- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06061107
Effects of Intervention on Hope, Anxiety, and Attitudes and Behavioral Intentions of Advance Care Planning in Older Adults With Cancer (ACP)
February 26, 2025 updated by: National Taiwan University Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
82
Phase
- 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 Locations
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Taipei county, Taiwan
- Hsu Ya Hui
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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
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Handbook for Geriatric Prearranged Medical Care Consultation
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.
|
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.
|
|
No Intervention: Control group
No Intervention: standard clinical care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Behavioral Intention Scale
Time Frame: three measurement time points: pre-test, two weeks after intervention, and one month after intervention.
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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)
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three measurement time points: pre-test, two weeks after intervention, and one month after intervention.
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State Anxiety, A-State,STAI-S
Time Frame: three measurement time points: pre-test, two weeks after intervention, and one month after intervention.
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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.
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three measurement time points: pre-test, two weeks after intervention, and one month after intervention.
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Herth Hope Index, HHI
Time Frame: three measurement time points: pre-test, two weeks after intervention, and one month after intervention.
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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.
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three measurement time points: pre-test, two weeks after intervention, and one month after intervention.
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Attitude Scale
Time Frame: three measurement time points: pre-test, two weeks after intervention, and one month after intervention.
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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.
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three measurement time points: pre-test, two weeks after intervention, and one month after intervention.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
September 21, 2023
Primary Completion (Actual)
July 1, 2024
Study Completion (Actual)
July 1, 2024
Study Registration Dates
First Submitted
September 24, 2023
First Submitted That Met QC Criteria
September 24, 2023
First Posted (Actual)
September 29, 2023
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 26, 2025
Last Verified
September 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 202308006RINC
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
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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