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

December 8, 2023 updated by: Vander Haegen Marie

Digital Technology for Parents in Pediatric Oncology: Development and Implementation

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Liège, Belgium, 4000
        • University of Liège (Unit: Health Psychology)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological symptoms (created for the needs of the study)
Time Frame: Measure assessing change between four time points (change from Baseline at 4 months, 8 months and 12 months)

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)
Psychosomatic symptoms (created for the needs of the study)
Time Frame: Measure assessing change between four time points (change from Baseline at 4 months, 8 months and 12 months)

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)
Parental needs (created for the needs of the study)
Time Frame: Measure assessing change between four time points (change from Baseline at 4 months, 8 months and 12 months)
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)
Parental resources (created for the needs of the study)
Time Frame: Measure assessing change between four time points (change from Baseline at 4 months, 8 months and 12 months)
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)
Parental risk factors (created for the needs of the study)
Time Frame: Measure assessing change between four time points (change from Baseline at 4 months, 8 months and 12 months)

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)
Parental protective factors (created for the needs of the study)
Time Frame: Measure assessing change between four time points (change from Baseline at 4 months, 8 months and 12 months)

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)
Sociodemographic questionnaire (parents of a childhood cancer survivor) (created for the needs of the study)
Time Frame: Baseline
14 items (multiple-choice response)
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vander Haegen Marie

Investigators

  • Principal Investigator: Marie Vander Haegen, Dr., University of Liège

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2019

Primary Completion (Actual)

November 2, 2022

Study Completion (Estimated)

May 15, 2025

Study Registration Dates

First Submitted

May 3, 2019

First Submitted That Met QC Criteria

May 7, 2019

First Posted (Actual)

May 10, 2019

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 8, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1819-30 (Uliège)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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