Advance Care PlanningNCT06061107
Effects of Intervention on Hope, Anxiety, and Attitudes and Behavioral Intentions of Advance Care Planning in Older Adults With Cancer
A study testing The cartoon version of the "ACP for Seniors" brochure in people with Advance Care Planning, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The study aims to explore the impact of advance care planning on the attitudes, behavioral intentions, hopes, and anxiety of elderly people with cancer on advance care planning with the assistance of the "Advance Care Consultation for the Elderly" manual. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Advance Care Planning
- What is being tested?
- The cartoon version of the "ACP for Seniors" brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Sep 2023to 1 Jul 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Cancer patients aged 65 years or older.
- Patients currently undergoing cancer treatment.
- Clear consciousness and able to communicate in Mandarin or Taiwanese.
- Score of 8 points or higher (inclusive) on the Short Portable Mental State Questionnaire (SPMSQ).
Who cannot join
- Individuals with a score of 7 points or lower (inclusive) on the Short Portable Mental State Questionnaire (SPMSQ).
- Individuals who have not been informed about their cancer diagnosis.
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to explore the impact of advance care planning on the attitudes, behavioral intentions, hopes, and anxiety of elderly people with cancer on advance care planning with the assistance of the "Advance Care Consultation for the Elderly" manual.
Read the detailed description
The experimental group used the cartoon version of the "Advance Care Consultation for the Elderly" manual to guide the ACP process. The process included three parts: an introduction to ACP, an introduction to terminal medical care, and a discussion of what the participants wanted to do about their own health in the past, present, and future required medical care. The estimated time to lead and conduct the ACP conversation is approximately 40 minutes. The control group maintained routine care. The measurement tools are the Advance Care Planning Attitude Scale, Behavioral Intention Scale, Chinese version of Situational Anxiety Inventory-Situational Anxiety Inventory (STAI-S), and Hope State Inventory (Herth Hope Index, HHI) ). There are three measurement time points: pre-test, two weeks after intervention, and one month after intervention. Expected research results: It is expected that intervention measures can improve the positive attitudes and behavioral intentions of elderly people with cancer towards ACP while maintaining their sense of hope without increasing anxiety. It is hoped that the intervention of ACP can enhance the exploration of their own medical preferences and values by the elderly with cancer, and help them become more aware of their own choices and needs when facing treatment decisions in the future.
- Conditions
- Advance Care Planning
- Being tested
- The cartoon version of the "ACP for Seniors" brochure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The cartoon version of the "ACP for Seniors" brochureBehavioural
The experimental group utilized a cartoon version of the "Advance Care Consultation for the Elderly" manual to facilitate the ACP process, which encompassed three components: an introduction to ACP, an overview of terminal medical care, and a discussion about the participants' preferences for their past, current, and future required medical care. There are three measurement time points: pre-test, two weeks after intervention, and one month after intervention.
| Study group | Role | What they receive |
|---|---|---|
| Handbook for Geriatric Prearranged Medical Care Consultation | Experimental | The experimental group utilized a cartoon version of the "Advance Care Consultation for the Elderly" manual to facilitate the ACP process, which encompassed three components: an introduction to ACP, an overview of terminal medical care, and a discussion about the participants' preferences for their past, current, and future required medical care. Receives: Behavioral: The cartoon version of the "ACP for Seniors" brochure |
| Control group | No intervention | No Intervention: standard clinical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attitude Scale
The questionnaire is scored using a 5-point Likert scale. There are a total of 12 questions, resulting in a total score ranging from 24 to 120, with responses ranging from "strongly disagree" (1 point) to "strongly agree" (5 points) . A higher score indicates a more positive attitude among the elderly towards advance care planning.
Measured: three measurement time points: pre-test, two weeks after intervention, and one month after intervention.
Behavioral Intention Scale
The scale is scored using a 5-point Likert scale. There are a total of six questions, resulting in a total score ranging from 6 to 30, with responses ranging from "very unlikely" (1 point) to "very likely" (5 points)
Measured: three measurement time points: pre-test, two weeks after intervention, and one month after intervention.
State Anxiety, A-State，STAI-S
The scale consists of 20 questions, each with 4 options: "completely does not fit," "fits slightly," "fits," and "fits very well." Out of these, 10 questions are positively framed (3, 4, 6, 7, 9, 12, 13, 14, 17, and 18). The scoring is as follows: "1 point" for "completely does not fit," "2 points" for "fits slightly," "3 points" for "fits," and "4 points" for "fits very well." The remaining ten questions are negatively framed, and scoring is reversed, with "4 points" for "completely does not fit," "3 points" for "fits slightly," "2 points" for "fits," and "1 point" for "fits very well." The total score ranges from 20 to 80 points. A higher score indicates a higher level of anxiety, with scores of 20 to 39 indicating mild anxiety, 40 to 59 indicating moderate anxiety, and 60 to 80 indicating severe anxiety.
Measured: three measurement time points: pre-test, two weeks after intervention, and one month after intervention.
Herth Hope Index, HHI
The scale is scored using a 4-point Likert scale, with "1 point" indicating "strongly disagree" and "4 points" indicating "strongly agree," resulting in a total score ranging from 12 to 48 points.
Measured: three measurement time points: pre-test, two weeks after intervention, and one month after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start21 Sep 2023
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advance Care PlanningStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061107
- Sponsor's protocol ID
- 202308006RINC
- Status last verified
- Sep 2023
- First submitted
- 24 Sep 2023
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hsu YH, Wang MH, Hu WY, Ke LS. Effects of advance care planning on hope, anxiety, attitudes, and behavioral intentions in older adults with cancer: A randomized controlled study. Support Care Cancer. 2025 Aug 30;33(9):822. doi: 10.1007/s00520-025-09866-z.
