Hematopoietic and Lymphoid System NeoplasmNCT05564468
Design and Testing of a Web-Based Tool for the Improvement of End-of-Life Planning in Patients With Advanced Cancer
A study testing Best Practice, Internet-Based Intervention and Questionnaire Administration in people with Hematopoietic and Lymphoid System Neoplasm and Locally Advanced Malignant Solid Neoplasm, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid System Neoplasm, Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm
- What is being tested?
- Best Practice, Internet-Based Intervention and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2024to 26 Nov 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Testing the Utility of a Novel Website to Help Cancer Patients Plan for Their Future - Phase 2
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.
Read the 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.
- Conditions
- Hematopoietic and Lymphoid System Neoplasm, Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm
- Being tested
- Best Practice, Internet-Based Intervention, Questionnaire Administration
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive standard of care
Internet-Based InterventionOther
Receive Peacefully's end-of-life planning program
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (Peacefully's) | Experimental | Patients receive Peacefully's web-based tool to help with end-of-life planning on day 7. Receives: Other: Internet-Based Intervention; Other: Questionnaire Administration |
| Group II (standard of care) | Active comparator | Patients receive standard care. Receives: Other: Best Practice; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Comprehensive End-of-life Planning, From Baseline to 4 Weeks Post-randomization
Will be measured using a 14-item checklist of all completed tasks from the checklists/tasks on the website (eg, gather important documents, create a will). Scores are computed by summing together the total number of planning items completed. Scores can range from 0 to 14, with higher scores indicating increases in completion of end-of-life planning tasks. Change scores can range from -14 to +14.
Measured: Baseline and Week 4 post-randomization
Change in Comprehensive End-of-life Planning, From Baseline to 12 Weeks Post-randomization
Will be measured using a 14-item checklist of all completed tasks from the checklists/tasks on the website (eg, gather important documents, create a will). Scores are computed by summing together the total number of planning items completed. Scores can range from 0 to 14, with higher scores indicating increases in completion of end-of-life planning tasks. Change scores can range from -14 to +14.
Measured: Baseline and Week 12 post-randomization
Change in Comprehensive End-of-life Planning, From Baseline to 24 Weeks Post-randomization
Will be measured using a 14-item checklist of all completed tasks from the checklists/tasks on the website (eg, gather important documents, create a will). Scores are computed by summing together the total number of planning items completed. Scores can range from 0 to 14, with higher scores indicating increases in completion of end-of-life planning tasks. Change scores can range from -14 to +14.
Measured: Baseline and Week 24 post-randomization
Secondary outcomes (27)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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/Loved Ones and Doctors, From Baseline to 4 Weeks Post-randomization
Engagement in ACP with family members/loved ones and 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 subscale are computed by summing together the total number of ACP topic discussed with the patient's family members/loved ones and doctors. Scores can range from 0 to 8, with higher scores indicating increases in engagement in ACP conversations with family members/loved ones and doctors. Change scores can range from -8 to +8.
Measured: 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/Loved Ones and Doctors, From Baseline to 12 Weeks Post-randomization
Engagement in ACP with family members/loved ones and 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 subscale are computed by summing together the total number of ACP topic discussed with the patient's family members/loved ones and doctors. Scores can range from 0 to 8, with higher scores indicating increases in engagement in ACP conversations with family members/loved ones and doctors. Change scores can range from -8 to +8.
Measured: 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/Loved Ones and Doctors, From Baseline to 24 Weeks Post-randomization
Engagement in ACP with family members/loved ones and 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 subscale are computed by summing together the total number of ACP topic discussed with the patient's family members/loved ones and doctors. Scores can range from 0 to 8, with higher scores indicating increases in engagement in ACP conversations with family members/loved ones and doctors. Change scores can range from -8 to +8.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 24 post-randomization
Change in Anxiety, as Measured by the Anxiety Subscale of the Hospital Anxiety and Depression Scale (HADS-A), From Baseline to 4 Weeks Post-randomization
Anxiety will be measured using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A), a valid and reliable 7-item, Likert-type self-report measure of mood disturbance commonly used with cancer patients. Each item on this scale is rated on a 4-point scale (0 to 3), and all items are summed to create a HADS-A total score. Total scores can range from 0 to 21, with higher numbers indicating higher levels of anxiety. Change in anxiety will be assessed at baseline and 4 weeks post-randomization. Change scores can range from -21 to +21.
