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Completed

NCT Number: NCT06061107

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

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.

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Key information

Conditions

Advance Care Planning

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hsu Ya Hui

Taipei County, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The cartoon version of the "ACP for Seniors" brochure

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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)

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 29, 2023
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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