Supportive Care Needs of Former Child, AYA Cancer Patients, and of Their Parents: Evaluation During Long-term Follow-up
ExPEDAJAC
1 other identifier
observational
99
1 country
1
Brief Summary
Each year, there are 2100 new cases of cancer in children and adolescents/young adults (AYA) in France. Due to a significant improvement in the effectiveness of therapies, the survival rate of all types of cancer combined after 5 years is 80-85%. This is leading to the emergence of new problems, which require an adaptation of the long-term care of these former patients. Nevertheless, although some medical complications have been widely described and are the subject of recommendations, many questions remain unanswered regarding the real long-term needs of patients and of their main caregivers. The main objective of this study is to assess not only the specific supportive care needs of former onco-hematology patients treated before the age of 25 years, but also those of their parents up to 6 months after the end of the oncological follow-up, i.e. 3 to 5 years after the diagnosis. The secondary objectives aim to:
- 1.Assess adherence to long-term follow-up medical consultation
- 2.Assess the early complications presented by the patients
- 3.Assess the quality of life and the anxiety-depression of former patients and their parents
- 4.Describe and evaluate the offer and use of the network of health professionals aware of the post-treatment issues; assess the referral to the network of health professionals aware of the post-treatment issues.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2021
CompletedFirst Posted
Study publicly available on registry
January 15, 2021
CompletedStudy Start
First participant enrolled
February 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 18, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2023
CompletedMarch 5, 2025
March 1, 2025
1.9 years
January 11, 2021
March 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Qualitative interview
To identify the supportive care needs of patients and parents as well as their expectations with regard to a long-term follow-up
From 1 to 6 months after the standard monitoring consultation
Secondary Outcomes (5)
Quantitative measures to assess adherence to long-term follow-up medical consultation
From 1 to 6 months after the standard monitoring consultation
Clinical Case Report Form to assess the early complications presented by the patients
From 1 to 6 months after the standard monitoring consultation
Scores of quality of life
From 1 to 6 months after the standard monitoring consultation
Scores of anxiety-depression
From 1 to 6 months after the standard monitoring consultation
Quantitative measures to describe and evaluate the offer and use of the network of health professionals who are aware of post-treatment issues
One year after the long-term follow-up consultation
Study Arms (6)
Patients 6-14 years old
Individual interview + Self-report questionnaire + long-term follow-up medical consultation + At 1 year : Assessment of prescription's adherence
Parents of 6-14 years old patients
Individual interview + Self-report questionnaire
Patients 15-25 years old
Individual interview + Self-report questionnaire + long-term follow-up medical consultation + At 1 year : Assessment of prescription's adherence
Parents of 15-25 years old patients
Individual interview + Self-report questionnaire
Patients > 25 years old
Individual interview + Self-report questionnaire + long-term follow-up medical consultation + At 1 year : Assessment of prescription's adherence
Parents of > 25 years old patients
Individual interview + Self-report questionnaire
Interventions
The qualitative interview aims to identify the supportive care needs of patients and parents as well as their expectations with regard to a long-term follow-up.
To assess the quality of life, anxiety/depression of former patients and relatives: For child and adolescent patients (less than 15 years old at inclusion): * Pediatric Quality of Life Inventory Cancer module * Screen for Child Anxiety Related Emotional Disorders Revised * Children's Depression Inventory For patients over 15 years of age at the time of inclusion and parents: * 36-Item Short Form Health Survey * Hospital Anxiety and Depression Scale To describe and evaluate the offer and use of the network of health professionals who are aware of post-treatment issues: number of consultations, speciality and location of the professionals requested following the long-term follow-up consultation, time between referral and first consultation, evaluation of the geographical accessibility of care around the patient's home.
To assess adherence to long-term follow-up medical consultation: \- number of patients summoned/ number of consultations carried out ; reason for refusal of long-term follow-up medical consultation To assess medical complications through clinical data collection
Eligibility Criteria
The study will be proposed systematically to all former patients of the hospital department diagnosed before the age of 25 years and at least 6 years of age at the time of inclusion as well as to their parents. The experiences and the specific needs of each person (patients, mothers and fathers) will be assessed independently. Three independent groups will be formed based on the age of the patient when included in the study. For each group, the parents may or may not be paired with the patients. A sample of 60 former pediatric patients (20 per age group) and 60-120 parents (ideally 40 per age group) is expected. This is the number of interviews after which data saturation generally occurs, i.e. no emergence of new themes from one interview to another.
You may qualify if:
- Patient, or the parent of a patient, previously treated at Institut d'Hématologie et d'Oncologie Pédiatrique /Leon Berard comprehensive cancer centre
- Patient treated for a solid tumor or a lymphoma
- Patient in complete response and having finished his/her standard oncological monitoring between 1 and 6 months ago i.e. 3 to 5 years after the diagnosis
- Patients and parents capable of understanding, reading and writing French
- Patient affiliated to a health insurance plan
- Having been informed of the study and not objecting to it
You may not qualify if:
- Cannot be followed-up for medical, social, familial, geographical or psychological reasons, throughout the duration of the study
- Deprived of liberty by a court or administrative decision
- Person who refused to participate or was incapable of objecting in an informed manner
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Leon Berardlead
- University of Paris 5 - Rene Descartescollaborator
- Institut d'Hématologie et d'Oncologie Pédiatriquecollaborator
Study Sites (1)
Centre Léon Bérard - Institut d'Hémato-Oncologie Pediatrique
Lyon, 69373, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2021
First Posted
January 15, 2021
Study Start
February 11, 2021
Primary Completion
January 18, 2023
Study Completion
February 15, 2023
Last Updated
March 5, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share