Measured: Baseline and Week 4 post-randomization
Change in Anxiety, as Measured by the Anxiety Subscale of the Hospital Anxiety and Depression Scale (HADS-A), From Baseline to 12 Weeks Post-randomization
Anxiety will be measured using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A), a valid and reliable 7-item, Likert-type self-report measure of mood disturbance commonly used with cancer patients. Each item on this scale is rated on a 4-point scale (0 to 3), and all items are summed to create a HADS-A total score. Total scores can range from 0 to 21, with higher numbers indicating higher levels of anxiety. Change in anxiety will be assessed at baseline and post-randomization. Change scores can range from -21 to +21.
Measured: Baseline and Week 12 post-randomization
Change in Anxiety, as Measured by the Anxiety Subscale of the Hospital Anxiety and Depression Scale (HADS-A), From Baseline to 24 Weeks Post-randomization
Anxiety will be measured using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A), a valid and reliable 7-item, Likert-type self-report measure of mood disturbance commonly used with cancer patients. Each item on this scale is rated on a 4-point scale (0 to 3), and all items are summed to create a HADS-A total score. Total scores can range from 0 to 21, with higher numbers indicating higher levels of anxiety. Change in anxiety will be assessed at baseline and post-randomization. Change scores can range from -21 to +21.
Measured: Baseline and Week 24 post-randomization
Change in Psychological Distress, as Measured by the Center for Epidemiological Studies Depression Scale (CESD), From Baseline to 4 Weeks Post-randomization
Psychological Distress will be measured using the Center for Epidemiological Studies Depression Scale (CESD), a valid and reliable 20-item, Likert-type self-report measure of frequency and severity of depressive symptoms over the previous week. Each item on this scale is rated on a 4-point scale (0 to 3), and all items are summed to create a total score. Total scores can range from 0 to 60, with higher numbers indicating higher levels of psychological distress. Change in psychological distress will be assessed at baseline and 4 weeks post-randomization. Change scores can range from -60 to +60.
Measured: Baseline and Week 4 post-randomization
Change in Psychological Distress, as Measured by the Center for Epidemiological Studies Depression Scale (CESD), From Baseline to 12 Weeks Post-randomization
Psychological Distress will be measured using the Center for Epidemiological Studies Depression Scale (CESD), a valid and reliable 20-item, Likert-type self-report measure of frequency and severity of depressive symptoms over the previous week. Each item on this scale is rated on a 4-point scale (0 to 3), and all items are summed to create a total score. Total scores can range from 0 to 60, with higher numbers indicating higher levels of psychological distress. Change in psychological distress will be assessed at baseline and 12 weeks post-randomization. Change scores can range from -60 to +60.
Measured: Baseline and week 12 post-randomization
Change in Psychological Distress, as Measured by the Center for Epidemiological Studies Depression Scale (CESD), From Baseline to 24 Weeks Post-randomization
Psychological Distress will be measured using the Center for Epidemiological Studies Depression Scale (CESD), a valid and reliable 20-item, Likert-type self-report measure of frequency and severity of depressive symptoms over the previous week. Each item on this scale is rated on a 4-point scale (0 to 3), and all items are summed to create a total score. Total scores can range from 0 to 60, with higher numbers indicating higher levels of psychological distress. Change in psychological distress will be assessed at baseline and 24 weeks post-randomization. Change scores can range from -60 to +60.
Measured: Baseline and Week 24 post-randomization
Change in Emotional Social Well-being, as Measured by the Functional Assessment of Cancer Therapy-General (FACT-G) Scale, From Baseline to 4 Weeks Post-randomization
Emotional and social well-being will be measured using the 27-item Functional Assessment of Cancer Therapy-General (FACT-G) scale. The FACT-G scale contains 27 items that ask patients to rate the degree to which they agree to statements about their well-being. Each item on this scale is rated on a 5-point Likert scale (0 = not at all, 4 = very much), with higher scores indicating better well-being. Total scores can range from 0-108. Change in emotional and social well-being will be assessed at baseline and 4 weeks post-randomization. Change scores can range from -108 to +108.
