Surveys and Questionnaires Clinical Trial
Official title:
The Value of Follow-Up After Childhood Acute Lymphoblastic Leukaemia in Denmark - Family Perspectives
NCT number | NCT03985215 |
Other study ID # | 2016-051-000001 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | December 2020 |
Est. completion date | November 2021 |
Verified date | July 2020 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The aim of the study is to evaluate the family perspective on follow-up programs after treatment for childhood acute lymphoblastic leukaemia. It is relevant when new follow-up programs are to be designed.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 2021 |
Est. primary completion date | July 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 15 Years |
Eligibility |
Inclusion Criteria: - Patients with B-precursor ALL and T-ALL enrolled in the NOPHO ALL-2008 trial - Age group 1.0-14.9 years. - Patients treated on one of the four Danish Paediatric oncology departments - Patients in the time period 0-5 years after cessation of maintenance therapy for ALL Exclusion Criteria: - A history of recurrence or second malignancies - Bone marrow transplantation - Down syndrome - If, due to language barriers, the family is unable to complete the questionnaire. |
Country | Name | City | State |
---|---|---|---|
Denmark | Karen Schow Jensen | Aarhus | Aarhus N |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Degree of parental concern | Self-designed questionnaire. Six items scored on a scale 1-7. Higher values represent a worse outcome. An average is calculated over the six items. An item evaluating the need for extra visits on a scale 1-3. Higher values represent a worse outcome. An item evaluating parental reported worries about the future on a scale 1-5. Higher values represent a worse outcome. |
A single point in time when questionnaires are answered. The specific time point being 0-5 years after end of ALL treatment. | |
Secondary | Satisfaction with the follow-up program | Self-designed questionnaire. An item evaluating satisfaction the time interval between visits on a scale 1-3. Higher values represent a worse outcome. | A single point in time when questionnaires are answered. The specific time point being 0-5 years after end of ALL treatment. | |
Secondary | PedsQL scores | Pediatric Quality of Life Inventory questionnaire (the parent proxy). A validated measure of health-related quality of life. | A single point in time when questionnaires are answered. The specific time point being 0-5 years after end of ALL treatment. | |
Secondary | The amount of self-reported side effects | Self-designed questionnaire. Fifteen items scored on a scale 1-7. Higher values represent a worse outcome. An average is calculated over the fifteen items. An item evaluating the duration of the time period before the child was able to attend day-care/school on a scale 1-5. Higher values represent a worse outcome. |
A single point in time when questionnaires are answered. The specific time point being 0-5 years after end of ALL treatment. | |
Secondary | Strategy of the families between follow-up visits | Self-designed questionnaire. In need of advice between visits what are the strategy of the participants: seeking hospital, general practitioner or postponing till next scheduled visit. | A single point in time when questionnaires are answered. The specific time point being 0-5 years after end of ALL treatment. |
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