TICOP Mobile App and E-platform: Providing Information and Support for Parents Caring for Their Child Cancer Survivor

Mobile Application Clinical Trial

— TICOP  

Official title:

Digital Technology for Parents in Pediatric Oncology: Development and Implementation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03945032
• Other study ID #: 1819-30 (Uliège)
• Status: Withdrawn
• Phase: N/A
• Start date: May 15, 2019
• Est. completion date: May 15, 2025

Study information

• Verified date: December 2023
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Parents of a childhood cancer survivor face ongoing social, and psychological challenges that may result in enduring illness and caregiving related distress and vulnerabilities. It has been described namely: post posttraumatic stress symptoms [PTSS], lingering worries, anxiety and depression. While strategies and interventions to minimize the child's distress have become part of comprehensive medical care in paediatrics, it also becomes urgent to develop research into parents of a childhood cancer survivor in order to: [1] train the medical staff to identify the serious issue of parental distress ; [2] detect other markers of vulnerabilities (e.g. pessimism, anxiety trait) and [3] provide them with a personalized psychological intervention. This would allow vigilance of the medical staff in detecting parents' distress and could defuse their descent into a vicious circle of psychosocial difficulties. Up to now, empirical findings suggest the importance to develop a screening tool for parents of a CCS in order to detect any parent who presents several difficulties and to propose personal intervention. To the investigator's knowledge, there is no tool to detect and prevent psychological distress among parents of a childhood cancer survivor. The TICOP mobile app consists of seven axis of evaluation and detection for parents of a childhood cancer survivor: Parent moves the cursor by analogy on their mobile phone (as a visual anagogic scale) four times per year (baseline; month 4; month 8 and month 12). Axis 1: sociodemographic (e.g. gender, marital status) (14 items) Axis 2: psychosomatic symptoms (insomnia, migraine) (16 items) Axis 3: psychological symptoms (e.g. depression, anxiety) (13 items) Axis 4: parental needs (e.g. social support, information) (9 items) Axis 5: parental resources (e.g. emotional support) (8 items) Axis 6: parental risk factors (e.g. anxiety, intolerant of uncertainty) (5 items) Axis 7: parental protective factors (e.g. optimistic,extraverted) (6 items) All information will be automatically sent in real time into the E-platform. This digital tool allows to obtain a parental state follow-up for the health professional (e.g. oncologist, psycho-oncologist).

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Mobile Application

Intervention

Other:
• TICOP
Parent moves the cursor by analogy on their mobile phone (as a visual anagogic scale) four times per year (baseline; month 4; month 8 and month 12).

Locations

Country	Name	City	State
Belgium	University of Liège (Unit: Health Psychology)	Liège

Sponsors (1)

Lead Sponsor	Collaborator
Vander Haegen Marie

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

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

Outcome

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