancer Registry.



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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Childhood cancer survivors: All living individuals who were diagnosed with cancer at age <21 years, have survived at least 5 years after cancer diagnosis, and who were Swiss residents when they were diagnosed.

Siblings: brothers and sisters of childhood cancer survivors.

Criteria

Inclusion Criteria:

  • Who were diagnosed with cancer at age <21 years
  • Who have survived at least 5 years after cancer diagnosis
  • Who were Swiss residents when they were diagnosed, and
  • Who gave informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03297034


Contacts
Contact: Claudia E Kuehni, Prof. +41 (0)31 631 35 07 claudia.kuehni@ispm.unibe.ch
Contact: Verena A. Pfeiffer, Dr. +41 (0)31 631 56 70 verena.pfeiffer@ispm.unibe.ch

Locations
Switzerland
Institute of Social and Preventive Medicine (ISPM), University of Bern Recruiting
Bern, Switzerland, 3012
Contact: Claudia E Kuehni, Prof.    +41 (0)31 631 35 07    claudia.kuehni@ispm.unibe.ch   
Contact: Verena A Pfeiffer, Dr.    +41 (0)31 631 56 70    verena.pfeiffer@ispm.unibe.ch   
Sponsors and Collaborators
University of Bern
Swiss Pediatric Oncology Group
Investigators
Study Director: Claudia E Kuehni, Prof. Institute of Social and Preventive Medicine (ISPM), Univeristy of Bern

Additional Information:
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Bern
ClinicalTrials.gov Identifier: NCT03297034     History of Changes
Other Study ID Numbers: SCCSS
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Bern:
Late effects
Childhood cancer survivors
Swiss Childhood Cancer Registry
Europe