20 Participants Needed

Advanced Care Planning for Sarcoma

Megan J Shen, PhD. profile photo
Overseen ByMegan J Shen, PhD.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Fred Hutchinson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.12345

Who Is on the Research Team?

Megan J. Shen, PhD - Associate ...

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 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
See 4 more

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?
1Treatment groups
Experimental Treatment
Group I: Supportive Care (advanced care planning checklist)Experimental Treatment4 Interventions

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

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Approved in United States as Temodar for:
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Approved in European Union as Temodal for:

Find a Clinic Near You

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

Citations

If We Don't Ask, Our Patients Might Never Tell: The Impact of the Routine Use of a Patient Values Assessment. [2018]
Advance care planning for vulnerable older adults within an Accountable Care Organization: study protocol for the IMPACT randomised controlled trial. [2020]
Goals-of-care discussions. [2019]
Advance care planning in patients with cancer referred to a phase I clinical trials program: the MD Anderson Cancer Center experience. [2014]
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]
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