Web-Based End-of-Life Planning Tool for Cancer

Overseen By Megan J Shen, PhD.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fred Hutchinson Cancer Center

Disqualifiers: Non-English, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online tool designed to assist people with advanced cancer in planning for the end of life. Developed with Peacefully, Inc, the tool addresses medical wishes, legal and financial plans, legacy building, and emotional support. The researchers aim to determine if this tool can reduce stress and enhance patients' preparedness for end-of-life decisions. Individuals with advanced cancer who have completed at least one treatment and have access to a computer or smartphone may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative solutions for end-of-life planning.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this web-based tool is safe for end-of-life planning?

Research has not provided specific safety data for Peacefully's online tool for planning end-of-life care. However, this tool assists patients with advanced cancer in planning for their end-of-life needs. As an online program, it does not involve medications or physical treatments, which generally means there are no physical risks or side effects. Users can expect it to help them make decisions about medical wishes, legal matters, and emotional support without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it introduces a web-based tool specifically designed to assist with end-of-life planning for cancer patients. Unlike traditional approaches, which typically involve in-person consultations, this digital tool offers a more accessible and convenient way for patients to plan their end-of-life care on their own terms and timeline. This tool empowers patients to make informed decisions from the comfort of their home, potentially enhancing their sense of control and peace during a challenging time.

What evidence suggests that this web-based tool is effective for end-of-life planning in advanced cancer patients?

Research has shown that online tools can greatly improve the quality of life for cancer patients. One study found that tracking symptoms electronically boosted the well-being of lung cancer patients. In this trial, participants in Group I will use Peacefully's web-based tool for end-of-life planning. Similar tools are being tested to improve care planning for those with advanced cancer. Early palliative care, which these tools can support, benefits both patients and their caregivers. Although specific data for Peacefully's tool is not yet available, these findings suggest that online end-of-life planning tools could help reduce stress and aid in preparation. ^{3 6 7 8 9}

Who Is on the Research Team?

Megan J Shen, PhD.

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for adults with advanced cancer, who have a life expectancy of less than 12 months and have undergone at least one round of chemotherapy. Participants must be able to use a computer or mobile device, give informed consent, and speak English fluently. Those severely cognitively impaired or too ill to complete interviews are excluded.

Inclusion Criteria

The ability to provide informed consent

My cancer is advanced or has spread, and it got worse after my first chemotherapy.

Clinician estimated prognosis of =< 12 months

Exclusion Criteria

Too ill or weak to complete the interviews (as judged by the interviewer)

Severely cognitively impaired (as measured by Short Portable Mental Status Questionnaire scores of < 6)

I am not fluent in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

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

4 weeks

Baseline and 4 weeks post-randomization

Control

Patients receive standard care

4 weeks

Baseline and 4 weeks post-randomization

Follow-up

Participants are monitored for changes in well-being and end-of-life planning engagement

24 weeks

Follow-up at 4, 12, and 24 weeks post-randomization

What Are the Treatments Tested in This Trial?

Interventions

• Web-Based Tool for End-of-Life Planning

Trial Overview The study tests a web-based tool created with Peacefully, Inc., aimed at helping patients with advanced cancers plan for end-of-life. It covers medical wishes, legal estate planning, financial matters, legacy building, and emotional support to potentially ease distress and improve preparation.

How Is the Trial Designed?

Group I: Group I (Peacefully's) Experimental Treatment 2 Interventions

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

Group II: Group II (standard of care) Active Control 2 Interventions

Patients receive standard care.

Web-Based Tool for End-of-Life Planning is already approved in United States for the following indications:

Approved in United States as Peacefully for:

• End-of-life planning for patients with advanced cancers

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

Peacefully, Inc.

Collaborator

Trials

1

Recruited

100+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

The systematic review identified 30 interactive web-based advance care planning (ACP) tools, with varying formats and quality, highlighting that 80% of these tools had clear aims related to reflection, decision-making, and documentation support.

Quality scores for the tools ranged from 11 to 28, indicating that many tools lacked proper information sources, suggesting a need for better development processes involving users and scientific evidence to enhance content quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Publicly Available, Interactive Web-Based Tools to Support Advance Care Planning: Systematic Review. Dupont, C., Smets, T., Monnet, F., et al.[2022]

The Tell Us™ Web-based tool was developed to enhance communication and symptom management among hospice and palliative care patients, caregivers, and providers, based on feedback from clinicians and researchers.

This tool allows for the collection of patient-reported outcomes, automated alerts for providers regarding patient needs, and educational resources, aiming to improve proactive patient management and overall care effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tell Us™: a Web-based tool for improving communication among patients, families, and providers in hospice and palliative care through systematic data specification, collection, and use. Dy, SM., Roy, J., Ott, GE., et al.[2022]

A free online resource has been developed to assist nurses and healthcare staff in delivering palliative and end-of-life care for patients with terminal illnesses.

This resource aims to improve the quality of care provided to patients during their final stages of life, ensuring that healthcare professionals have access to essential information and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online tool targets better skills in end of life care. Jones-Berry, S.[2019]

The PREPARE web-based resource for advance care planning was found to be acceptable, applicable, and understandable for oncology patients, based on feedback from 21 participants receiving cancer treatment.

Some participants expressed difficulty with the language related to life-limiting conditions, suggesting a need for revisions to ensure it does not cause distress or disengagement from advance care planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an advance care planning web-based resource: applicability for cancer treatment patients. Cresswell, MA., Robinson, CA., Fyles, G., et al.[2022]

The MyPal platform is designed to enhance palliative care for adults with hematologic malignancies by utilizing electronic patient-reported outcomes (ePROs) to capture patients' self-assessed health status, which can improve treatment efficacy from the patient's perspective.

