Condition category
Cancer
Date applied
22/05/2014
Date assigned
27/06/2014
Last edited
27/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Advances in the diagnosis and treatment of childhood cancer in the last decade has meant that many more children now survive the disease. Unfortunately, however, it has become increasingly apparent that both the treatment and the cancer itself can have long-term effects on health. Long-term follow-up of childhood cancer survivors (CCS) is therefore vital. The Dutch Childhood Oncology Group (DCOG) has set up a nationwide study called DCOG-LATER, which aims to identify which groups of CCS are most at risk of long-term health problems which will then form the basis of recommendations on later follow-up programmes. The study also involves research on accurate screening tests and effective treatments (interventions) that might be needed to reduce morbidity and mortality in CCS. In order for the DCOG-LATER study results to be meaningful, it is important that a representative group of CCS participate in the study. It is therefore vital to encourage as many CCS to participate as possible. Characteristics such as the age and gender of a potential participant and also what the study involves can influence whether or not they will agree to take part. The aim of this study is to investigate the effect of different invitation strategies on participation rates in a questionnaire survey among CCS. We also want to investigate reasons for non-participation, whether people prefer to complete a paper-based or web-based questionnaire and which groups of CCS (in terms of age, or gender) prefer each type of questionnaire.

Who can participate?
Adult CCS that were diagnosed with cancer before the age of 18 and between 1st January 1962 and 31st December 2001, alive 5 years after diagnosis and treated in one of the seven Dutch paediatric oncology and stem cell transplant centers. They also have to be currently living in the Netherlands.

What does the study involve?
Each participant is randomly allocated to one of three groups. All participants receive an initial invitation to take part in the study. For groups 1 and 2, two postal reminders and one telephone reminder are sent out. For group 3, only one postal reminder and one telephone reminder is sent. With each invitation, the CCS were given a web-based questionnaire. Paper-based questionnaires are also given at various timepoints depending on group. Group 3 receive the paper-based questionnaire as part of their initial invitation, group 2 as part of the first reminder and group 1 receive their paper-based questionnaire as part of their second reminder.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Academic Medical Center (Netherlands)

When is the study starting and how long is it expected to run for?
December 2012 to June 2013

Who is funding the study?
The Dutch Childhood Oncology Group (DCOG) (Netherlands)
The Children Cancerfree Foundation (KiKa) (Netherlands)

Who is the main contact?
Miss Monique Jaspers
Academic Medical Center
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Trial website

http://www.skionlaterstudie.nl

Contact information

Type

Scientific

Primary contact

Miss Monique Jaspers

ORCID ID

Contact details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

131

Study information

Scientific title

An evaluation of response rates, questionnaire mode preferences and satisfaction of Dutch childhood cancer survivors invited for the DCOG LATER study

Acronym

Dutch Childhood Oncology Group (DCOG) LATe Effects Registry (LATER) EPIdemiology (EPI)

Study hypothesis

The aim of the current study was to investigate the effect of different invitation strategies on participation rates in a questionnaire survey among childhood cancer survivors (CCS). In addition, we assessed reasons for non-participation, differences in participants’ questionnaire mode preferences and satisfaction with the different questionnaire modes.  

Ethics approval

Medisch Ethisch Toetsingscommissie AMC, 27/04/2012, ref: W12_105

Study design

Multi-center randomized trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Childhood cancer survivors

Intervention

CCS from three centers were randomly allocated to one of three study arms on a 1:1:1 ratio. In study arms 1 and 2, two postal reminders and one telephone reminder followed the initial invitation; in the second reminder strategy (study arm 3), only one postal reminder and one telephone reminder followed the initial invitation. With every invitation, CCS received a web-based questionnaire. Paper-based questionnaires were added to the invitation at various time points depending on the study arm. CCS either received the paper-based questionnaire at the initial invitation (study arm 3), first reminder (study arm 2) or second reminder (study arm 1).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Participation rates assessed 1 year after the start of the study on 01/09/2013

Secondary outcome measures

1. Response rates assessed 1 year after the start of the study on 01/09/2013
2. Response type assessed 1 year after the start of the study on 01/09/2013
3. Satisfaction with questionnaire
4. Reasons for completing paper- or web-based questionnaire

Overall trial start date

01/12/2012

Overall trial end date

01/06/2013

Reason abandoned

Eligibility

Participant inclusion criteria

We randomly selected 750 adult CCS from the DCOG LATER cohort, which includes subjects diagnosed with a malignancy (or a few specific benign disorders) before the age of 18 years between 1 January 1962 and 31 December 2001, alive 5 years post diagnosis, that were treated in one of the seven Dutch paediatric oncology and stem cell transplant centers. For the current study, CCS had to be alive, aged 18 or older and living in the Netherlands.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

750

Participant exclusion criteria

CCS were excluded if they lived abroad or were lost-to-follow-up

Recruitment start date

01/12/2012

Recruitment end date

01/06/2013

Locations

Countries of recruitment

Netherlands

Trial participating centre

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Center (AMC) (Netherlands)

Sponsor details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor type

Hospital/treatment centre

Website

https://www.amc.nl

Funders

Funder type

Charity

Funder name

The Dutch Childhood Oncology Group (DCOG) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Children Cancerfree Foundation (KiKa) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes