NCT06061107

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

February 28, 2025

Status Verified

September 1, 2023

Enrollment Period

9 months

First QC Date

September 24, 2023

Last Update Submit

February 26, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    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)

    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.

    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.

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

Study Arms (2)

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.

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

Control group

NO INTERVENTION

No Intervention: standard clinical care

Interventions

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.

Handbook for Geriatric Prearranged Medical Care Consultation

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hsu Ya Hui

Taipei County, Taiwan

Location

Related Publications (1)

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2023

First Posted

September 29, 2023

Study Start

September 21, 2023

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

February 28, 2025

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations