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

Trial Summary

What is the purpose of this trial?

This trial tests how well the advanced care planning around mobility needs checklist tool works to assess future mobility needs in patients with sarcoma. Gathering information about sarcoma patients that have had surgery to either save or remove a limb may help doctors learn more about a patient's mobility needs. Using an advance care planning mobility needs assessment may help improve the quality of life in patients with sarcoma by helping them plan for their future mobility needs.

Will I have to stop taking my current medications?

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

How is the treatment in the Advanced Care Planning for Sarcoma trial different from other treatments?

This treatment is unique because it combines advanced care planning (ACP) with the administration of Temodar (a chemotherapy drug) and involves structured discussions and assessments to align treatment with patient values and goals, which is not typically part of standard sarcoma treatments. ^{1 2 3 4 5}

Research Team

Megan J Shen, PhD.

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

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

I am the chosen informal caregiver by the patient.

Patients must be English speaking

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

References

1. 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]

2. England 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. [2020]

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

Goals-of-care discussions. [2019]

4. United States 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. [2014]

5. England 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. [2021]