Measured: Baseline and Week 4 post-randomization
Change in Emotional Social Well-being, as Measured by the Functional Assessment of Cancer Therapy-General (FACT-G) Scale, From Baseline to 12 Weeks Post-randomization
Emotional and social well-being will be measured using the 27-item Functional Assessment of Cancer Therapy-General (FACT-G) scale. The FACT-G scale contains 27 items that ask patients to rate the degree to which they agree to statements about their well-being. Each item on this scale is rated on a 5-point Likert scale (0 = not at all, 4 = very much), with higher scores indicating better well-being. Total scores can range from 0-108. Change in emotional and social well-being will be assessed at baseline and 12 weeks post-randomization. Change scores can range from -108 to +108.
Measured: Baseline and Week 12 post-randomization
Change in Emotional Social Well-being, as Measured by the Functional Assessment of Cancer Therapy-General (FACT-G) Scale, From Baseline to 24 Weeks Post-randomization
Emotional and social well-being will be measured using the 27-item Functional Assessment of Cancer Therapy-General (FACT-G) scale. The FACT-G scale contains 27 items that ask patients to rate the degree to which they agree to statements about their well-being. Each item on this scale is rated on a 5-point Likert scale (0 = not at all, 4 = very much), with higher scores indicating better well-being. Total scores can range from 0-108. Change in emotional and social well-being will be assessed at baseline and 24 weeks post-randomization. Change scores can range from -108 to +108.
Measured: Baseline and Week 24 post-randomization
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
Spiritual well-being will be measured using the validated, 12-item Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp). The FACIT-Sp asks patients to indicate the degree to which they agree with statements about their spiritual well-being. Each item on this scale is rated on a 5-point Likert scale (0 = not at all, 4 = very much), with higher scores indicating greater spiritual well-being. Total scores range from 0 to 48. Change in spiritual well-being will be assessed at baseline and 4 weeks post-randomization. Change scores can range from -48 to +48.
Measured: Baseline and Week 4 post-randomization
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
Spiritual well-being will be measured using the validated, 12-item Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp). The FACIT-Sp asks patients to indicate the degree to which they agree with statements about their spiritual well-being. Each item on this scale is rated on a 5-point Likert scale (0 = not at all, 4 = very much), with higher scores indicating greater spiritual well-being. Total scores range from 0 to 48. Change in spiritual well-being will be assessed at baseline and 12 weeks post-randomization. Change scores can range from -48 to +48.
Measured: Baseline and Week 12 post-randomization
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
Spiritual well-being will be measured using the validated, 12-item Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp). The FACIT-Sp asks patients to indicate the degree to which they agree with statements about their spiritual well-being. Each item on this scale is rated on a 5-point Likert scale (0 = not at all, 4 = very much), with higher scores indicating greater spiritual well-being. Total scores range from 0 to 48. Change in spiritual well-being will be assessed at baseline and 24 weeks post-randomization. Change scores can range from -48 to +48.
Measured: Baseline and Week 24 post-randomization
Change in Financial Well-being, as Measured by the InCharge Financial Distress/Financial Well-Being Scale, From Baseline to 4 Weeks Post-randomization
Financial well-being will be measured using the validated, 8-item InCharge Financial Distress/Financial Well-Being scale. This scale asks patients to rate their financial wellness (stress, satisfaction, etc.) on a 10-point Likert scale that varies for each response but for which 1 indicates the lowest financial well-being and 10 indicates the highest (e.g., 1=overwhelming stress to 10 = not stress at all; 1 = worry all the time, 10 - never worry). Total scores range from 8 to 80, with higher scores indicating greater financial well-being. Change in financial well-being will be assessed at baseline and 4 weeks post-randomization. Change scores can range from -72 to +72.
