Clinical trial NCT06651242: Decision Support Intervention of Minor Cancer Patients and Their Parents
Official title: Effectiveness Evaluation on the Decision Preferences and Decision Support Intervention of Minor Cancer Patients and Their Parents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Cancer
Adolescent Health
Decision Aids
Parents of Children With Cancer
Decision Making ,Shared
Keywords: Minor Cancer
Parents
Decision Preferences
Decision Support
Intervention
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2024-10-21
Enrollment: 80
Sex: ALL
Minimum age (years): 7
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria for Parents:

  1. Age over 20 years.
  2. Child under 20 years old, diagnosed with cancer by a doctor.
  3. their child know her/his cancer diagnosis.
  4. Agree to have the child participate in family meeting and have ability to communicate in Mandarin or Taiwanese.
* Inclusion Criteria for Minors:

  1. Aged between 7 and 20 years, diagnosed with pediatrtic cancer.
  2. Aware of their cancer diagnosis.
  3. Able to express their thoughts to the researcher in Mandarin or Taiwanese.
  4. Both the minor and their legal guardian consent to participate in the study.

Exclusion Criteria:

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

Primary outcomes:
measure: Exploring decision-making preferences among parents and minor using the Control Preferences Scale (CPS)
timeFrame: baseline and 1.3.6 months
measure: Exploring the perceived involvement in decision-making among parents and minor using the Perceived Involvement in Care Scale (PICS)
timeFrame: baseline and 1.3.6 months
measure: Exploring decision-making experiences of parents and minor using the Decision Conflict Scale (DCS)
timeFrame: baseline and 1.3.6 months
measure: Exploring perceived family adaptability and cohesion among parents and minor using the Family Adaptability and Cohesion Evaluation Scales IV (FACES IV)
timeFrame: baseline and 1.3.6 months
measure: Exploring minor' coping behaviors in response to illness and treatment using the Paediatric Cancer Coping Scale
timeFrame: baseline and 1.3.6 months
measure: Exploring minor' anxiety levels using the Revised Children's Manifest Anxiety Scale-2 (RCMAS-2)
timeFrame: baseline and 1.3.6 months
measure: Exploring parental anxiety under different characteristics using the State-trait anxiety inventory (STAT)
timeFrame: baseline and 1.3.6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University
Study officials:
References: