Pediatric CancerNCT06651242
Decision Support Intervention of Minor Cancer Patients and Their Parents
A study testing Decision-making information aids and Routine care in people with Pediatric Cancer and Adolescent Health, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 20 years
- Conditions the study is for
- Pediatric Cancer, Adolescent Health, Decision Aids
- What is being tested?
- Decision-making information aids and Routine care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Oct 2022to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University
Kaohsiung City
Li-Min Wu, PhD, (886)73121101 ext. 2814, painting@kmu.edu.tw
About this study
Official title: 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.
- Conditions
- Pediatric Cancer, Adolescent Health, Decision Aids, Parents of Children With Cancer, Decision Making ,Shared
- Being tested
- Decision-making information aids, Routine care
- Keywords
- Minor Cancer, Parents, Decision Preferences, Decision Support, Intervention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision-making information aidsOther
Provide a decision-making information aids to assist patients and their parents in treatment decision making.
Routine careOther
Routine care
| Study group | Role | What they receive |
|---|---|---|
| Decision-making information aids | Experimental | Not described Receives: Other: Decision-making information aids |
| Routine care | Sham comparator | Not described Receives: Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: baseline and 1.3.6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start26 Oct 2022
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651242
- Sponsor's protocol ID
- KMUHIRB- SV(II)-20220022
- Status last verified
- Aug 2025
- First submitted
- 18 Oct 2024
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Evaluation on the Decision Preferences and Decision Support Intervention of Minor Cancer Patients and Their Parents
- ClinicalTrials.gov ID
- NCT06651242
- Acronym / sponsor ID
- KMUHIRB- SV(II)-20220022
- Conditions
- Pediatric Cancer, Adolescent Health, Decision Aids, Parents of Children With Cancer, Decision Making ,Shared
- Keywords
- Minor Cancer, Parents, Decision Preferences, Decision Support, Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decision-making information aids | Experimental | Other: Decision-making information aids |
| Routine care | Sham comparator | Other: Routine care |
Who may qualify
- Ages
- 7 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision-making information aidsProvide a decision-making information aids to assist patients and their parents in treatment decision making. | Other | Decision-making information aids |
| Routine careRoutine care | Other | Routine care |
Primary outcome
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.
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.
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.
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.
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.
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).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision-making information aids and Routine care in people with Pediatric Cancer and Adolescent Health, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li-Min Wu, PhD ((886)73121101 ext. 2814, painting@kmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exploring decision-making preferences among parents and minor using the Control Preferences Scale (CPS) (time frame: baseline and 1.3.6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.