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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/20/2021.

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

Clinicaltrials.gov identifier NCT03945032

Recruitment Status Recruiting

First Posted May 10, 2019

Last update posted September 25, 2020

Study Description

Brief 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.

  • Condition or Disease:Mobile Application
  • Intervention/Treatment: Other: TICOP
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Estimated Enrollment: 8 participants
  • Intervention Model: Single Group Assignment
  • Intervention Model Description: 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.
  • Masking: None (Open Label) ()
  • Primary Purpose: Screening
  • Official Title: Digital Technology for Parents in Pediatric Oncology: Development and Implementation
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: May 2021
  • Estimated Study Completion Date: May 2024
Arms and interventions
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).
Outcome Measures
  • Primary Outcome Measures: 1. 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.
  • 2. 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.
  • 3. 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]
  • 4. 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]
  • 5. 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.
  • 6. 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.
  • 7. Sociodemographic questionnaire (parents of a childhood cancer survivor) (created for the needs of the study) [ Time Frame: Baseline ]
    14 items (multiple-choice response)
Eligibility Criteria
  • Ages Eligible for Study: (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

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.

Contacts and Locations
Contacts

Contact: Marie Vander Haegen, Dr. +32 4 366 32 64 mvanderhaegen@uliege.be

Locations

Belgium
University of Liège (Unit: Health Psychology)
Liège

Sponsors and Collaborators

Vander Haegen Marie

Investigators

Principal Investigator: Marie Vander Haegen, Dr. University of Liege