Decision Support Intervention of Minor Cancer Patients and Their Parents

August 26, 2025 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • Kaohsiung City, Taiwan
        • Recruiting
        • Kaohsiung Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Exploring decision-making preferences among parents and minor using the Control Preferences Scale (CPS)
Time Frame: baseline and 1.3.6 months
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)
Time Frame: baseline and 1.3.6 months
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)
Time Frame: baseline and 1.3.6 months
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)
Time Frame: baseline and 1.3.6 months
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
Time Frame: baseline and 1.3.6 months
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)
Time Frame: baseline and 1.3.6 months
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)
Time Frame: baseline and 1.3.6 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 26, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 21, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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