Decision Support Intervention of Minor Cancer Patients and Their Parents

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Cancer; Adolescent Health; Parents of Children With Cancer; Decision Aids; Decision Making ,Shared
• Intervention / Treatment: Other: Routine care; Other: Decision-making information aids

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Li-Min Wu, PhD; Phone Number: 2814 (886)73121101; Email: painting@kmu.edu.tw

Study Locations

• Taiwan
  • Kaohsiung City, Taiwan
    • Recruiting
    • Kaohsiung Medical University
    • Contact: Li-Min Wu, PhD; Phone Number: 2814 (886)73121101; Email: painting@kmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Routine care	Other: Routine care; Routine care
Experimental: Decision-making information aids	Other: Decision-making information aids; Provide a decision-making information aids to assist patients and their parents in treatment decision making.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploring decision-making preferences among parents and minor using the Control Preferences Scale (CPS)	The CPS is a method for assessing individual preferences in medical decision-making roles, consisting of five options that represent five different roles. (A) I prefer to make the decision about which treatment I will receive, (B) I prefer to make the final decision about my treatment after seriously considering my doctor's opinion, (C) I prefer that my doctor and I share responsibility for deciding which treatment is best for me, (D) I prefer that my doctor makes the final decision about which treatment will be used, but seriously considers my opinion, (E) I prefer to leave all decisions regarding treatment to my doctor. The five responses are classified into three categories representing active(A and B), collaborative (C) and passive (D and E) decision-making preference.	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)	This scale comprises 13 items and is divided into three subscales, which measure physician facilitation (4 items), patient information acquisition (4 items), and patient decision-making involvement (4 items). A 5-point Likert scale is used, where higher scores indicate greater perceived involvement in decision-making.	baseline and 1.3.6 months
Exploring decision-making experiences of parents and minor using the Decision Conflict Scale (DCS)	This scale consists of 16 items, with the first 12 items assessing decision experiences, including uncertainty, understanding of information, unclear values, support during the decision-making process, and satisfaction with decisions. It uses a 5-point Likert scale, with higher scores indicating greater decision conflict.	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)	The evaluation of family functioning involves: (1) Balanced Scales: Cohesion and Flexibility, (2) Unbalanced Scales: Disengaged, Enmeshed, Rigid, and Chaotic, (3) Family Communication, and (4) Family Satisfaction. The instrument consists of eight subscales with a total of 62 items, rated on a five-point Likert scale. The Family Cohesion and Flexibility scales include 42 items (0-42), divided into six sections with scores ranging from 7 to 35 per section. The Family Communication scale, which assesses positive communication and openness, contains 10 items (43-52) with scores ranging from 10 to 50. The Family Satisfaction scale, measuring satisfaction with cohesion, flexibility, and communication, also has 10 items (53-62), scoring from 10 to 50. Higher scores on Cohesion and Flexibility suggest a healthier family system; higher scores on Disengaged, Enmeshed, Rigid, and Chaotic indicate dysfunction; higher scores on Communication and Satisfaction denote more positive perceptions.	baseline and 1.3.6 months
Exploring minor' coping behaviors in response to illness and treatment using the Paediatric Cancer Coping Scale	This scale consists of 33 items, scored from 0 ("never") to 3 ("often"). Higher scores indicate more frequent coping behaviors.	baseline and 1.3.6 months
Exploring minor' anxiety levels using the Revised Children's Manifest Anxiety Scale-2 (RCMAS-2)	This 49-item scale assesses four dimensions: defensiveness, physiological anxiety, worry, social anxiety, and performance anxiety. Responses are either "yes" (indicating the presence of a symptom) or "no" (indicating the absence of a symptom).	baseline and 1.3.6 months
Exploring parental anxiety under different characteristics using the State-trait anxiety inventory (STAT)	This scale consists of 20 items measuring individual anxiety traits under different characteristics. It uses a 4-point Likert scale, with higher scores indicating higher levels of anxiety.	baseline and 1.3.6 months

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2022
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: October 18, 2024
• First Submitted That Met QC Criteria: October 18, 2024
• First Posted (Actual): October 21, 2024

Study Record Updates

• Last Update Posted (Estimated): August 28, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Decision Support; Intervention; Parents; Minor Cancer; Decision Preferences
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: KMUHIRB- SV(II)-20220022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No