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.
12345Eligibility 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
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Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Supportive Care (advanced care planning checklist)Experimental Treatment4 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Fred Hutch/University of Washington Cancer ConsortiumSeattle, WA
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Who Is Running the Clinical Trial?
Fred Hutchinson Cancer CenterLead Sponsor
References
If We Don't Ask, Our Patients Might Never Tell: The Impact of the Routine Use of a Patient Values Assessment. [2018]Good communication can be associated with better end-of-life outcomes. The US Oncology Network developed and tested a Values Assessment (VA) for facilitating advance care planning (ACP). The results of the first 1,268 patients are reported.
Advance care planning for vulnerable older adults within an Accountable Care Organization: study protocol for the IMPACT randomised controlled trial. [2020]Patients with multimorbidity plus additional impairments (eg, mobility limitations, disability, cognitive impairments or frailty) are at the highest risk for poor healthcare outcomes. Advanced care planning (ACP) provides patients and their surrogates the opportunity to discuss their goals, values and priorities for healthcare-particularly in the context of end-of-life care. ACP discussions promote more person-centred care; however, it is currently underused. There is a tremendous need for systematic, scalable approaches to individualised ACP that promotes patient and family engagement. Here we describe the study protocol for a randomised effectiveness trial of a nurse navigator and informatics intervention designed to improve the documentation and quality of ACP discussions.
Goals-of-care discussions. [2019]Goals-of-care conversations led by the oncologist are key to advancing the prognostic awareness of the patient and family, but too frequently do not occur or are ineffective in leading to advance care planning and appropriate planning for end-of-life care. At our institution, a phase 3 trial of palliative care added to usual care of phase 1 clinical trial patients gave us the opportunity to develop an electronic medical record-based goals-of-care template for discussions. We can complete all or parts of the form with patients, use it to ensure full coverage of important tasks such as planning for transition to hospice and legacy work, and make sure all the providers are "on the same page" about treatment plans. We have this within our EMR as a SmartPhrase that can be brought up for completion, and have found that it helps to clarify patient understanding. The form can also be used to document advance care planning for both clinical care and billing. Although this tool has not been formally tested, we have found that it is effective in day-to-day practice as well as in research, and we share it here.
Advance care planning in patients with cancer referred to a phase I clinical trials program: the MD Anderson Cancer Center experience. [2014]Patients with advanced malignancies referred for early clinical trials have a short life expectancy. We designed this survey to ascertain the status of advance care planning in this population.
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]Advance care planning (ACP) is associated with improved health outcomes for patients with cancer, and its absence is associated with unfavourable outcomes for patients and their caregivers. However, older adults do not complete ACP at expected rates due to patient and clinician barriers. We present the original design, methods and rationale for a trial aimed at improving ACP for older patients with advanced cancer and the modified protocol in response to changes brought by the COVID-19 pandemic.