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Recruiting NCT06651242

Decision Support Intervention of Minor Cancer Patients and Their Parents

No phase Interventional Pediatric Cancer Adolescent Health Decision Aids Parents of Children With Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Decision-making information aids, Routine care.
Who it may be relevant to
Registry conditions: Pediatric Cancer, Adolescent Health, Decision Aids, Parents of Children With Cancer. Basic parameters: 7 years — 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effectiveness Evaluation on the Decision Preferences and Decision Support Intervention of Minor Cancer Patients and Their Parents

Overview

The purpose of this stuidy are: (1) to explore the information needs of parents having children with cancer when making treatment decisions; (2) to develop a Taiwan version of the Control Preferences Scale for decision support aids; (3) to implement and evaluate the effectiveness of involving minor cancer patients and their parents in treatment decision-making.

Interventions

  • Other Decision-making information aids
    Provide a decision-making information aids to assist patients and their parents in treatment decision making.
  • Other Routine care
    Routine care

Primary outcome measures

  • Exploring decision-making preferences among parents and minor using the Control Preferences Scale (CPS) [Time frame: baseline and 1.3.6 months]
  • Exploring the perceived involvement in decision-making among parents and minor using the Perceived Involvement in Care Scale (PICS) [Time frame: baseline and 1.3.6 months]
  • Exploring decision-making experiences of parents and minor using the Decision Conflict Scale (DCS) [Time frame: baseline and 1.3.6 months]
  • Exploring perceived family adaptability and cohesion among parents and minor using the Family Adaptability and Cohesion Evaluation Scales IV (FACES IV) [Time frame: baseline and 1.3.6 months]
  • Exploring minor' coping behaviors in response to illness and treatment using the Paediatric Cancer Coping Scale [Time frame: baseline and 1.3.6 months]
  • Exploring minor' anxiety levels using the Revised Children's Manifest Anxiety Scale-2 (RCMAS-2) [Time frame: baseline and 1.3.6 months]
  • Exploring parental anxiety under different characteristics using the State-trait anxiety inventory (STAT) [Time frame: baseline and 1.3.6 months]

Eligibility criteria

Inclusion criteria

  • Inclusion Criteria for Parents:
  • Age over 20 years.
  • Child under 20 years old, diagnosed with cancer by a doctor.
  • their child know her/his cancer diagnosis.
  • Agree to have the child participate in family meeting and have ability to communicate in Mandarin or Taiwanese.
  • Inclusion Criteria for Minors:
  • Aged between 7 and 20 years, diagnosed with pediatrtic cancer.
  • Aware of their cancer diagnosis.
  • Able to express their thoughts to the researcher in Mandarin or Taiwanese.
  • Both the minor and their legal guardian consent to participate in the study.

Exclusion criteria

  • Diagnosed with depression, and/or anxiety, and/or other mental disorders.
  • Legal guardian is unwilling to inform the minor of their diagnosis.
  • Minor is unwilling to share their thoughts with their parents.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Health services research

Study locations

Taiwan · 1 center
  • Kaohsiung Medical University — Kaohsiung City

Identifiers

NCT: NCT06651242 · KMUHIRB- SV(II)-20220022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