Design and Testing of a Web-Based Tool for the Improvement of End-of-Life Planning in Patients With Advanced Cancer

NCT05564468 | Completed

• 4 other identifiers: RG1123556R44NR020341NCI-2024-0327920230
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial examines a web-based tool, in partnership with Peacefully, Inc, designed to improve end-of-life planning among patients with advanced cancers. This program helps users prepare comprehensively for end-of-life (e.g., medical wishes, legal estate planning, financial planning and transfer of accounts, legacy building, and emotional support). It is expected that this web-based end-of-life planning program may reduce distress and improve end-of-life preparation among advanced cancer patients.

Conditions

Metastatic Malignant Solid Neoplasm; Hematopoietic and Lymphoid System Neoplasm; Locally Advanced Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (17)

• Accrual

  The number of participants enrolled during the recruitment period.

  Up to 36 months

• Retention rates

  The number of participants who completed all study activities.

  Up to 36 months

• Change in patients' engagement in advance care planning, as measured by the Decision Maker subscale of the Advance Care Planning Engagement Survey: Action Measures, from baseline to 4 weeks post-randomization

  Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Decision Maker (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around advance care planning (e.g., "Have you already decided who you want your medical decision maker to be?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning. Change scores can range from -4 to +4.

  Baseline and Week 4 post-randomization

• Change in patients' engagement in advance care planning, as measured by the Decision Maker subscale of the Advance Care Planning Engagement Survey: Action Measures, from baseline to 12 weeks post-randomization

  Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Decision Maker (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around advance care planning (e.g., "Have you already decided who you want your medical decision maker to be?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning. Change scores can range from -4 to +4.

  Baseline and Week 12 post-randomization

• Change in patients' engagement in advance care planning, as measured by the Decision Maker subscale of the Advance Care Planning Engagement Survey: Action Measures, from baseline to 24 weeks post-randomization

  Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Decision Maker (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around advance care planning (e.g., "Have you already decided who you want your medical decision maker to be?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning. Change scores can range from -4 to +4.

  Baseline and Week 24 post-randomization

• Change in patients' engagement in advance care planning, as measured by the Quality of Life subscale of the Advance Care Planning Engagement Survey: Action Measures, from baseline to 4 weeks post-randomization

  Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Quality of Life (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around quality of life in advance care planning (e.g., "Have you already decided whether or not certain health situations would make your life not worth living?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning as it pertains to quality of life. Change scores can range from -4 to +4.

  Baseline and Week 4 post-randomization

• Change in patients' engagement in advance care planning, as measured by the Quality of Life subscale of the Advance Care Planning Engagement Survey: Action Measures, from baseline to 12 weeks post-randomization

  Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Quality of Life (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around quality of life in advance care planning (e.g., "Have you already decided whether or not certain health situations would make your life not worth living?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning as it pertains to quality of life. Change scores can range from -4 to +4.

  Baseline and Week 12 post-randomization

• Change in patients' engagement in advance care planning, as measured by the Quality of Life subscale of the Advance Care Planning Engagement Survey: Action Measures, from baseline to 24 weeks post-randomization

  Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Quality of Life (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around quality of life in advance care planning (e.g., "Have you already decided whether or not certain health situations would make your life not worth living?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning as it pertains to quality of life. Change scores can range from -4 to +4.

  Baseline and Week 24 post-randomization

• Change in advance care planning engagement: conversations discussing EoL care, living will, HCP, and DNR orders with family members and loved ones, from baseline to 4 weeks post-randomization

  Engagement in ACP with family members and loved ones will be assessed in patients. This outcome will consist of documentation of ACP conversations using the investigators' previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family (4 items) and doctors (4 items). Scores for the family subscale are computed by summing together the total number of ACP topic discussed with the patient's family members and loved ones. Scores can range from 0 to 4, with higher scores indicating increases in engagement in ACP conversations with family members and loved ones.

  Baseline and Week 4 post-randomization

• Change in advance care planning engagement: conversations discussing EoL care, living will, HCP, and DNR orders with family members and loved ones, from baseline to 12 weeks post-randomization

  Engagement in ACP with family members and loved ones will be assessed in patients. This outcome will consist of documentation of ACP conversations using the investigators' previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family (4 items) and doctors (4 items). Scores for the family subscale are computed by summing together the total number of ACP topic discussed with the patient's family members and loved ones. Scores can range from 0 to 4, with higher scores indicating increases in engagement in ACP conversations with family members and loved ones.

  Baseline and Week 12 post-randomization

• Change in advance care planning engagement: conversations discussing EoL care, living will, HCP, and DNR orders with family members and loved ones, from baseline to 24 weeks post-randomization

  Engagement in ACP with family members and loved ones will be assessed in patients. This outcome will consist of documentation of ACP conversations using the investigators' previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family (4 items) and doctors (4 items). Scores for the family subscale are computed by summing together the total number of ACP topic discussed with the patient's family members and loved ones. Scores can range from 0 to 4, with higher scores indicating increases in engagement in ACP conversations with family members and loved ones.

