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出境医 / 临床实验 / TICOP Mobile App and E-platform: Providing Information and Support for Parents Caring for Their Child Cancer Survivor (TICOP)

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

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 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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: N/A
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, 2021
Estimated Study Completion Date : May 15, 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
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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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Marie Vander Haegen, Dr. +32 4 366 32 64 mvanderhaegen@uliege.be

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Marie Vander Haegen, Dr. University of Liege
Tracking Information
First Submitted Date  ICMJE May 3, 2019
First Posted Date  ICMJE May 10, 2019
Last Update Posted Date September 25, 2020
Actual Study Start Date  ICMJE May 15, 2019
Estimated Primary Completion Date May 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2020)
  • 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.
  • 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.
  • 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]
  • 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]
  • 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.
  • 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.
  • Sociodemographic questionnaire (parents of a childhood cancer survivor) (created for the needs of the study) [ Time Frame: Baseline ]
    14 items (multiple-choice response)
Original Primary Outcome Measures  ICMJE
 (submitted: May 7, 2019)
  • 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
    • item 1: tense
    • item 2: isolated
    • item 3: worried in general
    • item 4: worried about the evolution of my child's health
    • item 5: tired
    • item 6: depressed
    • item 7: nervous
    • item 8: in a bad mood
    • item 9: slow thinking
    • item 10: hypervigilant
    • item 11: amorphous
    • item 12: sad
    • item 13: anxious
    Note. Results are significant when the score is above 25% for one single item with at least two occurrences over time period.
  • 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
    • item 1: insomnia at the beginning of the night
    • item 2: insomnia in the middle of the night
    • item 3: insomnia at the end of the night
    • item 4: loss of energy
    • item 5: weight loss or gain
    • item 6: gastro-intestinal problems
    • item 7: headaches
    • item 8: backaches
    • item 9: muscle tension
    • item 10: high blood pressure
    • item 11: dizziness
    • item 12: heart palpitations
    • item 13: dry mouth
    • item 14: nausea
    • item 15: sense of shortness of breath or suffocation
    • item 16: sexual disorder or difficulties
    Note. Results are significant when the score is above 25% for one single item with at least two occurrences over time period.
  • 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]
    • item 1: family support
    • item 2: social support
    • item 3: medical support
    • item 4: active listening from the family
    • item 5: active listening from friends
    • item 6: active listening from the medical team (e.g.oncologist, psychologist)
    • item 7: information from the medical team (e.g.oncologist, psychologist)
    • item 8: psychological support (and intervention) with a professional
    • item 9: psychological support via a support group
  • 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]
    • item 1: family emotional support
    • item 2: emotional support from friends
    • item 3: emotional support from the medical team (e.g.oncologist, psychologist)
    • item 4: communication and dialogue with the family
    • item 5: communication and dialogue with friends
    • item 6: communication and dialogue with the medical team (e.g.oncologist, psychologist)
    • item 7: information from the the medical team (e.g.oncologist, psychologist)
    • item 8: psychological support (and intervention) with a professional
  • 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]
    • item 1: tense-anxious
    • item 2: managing the uncertainty - don't managing the uncertainty
    • item 3: agreeable - hostile
    • item 4: thoughtful - impulsive
    • item 5: dealing with feelings or emotions - don't dealing with feelings or emotions
    Note. Results are significant when the score is above 25% for one single item with at least two occurrences over time period.
  • 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]
    • item 1: optimistic-pessimistic
    • item 2: outgoing-introvert
    • item 3: persistent - few persistent
    • item 4: conscientious - few conscientious
    • item 5: self confident - few self confident
    • item 6: emotionally stable - few emotionally stable
    Note. Results are significant when the score is above 25% for one single item with at least two occurrences over time period.
  • Sociodemographic questionnaire (parents of a childhood cancer survivor) [ Time Frame: Baseline ]
    14 items (multiple-choice response)
    • item 1: gender
    • item 2: civil status
    • item 3: education level
    • item 4: work situation
    • item 5: child cancer survivor gender
    • item 6: child cancer survivor age
    • item 7: remission time
    • item 8: diagnosis of cancer
    • item 9: treatments
    • item 10: treatment time
    • item 11: treatments side effects
    • item 12: relapse
    • item 13: medications taken during the treatment of cancer of the child
    • item 14: medications taken during the cancer remission of the child
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TICOP Mobile App and E-platform: Providing Information and Support for Parents Caring for Their Child Cancer Survivor
Official Title  ICMJE Digital Technology for Parents in Pediatric Oncology: Development and Implementation
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
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
Condition  ICMJE Mobile Application
Intervention  ICMJE 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).
Study Arms  ICMJE 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).
Intervention: Other: TICOP
Publications *
  • 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.
  • 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.
  • 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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 7, 2019)
8
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 15, 2024
Estimated Primary Completion Date May 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Marie Vander Haegen, Dr. +32 4 366 32 64 mvanderhaegen@uliege.be
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03945032
Other Study ID Numbers  ICMJE 1819-30 (Uliège)
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Vander Haegen Marie, University of Liege
Study Sponsor  ICMJE Vander Haegen Marie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marie Vander Haegen, Dr. University of Liege
PRS Account University of Liege
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP