Clinical trial NCT05564468: Design and Testing of a Web-Based Tool for the Improvement of End-of-Life Planning in Patients With Advanced Cancer
Official title: Testing the Utility of a Novel Website to Help Cancer Patients Plan for Their Future - Phase 2
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic and Lymphoid System Neoplasm
Locally Advanced Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: Peacefully, Inc.
First posted: 2022-10-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: OUTLINE:

Patients are randomized to 1 of 2 groups and their engagement in end-of-life planning is assessed at baseline and four weeks post-randomization.

Group I (intervention): Patients receive Peacefully's web-based tool to help with end-of-life planning on day 7.

Group II (control): Patients receive standard of care.

After completion of study, patients are followed up at 4, 12, and 24 weeks post-randomization.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Accrual
timeFrame: Up to 36 months
measure: Retention rates
timeFrame: Up to 36 months
measure: 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
timeFrame: Baseline and Week 4 post-randomization
measure: 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
timeFrame: Baseline and Week 12 post-randomization
measure: 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
timeFrame: Baseline and Week 24 post-randomization
measure: 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
timeFrame: Baseline and Week 4 post-randomization
measure: 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
timeFrame: Baseline and Week 12 post-randomization
measure: 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
timeFrame: Baseline and Week 24 post-randomization
measure: 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
timeFrame: Baseline and Week 4 post-randomization
measure: 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
timeFrame: Baseline and Week 12 post-randomization
measure: 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
timeFrame: Baseline and Week 24 post-randomization
measure: 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
timeFrame: Baseline and Week 4 post-randomization
measure: 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
timeFrame: Baseline and Week 12 post-randomization
measure: 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
timeFrame: Baseline and Week 24 post-randomization
measure: Change in advance care planning engagement: completion of advance directives, from baseline to 4 weeks post-randomization
timeFrame: Baseline and Week 4 post-randomization
measure: Change in advance care planning engagement: completion of advance directives, from baseline to 12 weeks post-randomization
timeFrame: Baseline and Week 12 post-randomization
measure: Change in advance care planning engagement: completion of advance directives, from baseline to 24 weeks post-randomization
timeFrame: Baseline and Week 24 post-randomization
Secondary outcomes:
measure: Change in comprehensive end-of-life planning, from baseline to 4 weeks post-randomization
timeFrame: Baseline and Week 4 post-randomization
measure: Change in comprehensive end-of-life planning, from baseline to 12 weeks post-randomization
timeFrame: Baseline and Week 12 post-randomization
measure: Change in comprehensive end-of-life planning, from baseline to 24 weeks post-randomization
timeFrame: Baseline and Week 24 post-randomization
measure: Change in psychological distress, as measured by the Hospital Anxiety and Depression Scale (HADS), from baseline to 4 weeks post-randomization
timeFrame: Baseline and Week 4 post-randomization
measure: Change in psychological distress, as measured by the Hospital Anxiety and Depression Scale (HADS), from baseline to 12 weeks post-randomization
timeFrame: Baseline and Week 12 post-randomization
measure: Change in psychological distress, as measured by the Hospital Anxiety and Depression Scale (HADS), from baseline to 24 weeks post-randomization
timeFrame: Baseline and Week 24 post-randomization
measure: Change in emotional well-being, as measured by the Functional Assessment of Cancer Therapy-General (FACT-G) scale, from baseline to 4 weeks post-randomization
timeFrame: Baseline and Week 4 post-randomization
measure: Change in emotional well-being, as measured by the Functional Assessment of Cancer Therapy-General (FACT-G) scale, from baseline to 12 weeks post-randomization
timeFrame: Baseline and Week 12 post-randomization
measure: Change in emotional well-being, as measured by the Functional Assessment of Cancer Therapy-General (FACT-G) scale, from baseline to 24 weeks post-randomization
timeFrame: Baseline and Week 24 post-randomization
measure: Change in social/family well-being, as measured by the Functional Assessment of Cancer Therapy-General scale, from baseline to 4 weeks post-randomization
timeFrame: Baseline and Week 4 post-randomization
measure: Change in social/family well-being, as measured by the Functional Assessment of Cancer Therapy-General scale, from baseline to 12 weeks post-randomization
timeFrame: Baseline and Week 12 post-randomization
measure: Change in social/family well-being, as measured by the Functional Assessment of Cancer Therapy-General scale, from baseline to 24 weeks post-randomization
timeFrame: Baseline and Week 24 post-randomization
measure: Change in spiritual well-being, as measured by the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp), from baseline to 4 weeks post-randomization
timeFrame: Baseline and Week 4 post-randomization
measure: Change in spiritual well-being, as measured by the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale, from baseline to 12 weeks post-randomization
timeFrame: Baseline and Week 12 post-randomization
measure: Change in spiritual well-being, as measured by the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale, from baseline to 24 weeks post-randomization
timeFrame: Baseline and Week 24 post-randomization
measure: Change in financial well-being, as measured by the InCharge Financial Distress/Financial Well-Being scale, from baseline to 4 weeks post-randomization
timeFrame: Baseline and Week 4 post-randomization
measure: Change in financial well-being, as measured by the InCharge Financial Distress/Financial Well-Being scale, from baseline to 12 weeks post-randomization
timeFrame: Baseline and Week 12 post-randomization
measure: Change in financial well-being, as measured by the InCharge Financial Distress/Financial Well-Being scale, from baseline to 24 weeks post-randomization
timeFrame: Baseline and Week 24 post-randomization
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Megan J. Shen
role: PRINCIPAL_INVESTIGATOR
References: