Cancer PatientsNCT04969952
Evaluation of an Interventional Module to Assist Physicians Introducing ACP to Cancer Patients
A study testing For interventional module in people with Cancer Patients, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
Evaluation of an Interventional module to assist physicians introducing ACP to cancer patients Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Cancer Patients
- What is being tested?
- For interventional module
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 2 sitesTaiwan
- Study dates
- 6 Apr 2021to 20 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 20-years-old
- Diagnosed with cancer
- Have not signed any form of AD or DNR
Who cannot join
- Under 20-years-old
- Can not speak or listen, difficult communication
- Signed AD or DNR
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Nation Taiwan University Hospital
Taipei
National Taiwan University Hospital
Taipei County
About this study
Official title: National Taiwan University Hospital,Taiwan (R.O.C)
Evaluation of an Interventional module to assist physicians introducing ACP to cancer patients
Read the detailed description
Investigators hypothesize that compared to ACP brochure alone, educational module plus ACP brochure is effective in assisting the physicians to introduce ACP to the patients and completion of AD documentation
- Conditions
- Cancer Patients
- Being tested
- For interventional module
- Keywords
- ACP brochure, Interventional Module, Advance directive, cancer patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
For interventional moduleOther
Using vedio to assist physicians introducing advance care planning to cancer patients
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A had watching educational module plus ACP brochure Receives: Other: For interventional module |
| Group B | Active comparator | Group B ACP brochure only Receives: Other: For interventional module |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sign DNR (Do-Not-Resuscitate)
After intervention cancer patients willing sing DNR
Measured: 3 month
Secondary outcomes (1)
Completion AD(Advance directive) documentation
After intervention cancer patients completion of a new AD documentation
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start6 Apr 2021
- Primary completion20 Sep 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PatientsStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Shared decision making (SDM) process through Advance Care Planning (ACP) consultation with cancer patients
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shao-Yi Cheng Shao-Yi, PHD, Principal investigator, Shao-Yi Cheng
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969952
- Sponsor's protocol ID
- 201912238RINA
- Status last verified
- Jun 2024
- First submitted
- 29 Jun 2021
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Taiwan University Hospital,Taiwan (R.O.C)
- ClinicalTrials.gov ID
- NCT04969952
- Acronym / sponsor ID
- 201912238RINA
- Conditions
- Cancer Patients
- Keywords
- ACP brochure, Interventional Module, Advance directive, cancer patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 21 Jul 2021 (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.
Evaluation of an Interventional module to assist physicians introducing ACP to cancer patients
Detailed description
Investigators hypothesize that compared to ACP brochure alone, educational module plus ACP brochure is effective in assisting the physicians to introduce ACP to the patients and completion of AD documentation
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Shared decision making (SDM) process through Advance Care Planning (ACP) consultation with cancer patients
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: For interventional moduleGroup A had watching educational module plus ACP brochure |
| Group B | Active comparator | Other: For interventional moduleGroup B ACP brochure only |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Older than 20-years-old
- Diagnosed with cancer
- Have not signed any form of AD or DNR
Key exclusion criteria (3 listed)
- Under 20-years-old
- Can not speak or listen, difficult communication
- Signed AD or DNR
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 |
|---|---|---|
| For interventional moduleUsing vedio to assist physicians introducing advance care planning to cancer patients | Other | Group A, Group B |
Primary outcome
Sign DNR (Do-Not-Resuscitate)
Time frame: 3 month
After intervention cancer patients willing sing DNR
1 secondary outcome
Completion AD(Advance directive) documentation
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
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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. This study is not recruiting at the moment.
Shao-Yi Cheng Shao-Yi, PHD principal investigator
Shao-Yi Cheng
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing For interventional module in people with Cancer Patients, run by National Taiwan University Hospital at 2 sites 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 3 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: finished, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sign DNR (Do-Not-Resuscitate) (time frame: 3 month). 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 18 Jun 2024.