The Value of Follow-Up After Childhood Acute Lymphoblastic Leukaemia in Denmark - Family Perspectives

NCT03985215 | Withdrawn DMC

• 1 other identifier: 2016-051-000001
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Surveys and Questionnaires

Keywords

Aftercare

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Satisfaction with the follow-up program

  A single point in time when questionnaires are answered. The specific time point being 0-5 years after end of ALL treatment.

• PedsQL scores

  A single point in time when questionnaires are answered. The specific time point being 0-5 years after end of ALL treatment.

• The amount of self-reported side effects

  A single point in time when questionnaires are answered. The specific time point being 0-5 years after end of ALL treatment.

• Strategy of the families between follow-up visits

  A single point in time when questionnaires are answered. The specific time point being 0-5 years after end of ALL treatment.

Interventions

Questionnaires OTHER

Pediatric Quality of Life Inventory questionnaire. Self-designed questionnaire.

Eligibility Criteria

• Age: 1 Year - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Questionnaires will be sent to all the possible families in Denmark with a child in the period of 0-5 years after cessation of maintenance therapy for ALL.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Karen Schow Jensen

Aarhus, Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Karen S Jensen, MD

  Aarhus Universitet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 13, 2019
• Study Start: December 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: November 1, 2021
• Last Updated: September 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)