PubMed 40884542
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intervention on Hope, Anxiety, and Attitudes and Behavioral Intentions of Advance Care Planning in Older Adults With Cancer
- ClinicalTrials.gov ID
- NCT06061107
- Acronym / sponsor ID
- 202308006RINC
- Conditions
- Advance Care Planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 29 Sep 2023 (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 study aims to explore the impact of advance care planning on the attitudes, behavioral intentions, hopes, and anxiety of elderly people with cancer on advance care planning with the assistance of the "Advance Care Consultation for the Elderly" manual.
Detailed description
The experimental group used the cartoon version of the "Advance Care Consultation for the Elderly" manual to guide the ACP process. The process included three parts: an introduction to ACP, an introduction to terminal medical care, and a discussion of what the participants wanted to do about their own health in the past, present, and future required medical care. The estimated time to lead and conduct the ACP conversation is approximately 40 minutes. The control group maintained routine care. The measurement tools are the Advance Care Planning Attitude Scale, Behavioral Intention Scale, Chinese version of Situational Anxiety Inventory-Situational Anxiety Inventory (STAI-S), and Hope State Inventory (Herth Hope Index, HHI) ). There are three measurement time points: pre-test, two weeks after intervention, and one month after intervention. Expected research results: It is expected that intervention measures can improve the positive attitudes and behavioral intentions of elderly people with cancer towards ACP while maintaining their sense of hope without increasing anxiety. It is hoped that the intervention of ACP can enhance the exploration of their own medical preferences and values by the elderly with cancer, and help them become more aware of their own choices and needs when facing treatment decisions in the future.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Handbook for Geriatric Prearranged Medical Care Consultation | Experimental | Behavioral: The cartoon version of the "ACP for Seniors" brochureThe experimental group utilized a cartoon version of the "Advance Care Consultation for the Elderly" manual to facilitate the ACP process, which encompassed three components: an introduction to ACP, an overview of terminal medical care, and a discussion about the participants' preferences for their past, current, and future required medical care. |
| Control group | No intervention | –No Intervention: standard clinical care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Cancer patients aged 65 years or older.
- Patients currently undergoing cancer treatment.
- Clear consciousness and able to communicate in Mandarin or Taiwanese.
- Score of 8 points or higher (inclusive) on the Short Portable Mental State Questionnaire (SPMSQ).
Key exclusion criteria (2 listed)
- Individuals with a score of 7 points or lower (inclusive) on the Short Portable Mental State Questionnaire (SPMSQ).
- Individuals who have not been informed about their cancer diagnosis.
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 |
|---|---|---|
| The cartoon version of the "ACP for Seniors" brochureThe experimental group utilized a cartoon version of the "Advance Care Consultation for the Elderly" manual to facilitate the ACP process, which encompassed three components: an introduction to ACP, an overview of terminal medical care, and a discussion about the participants' preferences for their past, current, and future required medical care. There are three measurement time points: pre-test, two weeks after intervention, and one month after intervention. | Behavioural | Handbook for Geriatric Prearranged Medical Care Consultation |
Primary outcome
Attitude Scale
Time frame: three measurement time points: pre-test, two weeks after intervention, and one month after intervention.
The questionnaire is scored using a 5-point Likert scale. There are a total of 12 questions, resulting in a total score ranging from 24 to 120, with responses ranging from "strongly disagree" (1 point) to "strongly agree" (5 points) . A higher score indicates a more positive attitude among the elderly towards advance care planning.
Behavioral Intention Scale
Time frame: three measurement time points: pre-test, two weeks after intervention, and one month after intervention.
The scale is scored using a 5-point Likert scale. There are a total of six questions, resulting in a total score ranging from 6 to 30, with responses ranging from "very unlikely" (1 point) to "very likely" (5 points)
State Anxiety, A-State，STAI-S
Time frame: three measurement time points: pre-test, two weeks after intervention, and one month after intervention.
The scale consists of 20 questions, each with 4 options: "completely does not fit," "fits slightly," "fits," and "fits very well." Out of these, 10 questions are positively framed (3, 4, 6, 7, 9, 12, 13, 14, 17, and 18). The scoring is as follows: "1 point" for "completely does not fit," "2 points" for "fits slightly," "3 points" for "fits," and "4 points" for "fits very well." The remaining ten questions are negatively framed, and scoring is reversed, with "4 points" for "completely does not fit," "3 points" for "fits slightly," "2 points" for "fits," and "1 point" for "fits very well." The total score ranges from 20 to 80 points. A higher score indicates a higher level of anxiety, with scores of 20 to 39 indicating mild anxiety, 40 to 59 indicating moderate anxiety, and 60 to 80 indicating severe anxiety.
Herth Hope Index, HHI
Time frame: three measurement time points: pre-test, two weeks after intervention, and one month after intervention.
The scale is scored using a 4-point Likert scale, with "1 point" indicating "strongly disagree" and "4 points" indicating "strongly agree," resulting in a total score ranging from 12 to 48 points.
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 28 Feb 2025.
- Derived from this study: PubMed 40884542Hsu YH, Wang MH, Hu WY, Ke LS. Effects of advance care planning on hope, anxiety, attitudes, and behavioral intentions in older adults with cancer: A randomized controlled study. Support Care Cancer. 2025 Aug 30;33(9):822. doi: 10.1007/s00520-025-09866-z.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The cartoon version of the "ACP for Seniors" brochure in people with Advance Care Planning, run by National Taiwan University 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 4 inclusion and 2 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 28 Feb 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. 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?
Attitude Scale (time frame: three measurement time points: pre-test, two weeks after intervention, and one month after intervention.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06061107, which also lists 1 linked publication.
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 Feb 2025.