Measured: Baseline and Week 4 post-randomization
Change in Financial Well-being, as Measured by the InCharge Financial Distress/Financial Well-Being Scale, From Baseline to 12 Weeks Post-randomization
Financial well-being will be measured using the validated, 8-item InCharge Financial Distress/Financial Well-Being scale. This scale asks patients to rate their financial wellness (stress, satisfaction, etc.) on a 10-point Likert scale that varies for each response but for which 1 indicates the lowest financial well-being and 10 indicates the highest (e.g., 1=overwhelming stress to 10 = not stress at all; 1 = worry all the time, 10 - never worry). Total scores range from 8 to 80, with higher scores indicating greater financial well-being. Change in financial well-being will be assessed at baseline and 12 weeks post-randomization. Change scores can range from -72 to +72.
Measured: Baseline and Week 12 post-randomization
Change in Financial Well-being, as Measured by the InCharge Financial Distress/Financial Well-Being Scale, From Baseline to 24 Weeks Post-randomization
Financial well-being will be measured using the validated, 8-item InCharge Financial Distress/Financial Well-Being scale. This scale asks patients to rate their financial wellness (stress, satisfaction, etc.) on a 10-point Likert scale that varies for each response but for which 1 indicates the lowest financial well-being and 10 indicates the highest (e.g., 1=overwhelming stress to 10 = not stress at all; 1 = worry all the time, 10 - never worry). Total scores range from 8 to 80, with higher scores indicating greater financial well-being. Change in financial well-being will be assessed at baseline and 24 weeks post-randomization. Change scores can range from -72 to +72.
Measured: Baseline and Week 24 post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start21 May 2024
- Primary completion26 Nov 2025
- Study completion26 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hematopoietic and Lymphoid System NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Peacefully, Inc.
- Responsible party
- Principal investigator, Megan Shen, Fred Hutchinson Cancer Center
- Investigators
- Megan J. Shen, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564468
- Sponsor's protocol ID
- RG1123556
- Other IDs
- R44NR020341, NCI-2024-03279, 20230
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2022
- Last updated
- 2 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Utility of a Novel Website to Help Cancer Patients Plan for Their Future - Phase 2
- ClinicalTrials.gov ID
- NCT05564468
- Acronym / sponsor ID
- RG1123556
- Conditions
- Hematopoietic and Lymphoid System Neoplasm, Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Peacefully, Inc.
- Study start
- 21 May 2024 (actual)
- Primary completion
- 26 Nov 2025 (actual)
- Study completion
- 26 Nov 2025 (actual)
- First posted
- 3 Oct 2022 (actual)
- Results
- Posted 2 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (Peacefully's) | Experimental | Other: Internet-Based Intervention, Other: Questionnaire AdministrationPatients receive Peacefully's web-based tool to help with end-of-life planning on day 7. |
| Group II (standard of care) | Active comparator | Other: Best Practice, Other: Questionnaire AdministrationPatients receive standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive standard of care | Other | Group II (standard of care) |
| Internet-Based InterventionReceive Peacefully's end-of-life planning program | Other | Group I (Peacefully's) |
| Questionnaire AdministrationAncillary studies | Other | Group I (Peacefully's), Group II (standard of care) |
Primary outcome
Change in Comprehensive End-of-life Planning, From Baseline to 4 Weeks Post-randomization
Time frame: Baseline and Week 4 post-randomization
Will be measured using a 14-item checklist of all completed tasks from the checklists/tasks on the website (eg, gather important documents, create a will). Scores are computed by summing together the total number of planning items completed. Scores can range from 0 to 14, with higher scores indicating increases in completion of end-of-life planning tasks. Change scores can range from -14 to +14.
Change in Comprehensive End-of-life Planning, From Baseline to 12 Weeks Post-randomization
Time frame: Baseline and Week 12 post-randomization
Will be measured using a 14-item checklist of all completed tasks from the checklists/tasks on the website (eg, gather important documents, create a will). Scores are computed by summing together the total number of planning items completed. Scores can range from 0 to 14, with higher scores indicating increases in completion of end-of-life planning tasks. Change scores can range from -14 to +14.
Change in Comprehensive End-of-life Planning, From Baseline to 24 Weeks Post-randomization
Time frame: Baseline and Week 24 post-randomization
Will be measured using a 14-item checklist of all completed tasks from the checklists/tasks on the website (eg, gather important documents, create a will). Scores are computed by summing together the total number of planning items completed. Scores can range from 0 to 14, with higher scores indicating increases in completion of end-of-life planning tasks. Change scores can range from -14 to +14.
