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

672 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Facilitated advance care planning (in-person or telephonic), Web-based advance care planning for cancer?

Research shows that web-based advance care planning programs can help patients think about and discuss their future treatment preferences, and online programs like PREPARE have been effective in engaging patients in planning their care. Additionally, good communication, such as through a Values Assessment, is linked to better outcomes at the end of life. ^{1 2 3 4 5}

Is advance care planning safe for cancer patients?

Advance care planning, whether facilitated in-person, telephonically, or through web-based resources, has been found to be feasible and acceptable for patients with advanced illnesses, including cancer. Patients and caregivers have reported high satisfaction with the process, and no significant safety concerns have been noted in the studies reviewed. ^{6 7 8 9 10}

How is the treatment 'Facilitated advance care planning' unique for cancer patients?

Facilitated advance care planning (ACP) is unique because it involves personalized discussions, either in-person or over the phone, to help patients and their families understand and express their preferences for future care. This approach can improve family involvement in decision-making and reduce stress, making it different from standard treatments that may not focus on these aspects. ^{2 7 11 12 13}

What is the purpose of this trial?

The overall goal of this study is to identify the most effective and efficient advance care planning (ACP) strategy for patients with advanced cancer. The specific aims are to: Aim 1. Compare the effectiveness of in-person, facilitated ACP versus web-based ACP on patient and family caregiver outcomes. Aim 2. Assess implementation costs and the effects of in-person, facilitated ACP and web-based ACP on healthcare utilization at end of life. Aim 3. Identify contexts and mechanisms that influence the effectiveness of in-person, facilitated ACP versus web-based ACP.

Research Team

Yael Schenker, MD, MAS

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of an Interactive Website to Engage Patients in Advance Care Planning in Outpatient Settings. [2021]

2. Canada 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Advance Care Planning in Patients With Metastatic Cancer: A Quality Improvement Initiative. [2022]

4. United States 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. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Patient Perspectives on Advance Care Planning via a Patient Portal. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A Yet Unrealized Promise: Structured Advance Care Planning Elements in the Electronic Health Record. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The PREPARE for Your Care program increases advance care planning engagement among diverse older adults with cancer. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of an advance care planning web-based resource: applicability for cancer treatment patients. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of Facilitated Advance Care Planning in Outpatient Clinics: A Qualitative Study of Patient and Caregivers Experiences. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Use of Machine Learning and Lay Care Coaches to Increase Advance Care Planning Conversations for Patients With Metastatic Cancer. [2023]

11. Canada pubmed.ncbi.nlm.nih.gov

Publicly Available, Interactive Web-Based Tools to Support Advance Care Planning: Systematic Review. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Advance care planning-family carer psychological distress and involvement in decision making: the ACTION trial. [2022]

13. England pubmed.ncbi.nlm.nih.gov

'It was like taking an inner bath': A qualitative evaluation of a collaborative advance care planning-approach. [2022]