Advanced Care Planning for Sarcoma

Overseen By Megan J Shen, PhD.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fred Hutchinson Cancer Center

Disqualifiers: Non-English speakers, Under 18, others

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

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve how patients with sarcoma, a type of cancer, prepare for future mobility needs after surgery. It uses a checklist to assist patients and their caregivers in planning for life post-surgery, whether the surgery involved limb-saving or limb removal. The goal is to enhance life quality by addressing how mobility changes might affect daily activities. This trial suits English-speaking patients who have undergone limb surgery for sarcoma within the last six months or have advanced sarcoma and are currently receiving treatment. Participants need computer access to complete the online checklist and must be able to provide informed consent. As an unphased trial, it offers a unique opportunity to contribute to research that could improve post-surgery planning and quality of life for future patients.

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 advanced care planning checklist tool is safe for assessing mobility needs in sarcoma patients?

Research has shown that planning ahead for care, such as using a mobility needs checklist, is generally safe. Studies have found that these tools help patients prepare for future needs without causing harm. For instance, reviews indicate that planning ahead often leads to more home care instead of hospital stays, which can improve quality of life. No reports have linked negative effects directly to using these checklists, indicating they are well-tolerated. Participants can feel confident that using the checklist is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Advanced Care Planning (ACP) Mobility Checklist because it offers a novel approach to supportive care for sarcoma patients. Unlike traditional treatments that focus primarily on the physical aspects of the disease, this method emphasizes comprehensive care planning, which can enhance the patient’s quality of life and autonomy. By involving patients in a structured discussion about their care preferences and future health decisions, the checklist aims to empower them and potentially improve their overall healthcare experience. This holistic approach might address unmet needs in the current standard of care, which often overlooks the importance of individualized care planning.

What evidence suggests that the advanced care planning checklist is effective for assessing future mobility needs in sarcoma patients?

Research has shown that using a checklist for planning future care can improve the quality of life for patients with sarcoma. In this trial, participants will complete the Advance Care Planning (ACP) Mobility Checklist, which prepares them for future mobility needs. Studies of similar programs for cancer patients have found that planning ahead can lead to more care at home rather than in the hospital, allowing patients to spend more time in a comfortable setting. Additionally, clear communication and decision-making tools enhance the effectiveness of this planning. Overall, these strategies help patients make informed choices about their care. ^{1 2 5 6 7}

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 English-speaking adults over 18 with sarcoma who've had limb surgery or are in active treatment for stage IV sarcoma. They must be able to consent and have computer access. Caregivers meeting the same criteria can also participate.

Inclusion Criteria

Caregivers must be able to provide informed consent

Caregivers must have access to a computer or other device to fill out the online checklist

Patients must be English speaking

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants complete the Advance Care Planning (ACP) Mobility Checklist and associated questionnaires

4 weeks

Multiple visits for checklist completion and interviews

Follow-up

Participants are monitored for changes in functional status, planning for mobility needs, and engagement in clinical conversations

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Assessment
• Interview
• Questionnaire Administration

Trial Overview The study evaluates a checklist tool designed to assess future mobility needs of sarcoma patients post-surgery or during stage IV treatment, aiming to improve their quality of life by aiding in planning for mobility challenges.

How Is the Trial Designed?

Group I: Supportive Care (advanced care planning checklist) Experimental Treatment 4 Interventions

FIELD TEST: Participants complete the Advance Care Planning (ACP) Mobility Checklist on study. Participants complete questionnaires at baseline and after completing the checklist intervention and undergo interview on study. Participants medical records are also reviewed.

Assessment is already approved in United States, European Union for the following indications:

Approved in United States as Temodar for:

• Glioblastoma multiforme
• Refractory anaplastic astrocytoma

Approved in European Union as Temodal for:

• Glioblastoma multiforme
• Refractory anaplastic astrocytoma

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

Published Research Related to This Trial

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 implementation of an electronic medical record-based goals-of-care template has improved the effectiveness of goals-of-care conversations between oncologists and patients, facilitating better advance care planning and end-of-life discussions.

This template, used in conjunction with a phase 3 trial of palliative care, helps ensure comprehensive coverage of important tasks and enhances communication among healthcare providers, although it has not yet been formally tested for efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Goals-of-care discussions. Saiki, C., Ferrell, B., Longo-Schoeberlein, D., et al.[2019]

The study aims to improve advance care planning (ACP) for older patients with advanced cancer through a Comprehensive ACP Program that includes clinician communication training and patient video decision aids, implemented across 36 oncology clinics with an estimated 11,000 participants.

The primary goal is to increase the completion rate of ACP documentation in electronic health records, which is crucial for enhancing health outcomes for patients and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly (ACP-PEACE): the study protocol for a pragmatic stepped-wedge trial of older patients with cancer. Lakin, JR., Brannen, EN., Tulsky, JA., et al.[2021]

In a survey of 215 patients with advanced cancers, 59% expressed a desire to discuss advance care planning with their physician, indicating a significant interest in addressing end-of-life issues despite their ongoing treatment.

While many patients had some form of advance care planning in place, such as living wills or medical power of attorney, a notable 20% had not discussed these important topics with anyone, highlighting the need for improved communication and support in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advance care planning in patients with cancer referred to a phase I clinical trials program: the MD Anderson Cancer Center experience. Fu, S., Barber, FD., Naing, A., et al.[2014]

The study aims to improve advanced care planning (ACP) discussions for patients aged 65 and older with multimorbidity and impairments by using a nurse navigator and informatics intervention, with 765 eligible patients participating in a randomized trial.

Primary outcomes include the documentation and quality of ACP discussions in electronic health records, assessed over 12 months, which could lead to more person-centered care and better healthcare outcomes for vulnerable patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advance care planning for vulnerable older adults within an Accountable Care Organization: study protocol for the IMPACT randomised controlled trial. Gabbard, J., Pajewski, NM., Callahan, KE., et al.[2020]

Citations

1. trialx.com trialx.com/clinical-trials/listings/294809/a-checklist-advanced-care-planning-for-the-assessment-of-mobility-needs-in-patients-with-sarcoma/

A Checklist (Advanced Care Planning) for The Assessment ... Using an advance care planning mobility needs assessment may help improve the quality of life in patients with sarcoma by helping them plan for ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12405694/

Evaluating outcomes of advance care planning interventions ... Three reviews considered patients with cancer, finding advance care planning resulted in higher proportion of home care versus hospitalisation, ...

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

Patient-centered and efficacious advance care planning in ... This trial will provide new and much-needed empirical evidence about two patient-facing ACP approaches that successfully overcome limitations of traditional ...

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. ascopubs.org ascopubs.org/doi/abs/10.1200/OP.22.00160

Advance Care Planning in Patients With Metastatic Cancer PURPOSE:An initiative aimed to increase the rate of advance care planning (ACP) activities for outpatients with metastatic cancer, ...

6. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05835154?keyword=%22Sarcoma%22

San Mateo Clinical Trial A Checklist (Advanced ... A Checklist (Advanced Care Planning) for The Assessment of Mobility Needs in Patients With Sarcoma ... OUTLINE:~FIELD TEST: Participants complete the advance care ...

7. healthpolicypartnership.com healthpolicypartnership.com/app/uploads/The-sarcoma-policy-checklist.pdf

The Sarcoma Policy Checklist This document was developed by the Sarcoma Policy Checklist expert group, a multi-stakeholder group of experts from the medical, patient advocacy and ...