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

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ClinicalTrials.gov Identifier: NCT03945032
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Vander Haegen Marie, University of Liege

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 Intervention/treatment Phase
Mobile Application Other: TICOP Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
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 15, 2019
Estimated Primary Completion Date : May 15, 2020
Estimated Study Completion Date : May 15, 2024

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. Psychological symptoms [ 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 [ 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 [ 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 [ 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 [ 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 [ 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) [ Time Frame: Baseline ]
    14 items (multiple-choice response)



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03945032


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

Locations
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Belgium
University of Liège (Unit: Health Psychology) Recruiting
Liège, Belgium, 4000
Contact: Marie Vander Haegen, Dr.    +32 4 366 32 64    mvanderhaegen@uliege.be   
Principal Investigator: Marie Vander Haegen, Dr.         
Sponsors and Collaborators
Vander Haegen Marie
Investigators
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Principal Investigator: Marie Vander Haegen, Dr. University of Liège

Publications:
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Responsible Party: Vander Haegen Marie, Doctor of Psychology (Ph.D) (Uliège), University of Liege
ClinicalTrials.gov Identifier: NCT03945032     History of Changes
Other Study ID Numbers: 1819-30 (Uliège)
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vander Haegen Marie, University of Liege:
Parent of a childhood cancer survivor
E-platform
TICOP mobile App