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

NCT03945032 | Withdrawn

• 1 other identifier: 1819-30 (Uliège)
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Mobile Application

Keywords

Parent of a childhood cancer survivor; E-platform; TICOP mobile App

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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% \[Visual Analog Scale\]

  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% \[Visual Analog Scale\]

  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.

  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.

  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)

  Baseline

Study Arms (1)

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).

Other: TICOP

Interventions

TICOP OTHER

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).

8 parents of a childhood cancer survivor

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vander Haegen Marie: lead

Study Sites (1)

University of Liège (Unit: Health Psychology)

Liège, 4000, Belgium

Location

Related Publications (3)

• 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.

  PMID: 30427278 BACKGROUND

• 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.

  PMID: 29757114 BACKGROUND

• 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.

  PMID: 26181302 BACKGROUND

Study Officials

• Marie Vander Haegen, Dr.

  University of Liege

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor of Psychology (Ph.D) (Uliège)

Model Details: 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.

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 10, 2019
• Study Start: May 15, 2019
• Primary Completion: November 2, 2022
• Study Completion: May 15, 2025
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)