Mobile Application Clinical Trial
— TICOPOfficial title:
Digital Technology for Parents in Pediatric Oncology: Development and Implementation
Verified date | December 2023 |
Source | University of Liege |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to develop a mobile App (named "TICOP") for parents of a childhood cancer survivor and an E-Platform for health professionals which work in pediatric oncology area. The core objective is to evaluate the effects of these two digital tools (mobile app and platform) in the detection and prevention among parents of a childhood cancer survivor.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 15, 2025 |
Est. primary completion date | November 2, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Parent of a childhood cancer survivor (mother and father) - Child who had been diagnosed in remission since 1 years until 10 years (without relapse) - Neoadjuvant chemotherapy during treatments - Fluency in French speaking - No previous evidence of mental illness. Exclusion Criteria: - Diagnosis of cancer treated only by surgery or radiotherapy (with no adjuvant chemotherapy) - Benign tumor - Child has a relapse or died - Non-French-speaking parents - previous evidence of mental illness. |
Country | Name | City | State |
---|---|---|---|
Belgium | University of Liège (Unit: Health Psychology) | Liège |
Lead Sponsor | Collaborator |
---|---|
Vander Haegen Marie |
Belgium,
Vander Haegen M, Etienne AM. Intolerance of uncertainty as the vulnerability factor among parents of childhood cancer survivors: A 3-month follow-up study. J Psychosoc Oncol. 2018 Jul-Aug;36(4):437-453. doi: 10.1080/07347332.2018.1443192. Epub 2018 May 14. — View Citation
Vander Haegen M, Etienne AM. Intolerance of uncertainty in parents of childhood cancer survivors: A clinical profile analysis. J Psychosoc Oncol. 2018 Nov-Dec;36(6):717-733. doi: 10.1080/07347332.2018.1499692. Epub 2018 Nov 14. — View Citation
Vander Haegen M, Luminet O. Stress, Psychosocial Mediators, and Cognitive Mediators in Parents of Child Cancer Patients and Cancer Survivors: Attention and Working Memory Pathway Perspectives. J Psychosoc Oncol. 2015;33(5):504-50. doi: 10.1080/07347332.2015.1067279. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Psychological symptoms (created for the needs of the study) | 13 items ranged between 0% at 100% [Visual Analog Scale] Scale range : 0 = rarely; 1 = occasionally ; 2 = often; 3 = mostly
Note. Results are significant when the score is above 25% for one single item with at least two occurrences over time period. |
Measure assessing change between four time points (change from Baseline at 4 months, 8 months and 12 months) | |
Primary | Psychosomatic symptoms (created for the needs of the study) | 16 items ranged between 0% at 100% [Visual Analog Scale] Scale range : 0 = rarely; 1 = occasionally ; 2 = often; 3 = mostly
Note. Results are significant when the score is above 25% for one single item with at least two occurrences over time period. |
Measure assessing change between four time points (change from Baseline at 4 months, 8 months and 12 months) | |
Primary | Parental needs (created for the needs of the study) | 9 items ranged between 0% at 100% [Visual Analog Scale] | Measure assessing change between four time points (change from Baseline at 4 months, 8 months and 12 months) | |
Primary | Parental resources (created for the needs of the study) | 8 items ranged between 0% at 100% [Visual Analog Scale] | Measure assessing change between four time points (change from Baseline at 4 months, 8 months and 12 months) | |
Primary | Parental risk factors (created for the needs of the study) | 5 paired-items ranged between 0% at 100% [Visual Analog Scale]
Note. Results are significant when the score is above 25% for one single item with at least two occurrences over time period. |
Measure assessing change between four time points (change from Baseline at 4 months, 8 months and 12 months) | |
Primary | Parental protective factors (created for the needs of the study) | 6 paired-items ranged between 0% at 100% [Visual Analog Scale]
Note. Results are significant when the score is above 25% for one single item with at least two occurrences over time period. |
Measure assessing change between four time points (change from Baseline at 4 months, 8 months and 12 months) | |
Primary | Sociodemographic questionnaire (parents of a childhood cancer survivor) (created for the needs of the study) | 14 items (multiple-choice response) | Baseline |
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