  Baseline and Week 24 post-randomization

• Change in advance care planning engagement: conversations discussing EoL care, living will, HCP, and DNR orders with doctors, from baseline to 4 weeks post-randomization

  Engagement in ACP with doctors will be assessed in patients. This outcome will consist of documentation of ACP conversations using the investigators' previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family (4 items) and doctors (4 items). Scores for the doctor subscale are computed by summing together the total number of ACP topic discussed with the patient's doctors. Scores can range from 0 to 4, with higher scores indicating increases in engagement in ACP conversations with doctors.

  Baseline and Week 4 post-randomization

• Change in advance care planning engagement: conversations discussing EoL care, living will, HCP, and DNR orders with doctors, from baseline to 12 weeks post-randomization

  Engagement in ACP with doctors will be assessed in patients. This outcome will consist of documentation of ACP conversations using the investigators' previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family (4 items) and doctors (4 items). Scores for the doctor subscale are computed by summing together the total number of ACP topic discussed with the patient's doctors. Scores can range from 0 to 4, with higher scores indicating increases in engagement in ACP conversations with doctors.

  Baseline and Week 12 post-randomization

• Change in advance care planning engagement: conversations discussing EoL care, living will, HCP, and DNR orders with doctors, from baseline to 24 weeks post-randomization

  Engagement in ACP with doctors will be assessed in patients. This outcome will consist of documentation of ACP conversations using the investigators' previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family (4 items) and doctors (4 items). Scores for the doctor subscale are computed by summing together the total number of ACP topic discussed with the patient's doctors. Scores can range from 0 to 4, with higher scores indicating increases in engagement in ACP conversations with doctors.

  Baseline and Week 24 post-randomization

• Change in advance care planning engagement: completion of advance directives, from baseline to 4 weeks post-randomization

  Completion of advance directives will be assessed by asking patients whether they completed a do-not-resuscitate order, a living will, and/or identified a health care proxy; data will be verified through the patient's electronic health record. Change in these numbers will be assessed at baseline and post-intervention. Scores are computed by summing together the total number of advance directives completed. Scores can range from 0 to 3, with higher scores indicating increases in completion of advance directives. Change scores can range from -3 to +3.

  Baseline and Week 4 post-randomization

• Change in advance care planning engagement: completion of advance directives, from baseline to 12 weeks post-randomization

  Completion of advance directives will be assessed by asking patients whether they completed a do-not-resuscitate order, a living will, and/or identified a health care proxy; data will be verified through the patient's electronic health record. Change in these numbers will be assessed at baseline and post-intervention. Scores are computed by summing together the total number of advance directives completed. Scores can range from 0 to 3, with higher scores indicating increases in completion of advance directives. Change scores can range from -3 to +3.

  Baseline and Week 12 post-randomization

• Change in advance care planning engagement: completion of advance directives, from baseline to 24 weeks post-randomization

  Completion of advance directives will be assessed by asking patients whether they completed a do-not-resuscitate order, a living will, and/or identified a health care proxy; data will be verified through the patient's electronic health record. Change in these numbers will be assessed at baseline and post-intervention. Scores are computed by summing together the total number of advance directives completed. Scores can range from 0 to 3, with higher scores indicating increases in completion of advance directives. Change scores can range from -3 to +3.

  Baseline and Week 24 post-randomization

Secondary Outcomes (18)

• Change in comprehensive end-of-life planning, from baseline to 4 weeks post-randomization

  Baseline and Week 4 post-randomization

• Change in comprehensive end-of-life planning, from baseline to 12 weeks post-randomization

  Baseline and Week 12 post-randomization

• Change in comprehensive end-of-life planning, from baseline to 24 weeks post-randomization

  Baseline and Week 24 post-randomization

• Change in psychological distress, as measured by the Hospital Anxiety and Depression Scale (HADS), from baseline to 4 weeks post-randomization

  Baseline and Week 4 post-randomization

• Change in psychological distress, as measured by the Hospital Anxiety and Depression Scale (HADS), from baseline to 12 weeks post-randomization

  Baseline and Week 12 post-randomization

Study Arms (2)

Group I (Peacefully's)

EXPERIMENTAL

Patients receive Peacefully's web-based tool to help with end-of-life planning on day 7.

Other: Internet-Based Intervention; Other: Questionnaire Administration

Group II (standard of care)

ACTIVE COMPARATOR

Patients receive standard care.

Other: Best Practice; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Receive standard of care

Also known as: standard of care, standard therapy

Group II (standard of care)

Internet-Based Intervention OTHER

Receive Peacefully's end-of-life planning program

Group I (Peacefully's)

Questionnaire Administration OTHER

Ancillary studies

Group I (Peacefully's); Group II (standard of care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of poor prognosis advanced cancer defined as locally advanced or metastatic cancer and/or disease progression following at least first line systemic therapy
• Access to a computer or mobile device
• The ability to provide informed consent

You may not qualify if:

• Not fluent in English
• Severely cognitively impaired (as measured by Short Portable Mental Status Questionnaire scores of \< 6)
• Too ill or weak to complete the interviews (as judged by the interviewer)

Sponsors & Collaborators

• National Institute of Nursing Research (NINR): collaborator
• Peacefully, Inc.: collaborator
• Fred Hutchinson Cancer Center: lead

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Practice Guidelines as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Megan J. Shen

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 3, 2022
• Study Start: May 21, 2024
• Primary Completion: November 26, 2025
• Study Completion: November 26, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)