Advance Care Planning for Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Hematologic malignancy, No phone, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to assist patients with advanced cancer in planning their future healthcare. It compares two methods: in-person or phone discussions with a guide (facilitated advance care planning) and a web-based tool for planning (web-based advance care planning). The trial will also examine how these methods impact healthcare usage and costs at the end of life. Patients with solid tumors who may not live beyond a year and are open to either form of planning might be suitable candidates. The study also involves caregivers who play a significant role in the patient's care. As an unphased trial, it provides patients the opportunity to contribute to valuable research that could enhance future healthcare planning for others.

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 these advance care planning strategies are safe for patients with advanced cancer?

Research has shown that advance care planning (ACP), whether conducted in person or online, is safe. This planning ensures that medical care aligns with patients' end-of-life wishes. Studies have found that ACP improves engagement and leads to the completion of important documents like advance directives, which are legal papers stating a person's healthcare preferences.

Online tools for advance care planning, such as the PREPARE website, have also undergone study. These tools are user-friendly and often include videos to guide users through the planning steps. Reviews have found these tools effective for patients with cancer, helping them receive more care at home rather than in hospitals.

Both in-person and online methods aim to enhance communication and ensure that medical care respects patients' goals and preferences. No serious safety issues have been reported for either method, indicating that both types of ACP are safe and well-tolerated options for patients considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores unique methods for advance care planning (ACP) in cancer treatment. Unlike traditional approaches, which often involve face-to-face meetings with healthcare providers, this trial examines the effectiveness of facilitated ACP through both in-person/telephonic discussions and a web-based platform. The facilitated ACP uses the Respecting Choices model, which provides structured support for patients, while the web-based option leverages the PREPARE website to offer flexibility and accessibility. These innovative approaches aim to empower patients by making advance care planning more accessible and tailored to individual preferences, potentially improving patient engagement and decision-making about their care.

What evidence suggests that this trial's advance care planning strategies could be effective for patients with advanced cancer?

This trial will compare two methods of advance care planning (ACP) for cancer patients. Research has shown that assistance with ACP, either in person or over the phone, results in more people completing their advance directives compared to some other methods. This approach encourages patients to engage more actively in planning their future healthcare. Participants in one arm of this trial will receive facilitated ACP discussions using the Respecting Choices model.

The other arm will involve web-based ACP via the PREPARE website. Online ACP programs like PREPARE have also succeeded in encouraging patients to plan their care in various settings. Studies have found that online ACP can lead to more care being provided at home rather than in the hospital. Both methods aim to help patients make healthcare decisions that align with their personal values and preferences. ^{1 2 5 6 7}

Who Is on the Research Team?

Yael Schenker, MD, MAS

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for adults with advanced cancer who are expected to continue care at a participating clinic, can participate in either web-based or facilitated advance care planning (ACP), and have someone involved in their care. Excluded are those without phone access, unable to consent, with blood cancers, or unable to complete the baseline interview.

Inclusion Criteria

The doctor thinks that the patient may pass away within the next year.

I can take care of myself and am up and about more than half of my waking hours.

I am the main person taking care of the patient and can participate in the study.

Exclusion Criteria

Unable to participate in advance care planning, as assessed by clinician

I have a blood cancer.

I cannot give informed consent after a teach-back explanation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either in-person facilitated ACP discussions or web-based ACP using interactive videos

12 weeks

Varies based on intervention type

Follow-up

Participants are monitored for outcomes such as ACP engagement and healthcare utilization until 12 weeks after the patient's death or completion of the 48-month data collection period

up to 60 months

What Are the Treatments Tested in This Trial?

Interventions

• Facilitated advance care planning (in-person or telephonic)
• Web-based advance care planning

Trial Overview The study aims to find out which ACP method works best for patients with advanced cancer and their caregivers: an in-person guided discussion or using a web-based program. It will also look at costs and how these methods affect end-of-life healthcare use.

How Is the Trial Designed?

Group I: Facilitated advance care planning (in-person or telephonic) Active Control 1 Intervention

Patients randomized to this arm will participate in in-person or telephonic facilitated advance care planning (ACP) discussions using the Respecting Choices model.

Group II: Web-based advance care planning Active Control 1 Intervention

Patients randomized to this arm will participate in web-based ACP via the PREPARE website.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The PREPARE for Your Care website, combined with an easy-to-read advance directive, significantly increased advance care planning (ACP) documentation among older adults with cancer (62% vs 43%) and those without cancer (38% vs 28%) compared to using an advance directive alone.

