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CompletedNCT06061107Updated Feb 28, 2025

Effects of Intervention on Hope, Anxiety, and Attitudes and Behavioral Intentions of Advance Care Planning in Older Adults With Cancer

An interventional study of The cartoon version of the "ACP for Seniors" brochure in Advance Care Planning, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-02-28.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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 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.

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Conditions studied

  • Advance Care Planning
03

In context

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,609 studies on the registry; 574 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Cancer patients aged 65 years or older.
  2. Patients currently undergoing cancer treatment.
  3. Clear consciousness and able to communicate in Mandarin or Taiwanese.
  4. Score of 8 points or higher (inclusive) on the Short Portable Mental State Questionnaire (SPMSQ).

Exclusion criteria

Exclusion Criteria:

  1. Individuals with a score of 7 points or lower (inclusive) on the Short Portable Mental State Questionnaire (SPMSQ).
  2. Individuals who have not been informed about their cancer diagnosis.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Participant)
Enrollment
82 participants (actual)

Study arms

  • 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.

    Behavioral: The cartoon version of the "ACP for Seniors" brochure

  • No intervention
    Control group

    No Intervention: standard clinical care

Interventions

  • BehavioralThe cartoon version of the "ACP for Seniors" brochure

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: three measurement time points: pre-test, two weeks after intervention, and one month after intervention.

  2. 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)

    Time frame: three measurement time points: pre-test, two weeks after intervention, and one month after intervention.

  3. 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.

    Time frame: three measurement time points: pre-test, two weeks after intervention, and one month after intervention.

  4. 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.

    Time frame: three measurement time points: pre-test, two weeks after intervention, and one month after intervention.

07

Study locations

1 site
  • Hsu Ya Hui
    Taipei County, Taiwan
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06061107
Responsible party
Sponsor
First posted
Sep 29, 2023
Start date
Sep 21, 2023
Primary completion
Jul 1, 2024
Completion
Jul 1, 2024
Last update
Feb 28, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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