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

NCT ID: NCT03945032

Last Updated: 2023-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-15

Study Completion Date

2025-05-15

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Mobile Application

Keywords

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Parent of a childhood cancer survivor E-platform TICOP mobile App

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

8 parents of a childhood cancer survivor will participate in this study (baseline + three times per year). Parents will answer on the TICOP mobile app. Parents will pretest the "TICOP" mobile app. One year later, they will return to the laboratory in order to brainstorm with the principal investigator (an accredited psychologist) about the mobile App and its operation and usefulness.
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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8 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).

Group Type EXPERIMENTAL

TICOP

Intervention Type OTHER

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).

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vander Haegen Marie

OTHER

Sponsor Role lead

Responsible Party

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Vander Haegen Marie

Doctor of Psychology (Ph.D) (Uliège)

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Marie Vander Haegen, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Liege

Locations

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University of Liège (Unit: Health Psychology)

Liège, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type BACKGROUND
PMID: 30427278 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29757114 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26181302 (View on PubMed)

Other Identifiers

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1819-30 (Uliège)

Identifier Type: -

Identifier Source: org_study_id