Op Koers Online for parents in pediatric oncology

Empowering parents in pediatric oncology with an online cognitive-behavioral based group intervention: a randomized controlled trial - Op Koers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25566

Enrollment

Registered

2020-04-28

Start date

2020-10-07

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Oncology

Interventions

The intervention under study is Op Koers Online for parents in pediatric oncology. The main goal of the intervention is to improve psychosocial wellbeing and to prevent psychosocial problems by teachi

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Parents are eligible for the study - if their child was diagnosed before with childhood cancer at the age of 0-18 years; - if their child is within 5 years from diagnosis for childhood cancer (during or after successful treatment) - if their child still lives with his/her parent(s) - if they have access to a laptop/computer with internet connection - when they have provided written informed consent

Exclusion criteria

Exclusion criteria: Parents who meet any of the following criteria are excluded from participation: - parents who are not able to follow a group chat course - parents who are not able to fill out Dutch questionnaires

Design outcomes

Primary

Measure	Time frame
Primary study parameters reflect psychosocial wellbeing, measured with validated standardized questionnaires that are completed online by the parents. Differences between intervention condition and waitlist-control condition in change over time on wellbeing are tested. Questionnaires used for the primary outcomes: - Patient Reported Outcomes Measurement Information System (PROMIS) item banks - anxiety and depression (Computer adaptive testing) - Hospital anxiety and depression scale (HADS) - anxiety and depression - Distress Thermometer for Parents (DT-P) - parental overall distress, thermometer score only - Situation-Specific Emotional Reaction Questionnaire (SSERQ) - Situation-Specific Emotional Reactions - Pediatric Quality Of Life Inventory Family Impact Module (PedsQL FIM) - Family relationships and Worry - Insomnia Severity Index (ISI) – Insomnia	—

Measure

Time frame

Primary study parameters reflect psychosocial wellbeing, measured with validated standardized questionnaires that are completed online by the parents. Differences between intervention condition and waitlist-control condition in change over time on wellbeing are tested. Questionnaires used for the primary outcomes: - Patient Reported Outcomes Measurement Information System (PROMIS) item banks - anxiety and depression (Computer adaptive testing) - Hospital anxiety and depression scale (HADS) - anxiety and depression - Distress Thermometer for Parents (DT-P) - parental overall distress, thermometer score only - Situation-Specific Emotional Reaction Questionnaire (SSERQ) - Situation-Specific Emotional Reactions - Pediatric Quality Of Life Inventory Family Impact Module (PedsQL FIM) - Family relationships and Worry - Insomnia Severity Index (ISI) – Insomnia

—

Secondary

Measure	Time frame
Secondary study parameters reflect coping (online questionnaires) and feasibility (both questionnaires with course leaders and participants, and the recording of logistical and recruitment issues).	—

Contacts

Public ContactMala Joosten

Princess Maxima Centre for pediatric oncology

m.joosten@prinsesmaximacentrum.nl0650006729

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)