Currently in pilot testing, MyPal aims to facilitate better communication between patients and healthcare providers through regular questionnaires and symptom reporting, potentially improving the quality of life for patients receiving palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fostering Palliative Care Through Digital Intervention: A Platform for Adult Patients With Hematologic Malignancies. Koumakis, L., Schera, F., Parker, H., et al.[2022]

Health professionals have varying attitudes towards adapting the palliative care outcome scale (POS) for use on hand-held computers, indicating a need for further exploration of their views.

The study highlights specific challenges in integrating computerized clinical outcome measures in palliative care, emphasizing the importance of understanding these issues to improve patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is the potential for the use of clinical outcome measures to be computerised? Findings from a qualitative research study. Hughes, RA., Sinha, A., Aspinal, F., et al.[2019]

A web-based tool was developed to assist women with ovarian cancer in advance care planning, focusing on advance healthcare directives and palliative care, and was tested in a pilot study with 53 participants.

While the tool did not significantly increase the completion rates of advance healthcare directives or palliative care consultations, it did help reduce decisional conflict and improve user satisfaction with the information provided.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and pilot of an advance care planning website for women with ovarian cancer: a randomized controlled trial. Vogel, RI., Petzel, SV., Cragg, J., et al.[2021]

The Communicating Health Alternatives Tool (CHAT) was developed to help clinicians initiate end-of-life conversations with older adults, aiming to improve shared decision-making and reduce overtreatment in the last year of life.

User testing showed that clinicians, patients, and caregivers found CHAT easy to use and acceptable, suggesting it could effectively facilitate advance care planning and lead to better alignment of treatment with patient preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and preliminary usability testing of an electronic conversation guide incorporating patient values and prognostic information in preparation for older people's decision-making near the end of life. Cardona, M., Lewis, ET., Bannach-Brown, A., et al.[2023]

Digital technologies, like Electronic Palliative Care Coordination Systems (EPaCCS), are being explored to enhance advance care planning and coordination in palliative care, but the evidence supporting their effectiveness is still limited.

Research is essential to evaluate whether technology-mediated approaches, such as EPaCCS, can effectively improve care delivery for patients with chronic and progressive illnesses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building on sand: digital technologies for care coordination and advance care planning. Allsop, MJ., Chumbley, K., Birtwistle, J., et al.[2022]

The use of interactive communication via the Internet can significantly improve access to palliative care for patients in underserved areas, enhancing the quality of care for those with advanced diseases.

A collaborative consultation model demonstrated between a rural palliative care nurse practitioner and an urban physician shows that online expert consultations can empower healthcare providers with up-to-date information, leading to better clinical decision-making and timely interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive collaborative consultation model in end-of-life care. Kuebler, KK., Bruera, E.[2019]

A Web-based advance care planning tool for lung disease received high acceptability and potential usefulness ratings from 50 stakeholders, including patients, surrogates, and clinicians, indicating strong support for its development.

Stakeholders suggested that the tool should include videos, interactive content, and allow users to control their progress, while also addressing challenges like emotional difficulties and varying levels of computer literacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Key stakeholders' perspectives on a Web-based advance care planning tool for advanced lung disease. Chiarchiaro, J., Ernecoff, NC., Buddadhumaruk, P., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12223247/

Effectiveness of symptom monitoring on electronic patient ... The meta-analysis showed significant improvement in health-related quality of life (SMD = 2.44, P < 0.001) among patients with lung cancer.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03824158

Patient-centered and Efficacious Advance Care Planning ... The overall goal of this study is to identify the most effective and efficient advance care planning (ACP) strategy for patients with advanced cancer.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0738399125000734

Web-based educational tools and decision aids for patients ... Sixteen web-based tools were identified: Seven for breast cancer, six for other specific cancers, and three for mixed populations.

4. journals.sagepub.com journals.sagepub.com/doi/full/10.1089/jpm.2024.0375

Feasibility Study of Using Electronic Patient-Reported ... Early palliative care for patients with advanced cancer is an evidence-based practice that improves patient and caregiver outcomes, including patient-reported ...

5. ascopubs.org ascopubs.org/doi/10.1200/CCI.20.00015

Electronic Patient-Reported Outcome–Based Interventions ... We performed a systematic and mapping review of the scientific literature on the current ePRO-based approaches used for palliative cancer care.

6. fredhutch.org fredhutch.org/en/news/spotlight/2023/12/crd-supportivecareincancer-walsh.html

Peacefully: an online tool to give peace of mind and assist ... Peacefully: an online tool to give peace of mind and assist with end-of-life planning ... life planning website for patients with advanced cancer ...

7. withpower.com withpower.com/trial/web-based-end-of-life-planning-tool-for-cancer-096fa

Web-Based End-of-Life Planning Tool for Cancer Is the Web-Based End-of-Life Planning Tool safe for use in humans? The available research does not provide specific safety data for the Web-Based End-of- ...

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK599854/

Artificial Intelligence Decision Support Tools for End-of-Life ... AI-based behavioural nudges have the potential to assist clinicians in identifying high-risk patients for short-term mortality and initiating end-of-life ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S155171442030149X

Patient-centered and efficacious advance care planning in ... Development and refinement of a novel end-of-life planning website for patients with advanced cancer: a mixed methods approach. 2023, Supportive Care in Cancer ...