NCT06616909

Brief Summary

Background: Globally and nationally, malignant tumors persist as the leading cause of high incidence and mortality rates. In Taiwan, cancer tops the list of causes of death, with the elderly being predominantly affected, especially by lung cancer, which is the most prevalent type with the highest mortality and incidence rates in the nation. The Patient Autonomy Rights Act, implemented by the government in 2019, is designed to promote advance medical care consultation in medical institutions, respecting patient's autonomous decisions. In Chinese culture, medical decisions are typically family-oriented rather than individualistic, leading the elderly to frequently rely on their relatives'choices. This cultural practice may prevent meaningful conversations between potential agents and the elderly, causing misunderstandings of the elderly's preferences and affecting the consistency of medical decisions. Presently, interventions like board games for Advance Care Planning (ACP) are not well received, highlighting the need for more captivating content in intervention strategies.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 23, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 27, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

September 27, 2024

Status Verified

September 1, 2024

Enrollment Period

10 months

First QC Date

September 23, 2024

Last Update Submit

September 25, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Consistency in subsistence disposal preferences between the elderly and potential agents

    Life Support Preferences Questionnaire (LSPQ).

    Outcome Measure Total (3 Time Points): First time: before intervention .Second time: 2 weeks after intervention . Last time: 6 weeks after intervention

Secondary Outcomes (1)

  • STAI

    Outcome Measure Total (4 Time Points): First time: Before intervention. Second time: After intervention. Third time: 2 weeks after intervention .Last time: 6 weeks after intervention

Study Arms (2)

game ACP module

EXPERIMENTAL

,Using board games as an activity intervention, a tool for discussion between elderly people with lung cancer and potential agents

Behavioral: ACP GAME

ACP Manual

PLACEBO COMPARATOR
Behavioral: acp manual

Interventions

ACP GAMEBEHAVIORAL

,Using board games as an activity intervention, a tool for discussion between elderly people with lung cancer and potential agents

game ACP module
acp manualBEHAVIORAL

acp manual

ACP Manual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • lung cancer age ≧ 60
  • The elderly with lung cancer are conscious and have no severe visual or hearing impairment.
  • The potential agent is designated by the elderly person with lung cancer who may be a family member who may make medical decisions in the future. The potential agent must be at least 18 years old.

You may not qualify if:

  • People with severe hearing loss and visual impairment who are unable to communicate in Mandarin and Taiwanese.
  • The potential agent is under 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2024

First Posted

September 27, 2024

Study Start

September 22, 2024

Primary Completion

July 12, 2025

Study Completion

September 30, 2025

Last Updated

September 27, 2024

Record last verified: 2024-09

Locations