Advance Care Planning Impact on the Consistency of Older Adults With Lung Cancer and Their Potential Surrogates Regarding Life-Sustaining Treatment Preferences

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.

Study Overview

• Status: Active, not recruiting
• Conditions: ELDERLY PEOPLE; Lung Cancer (NSCLC); Advanced Care Planning (ACP)
• Intervention / Treatment: Behavioral: ACP GAME; Behavioral: acp manual

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. lung cancer age ≧ 60
2. The elderly with lung cancer are conscious and have no severe visual or hearing impairment.

3.3. 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: game ACP module; ,Using board games as an activity intervention, a tool for discussion between elderly people with lung cancer and potential agents	Behavioral: ACP GAME; ,Using board games as an activity intervention, a tool for discussion between elderly people with lung cancer and potential agents
Placebo Comparator: ACP Manual	Behavioral: acp manual; acp manual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
STAI	The State-Trait Anxiety Inventory The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety	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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2024
• Primary Completion (Estimated): July 12, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: September 23, 2024
• First Submitted That Met QC Criteria: September 25, 2024
• First Posted (Actual): September 27, 2024

Study Record Updates

• Last Update Posted (Actual): September 27, 2024
• Last Update Submitted That Met QC Criteria: September 25, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 202407186RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No