27 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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/Loved Ones and Doctors, From Baseline to 4 Weeks Post-randomization
Time frame: 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/Loved Ones and Doctors, From Baseline to 12 Weeks Post-randomization
Time frame: 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/Loved Ones and Doctors, From Baseline to 24 Weeks Post-randomization
Time frame: Baseline and Week 24 post-randomization
Change in Advance Care Planning Engagement: Completion of Advance Directives, From Baseline to 4 Weeks Post-randomization
Time frame: Baseline and Week 4 post-randomization
Change in Advance Care Planning Engagement: Completion of Advance Directives, From Baseline to 12 Weeks Post-randomization
Time frame: Baseline and Week 12 post-randomization
Change in Advance Care Planning Engagement: Completion of Advance Directives, From Baseline to 24 Weeks Post-randomization
Time frame: Baseline and Week 24 post-randomization
Change in Anxiety, as Measured by the Anxiety Subscale of the Hospital Anxiety and Depression Scale (HADS-A), From Baseline to 4 Weeks Post-randomization
Time frame: Baseline and Week 4 post-randomization
Change in Anxiety, as Measured by the Anxiety Subscale of the Hospital Anxiety and Depression Scale (HADS-A), From Baseline to 12 Weeks Post-randomization
Time frame: Baseline and Week 12 post-randomization
Change in Anxiety, as Measured by the Anxiety Subscale of the Hospital Anxiety and Depression Scale (HADS-A), From Baseline to 24 Weeks Post-randomization
Time frame: Baseline and Week 24 post-randomization
Change in Psychological Distress, as Measured by the Center for Epidemiological Studies Depression Scale (CESD), From Baseline to 4 Weeks Post-randomization
Time frame: Baseline and Week 4 post-randomization
Change in Psychological Distress, as Measured by the Center for Epidemiological Studies Depression Scale (CESD), From Baseline to 12 Weeks Post-randomization
Time frame: Baseline and week 12 post-randomization
Change in Psychological Distress, as Measured by the Center for Epidemiological Studies Depression Scale (CESD), From Baseline to 24 Weeks Post-randomization
Time frame: Baseline and Week 24 post-randomization
Change in Emotional Social Well-being, as Measured by the Functional Assessment of Cancer Therapy-General (FACT-G) Scale, From Baseline to 4 Weeks Post-randomization
Time frame: Baseline and Week 4 post-randomization
Change in Emotional Social Well-being, as Measured by the Functional Assessment of Cancer Therapy-General (FACT-G) Scale, From Baseline to 12 Weeks Post-randomization
Time frame: Baseline and Week 12 post-randomization
Change in Emotional Social Well-being, as Measured by the Functional Assessment of Cancer Therapy-General (FACT-G) Scale, From Baseline to 24 Weeks Post-randomization
Time frame: Baseline and Week 24 post-randomization
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
Time frame: Baseline and Week 4 post-randomization
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
Time frame: Baseline and Week 12 post-randomization
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
Time frame: Baseline and Week 24 post-randomization
Change in Financial Well-being, as Measured by the InCharge Financial Distress/Financial Well-Being Scale, From Baseline to 4 Weeks Post-randomization
Time frame: Baseline and Week 4 post-randomization
Change in Financial Well-being, as Measured by the InCharge Financial Distress/Financial Well-Being Scale, From Baseline to 12 Weeks Post-randomization
Time frame: Baseline and Week 12 post-randomization
Change in Financial Well-being, as Measured by the InCharge Financial Distress/Financial Well-Being Scale, From Baseline to 24 Weeks Post-randomization
Time frame: Baseline and Week 24 post-randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan J. Shen principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Internet-Based Intervention and Questionnaire Administration in people with Hematopoietic and Lymphoid System Neoplasm and Locally Advanced Malignant Solid Neoplasm, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Comprehensive End-of-life Planning, From Baseline to 4 Weeks Post-randomization (time frame: Baseline and Week 4 post-randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.