Mobile ApplicationTICOPNCT03945032
TICOP Mobile App and E-platform: Providing Information and Support for Parents Caring for Their Child Cancer Survivor
A study testing TICOP in people with Mobile Application, run by Vander Haegen Marie at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mobile Application
- What is being tested?
- TICOP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- 15 May 2019to 15 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Mobile Application
- Being tested
- TICOP
- Keywords
- Parent of a childhood cancer survivor, E-platform, TICOP mobile App
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TICOPOther
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 group | Role | What they receive |
|---|---|---|
| 8 parents of a childhood cancer survivor | Experimental | 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). Receives: Other: TICOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological symptoms (created for the needs of the study)
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.
Measured: 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)
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.
Measured: 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)
9 items ranged between 0% at 100% [Visual Analog Scale]
Measured: 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)
8 items ranged between 0% at 100% [Visual Analog Scale]
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
14 items (multiple-choice response)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start15 May 2019
- Primary completion2 Nov 2022
- Study completion15 May 2025 (estimated)
Why it stopped: In process (technical improvements)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mobile ApplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vander Haegen Marie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vander Haegen Marie, University of Liege
- Investigators
- Marie Vander Haegen, Dr., Principal investigator, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945032
- Sponsor's protocol ID
- 1819-30 (Uliège)
- Acronym
- TICOP
- Status last verified
- Dec 2023
- First submitted
- 3 May 2019
- Last updated
- 11 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30427278Vander 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.
PubMed 29757114Vander 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.
PubMed 26181302
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Technology for Parents in Pediatric Oncology: Development and Implementation
- ClinicalTrials.gov ID
- NCT03945032
- Acronym / sponsor ID
- TICOP / 1819-30 (Uliège)
- Conditions
- Mobile Application
- Keywords
- Parent of a childhood cancer survivor, E-platform, TICOP mobile App
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: In process (technical improvements)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vander Haegen MarieUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 2 Nov 2022 (actual)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| 8 parents of a childhood cancer survivor | Experimental | Other: TICOPParent 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TICOPParent 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 | 8 parents of a childhood cancer survivor |
Primary outcome
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Background: PubMed 30427278Vander 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.
- Background: PubMed 29757114Vander 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.
- Background: PubMed 26181302Vander 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Vander Haegen, Dr. principal investigator
University of Liege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TICOP in people with Mobile Application, run by Vander Haegen Marie at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03945032, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023; AzTrials last refreshed its copy on 27 Oct 2026.