A Web-Based Advance Care Planning Intervention to Reduce Preferences for Aggressive Life-Sustaining Treatments in Patients With Advanced Cancer: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Change in Preference for Aggressive Life-Sustaining Treatments
Study Overview
Brief Summary
The goal of this clinical trial is to determine whether a web-based advance care planning (ACP) intervention can reduce preferences for aggressive life-sustaining treatments among patients with advanced cancer.
The main questions it aims to answer are:
- Does a web-based ACP intervention reduce preferences for aggressive life-sustaining treatments among patients with advanced cancer?
- Does a web-based ACP intervention support informed medical decision-making regarding future care?
Researchers will compare a web-based ACP intervention plus a Patient Right to Autonomy Act leaflet with a Patient Right to Autonomy Act leaflet alone to determine whether the web-based ACP intervention is more effective in reducing preferences for aggressive life-sustaining treatments.
Participants will:
- Be randomly assigned to either an intervention group or a control group
- Receive either a web-based ACP educational program plus a Patient Right to Autonomy Act leaflet, or a Patient Right to Autonomy Act leaflet alone
- Complete questionnaires at baseline, immediately after the intervention, and one week after the intervention
Detailed Description
Advance care planning (ACP) is a process that enables individuals to understand and communicate their values, goals, and preferences regarding future medical care. ACP is particularly important for patients with advanced cancer, who may face complex decisions regarding life-sustaining treatments and end-of-life care. However, ACP participation remains limited, and innovative approaches are needed to improve patient engagement.
This study was designed to evaluate the effectiveness of a web-based ACP intervention in reducing preferences for aggressive life-sustaining treatments among patients with advanced cancer. The intervention was developed to provide accessible ACP education and information regarding the Patient Right to Autonomy Act in Taiwan.
A single-blind randomized controlled trial design was used. A total of 110 patients with stage III or IV cancer were recruited and randomly assigned to either an intervention group (n = 55) or a control group (n = 55). Participants in the intervention group received a web-based ACP educational program in addition to a Patient Right to Autonomy Act leaflet, whereas participants in the control group received the leaflet alone.
Outcome assessments were conducted at baseline (T1), immediately after the intervention (T2), and one week after the intervention (T3). The primary objective was to determine whether the web-based ACP intervention reduced preferences for aggressive life-sustaining treatments. The study also examined factors associated with treatment preferences and medical decision-making.
The findings of this study may contribute to the development of accessible ACP interventions and support informed decision-making among patients with advanced cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
Outcome assessment and data analysis were conducted by personnel blinded to group allocation. Investigators were not blinded because they were responsible for delivering the intervention and conducting study procedures. Because of the nature of the intervention, participants could identify their group assignment based on the educational materials they received.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosed with advanced cancer (stage III or IV)
- •Aged 18 years or older
- •Able to communicate fluently in Mandarin Chinese or Taiwanese
- •Able and willing to provide informed consent
- •No cognitive impairment
- •Have access to Internet-connected electronic devices at home
- •Have not previously received advance care planning (ACP) consultation
- •Have not completed an advance directive (AD)
Exclusion Criteria
- •No access to Internet-connected electronic devices at home
- •Unable to operate Internet-based electronic devices
- •Previous participation in ACP consultation or completion of an AD
- •Cognitive impairment
- •Severe physical or psychological symptoms that would interfere with participation in the study
- •Concurrent participation in another intervention study
- •Refusal to participate
Arms & Interventions
Web-Based ACP Intervention Group
Participants received a web-based advance care planning (ACP) educational program in addition to a Patient Right to Autonomy Act leaflet.
Intervention: Web-Based Advance Care Planning Program (Behavioral)
Web-Based ACP Intervention Group
Participants received a web-based advance care planning (ACP) educational program in addition to a Patient Right to Autonomy Act leaflet.
Intervention: Patient Right to Autonomy Act Leaflet (Other)
Control Group
Participants received a Patient Right to Autonomy Act leaflet only.
Intervention: Patient Right to Autonomy Act Leaflet (Other)
Outcomes
Primary Outcomes
Change in Preference for Aggressive Life-Sustaining Treatments
Time Frame: Baseline and 1 Week After Intervention
Preferences for aggressive life-sustaining treatments were assessed using the Life-Sustaining Treatment Preference Questionnaire. Higher scores indicate stronger preferences for aggressive life-sustaining treatments. Changes from baseline were compared between the intervention and control groups.
Secondary Outcomes
No secondary outcomes reported
Investigators
Hai-Jou Shih
Principal Investigator
Tri-Service General Hospital (TSGH)