Engagement in ACP through the PREPARE program did not lead to increased levels of depression or anxiety, indicating that it is a safe and effective tool for improving ACP among diverse older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The PREPARE for Your Care program increases advance care planning engagement among diverse older adults with cancer. Nouri, SS., Barnes, DE., Shi, Y., et al.[2022]

A study involving 20 semi-structured interviews with patients and caregivers showed that a facilitated advance care planning (ACP) intervention was well-received, with participants finding it clear and tailored to their needs.

Patients receiving the facilitated ACP reported significantly less difficulty in completing their ACP compared to those receiving standard care, suggesting that integrating facilitated ACP into outpatient settings is both feasible and beneficial for individuals with advanced illnesses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of Facilitated Advance Care Planning in Outpatient Clinics: A Qualitative Study of Patient and Caregivers Experiences. Marshall, KH., Riddiford-Harland, DL., Meller, AE., et al.[2023]

The interactive web-based advance care planning (ACP) program significantly increased engagement in ACP among 147 participants with chronic diseases, with scores rising from 2.8 to 3.0 two months after completion (P<.001).

Participants found the program to be usable and understandable, with high satisfaction ratings, indicating it can effectively support initial discussions about treatment preferences and serve as a valuable tool for healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Web-Based Advance Care Planning Program "Explore Your Preferences for Treatment and Care": Development, Pilot Study, and Before-and-After Evaluation. van der Smissen, D., Rietjens, JAC., van Dulmen, S., et al.[2022]

The ACTION Respecting Choices advance care planning intervention did not significantly improve family carers' involvement in decision making during the last three months of a patient's life, although there was a slight increase in involvement in the intervention group (89.6% vs 86.7%).

There was no significant difference in psychological distress between family carers in the intervention and control groups after three months of bereavement, indicating that the ACP intervention did not reduce psychological stress as intended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advance care planning-family carer psychological distress and involvement in decision making: the ACTION trial. Vandenbogaerde, I., De Vleminck, A., Cohen, J., et al.[2022]

In a study of 433 older adults with cancer, only 43.2% had structured advance care planning (ACP) data recorded in electronic health records (EHRs), highlighting a significant gap in data availability.

Among the structured ACP data, only 59.2% were accurate, with a notable presence of incorrect (23.7%) and duplicate (17.1%) entries, indicating reliability issues that could impact patient care and research efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Yet Unrealized Promise: Structured Advance Care Planning Elements in the Electronic Health Record. Lakin, JR., Gundersen, DA., Lindvall, C., et al.[2022]

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 Values Assessment (VA) tool was successfully implemented with 1,268 patients, helping to facilitate advance care planning (ACP) discussions and leading to a higher completion rate of advance directives (57.8%).

Patients who completed advance directives had a significantly higher rate of hospice enrollment (76.1% vs. 60.9%) and experienced less aggressive care at the end of life, with fewer receiving chemotherapy in their final days (8.8% with ADs vs. 15.5% without).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

If We Don't Ask, Our Patients Might Never Tell: The Impact of the Routine Use of a Patient Values Assessment. Hoverman, JR., Taniguchi, C., Eagye, K., et al.[2018]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40106743/

Facilitated Versus Patient-Directed Advance Care Planning ... Facilitated ACP resulted in greater increases in ACP engagement and advance directive completion than patient-directed written and web-based materials.

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/abs/pii/S155171442030149X

Patient-centered and efficacious advance care planning in ... A mixed-methods comparative effectiveness trial of in-person advance care planning (ACP) discussions versus web-based ACP is currently underway at oncology ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2833774

An Intervention to Increase Advance Care Planning Among ... The results of this study suggest that implementing patient video decision aids along with bolstering clinician communication skills can improve clinical ACP ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40528532/

Facilitating Advance Care Planning Conversations Among ... The Hello game has been shown to be effective in promoting ACP in several populations but has not been tested in patients with cancer or their CP.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6559345/

Implementation and Impact of Patient Lay Navigator-led ... Advance care planning (ACP) improves alignment between patient preferences for life-sustaining treatment and care received at end of life (EOL).

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/58/NCT03824158/Prot_SAP_000.pdf

Patient-centered and efficacious advance care planning in ... The purpose of this study is to compare the effectiveness and implementation costs of two different patient-facing ACP interventions among ...