Metastatic SarcomaNCT05835154
A Checklist (Advanced Care Planning) for The Assessment of Mobility Needs in Patients With Sarcoma
A study testing Assessment, Questionnaire Administration and Interview in people with Metastatic Sarcoma and Sarcoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metastatic Sarcoma, Sarcoma
- What is being tested?
- Assessment, Questionnaire Administration and Interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2025to 3 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PATIENTS: Age 18 years of age or older.
- PATIENTS: English speaking
- PATIENTS: Able to provide informed consent
- PATIENTS: Have access to a computer or other device to fill out the online checklist
- PATIENTS: Have had either limb salvage or amputation surgery for sarcoma within the last 6 months OR have metastatic (stage IV) sarcoma and are in active treatment.
- CAREGIVERS: Age 18 years of age or older
Show all 10Show fewer
- CAREGIVERS: English speaking
- CAREGIVERS: Able to provide informed consent
- CAREGIVERS: Have access to a computer or other device to fill out the online checklist
- CAREGIVERS: The person (family member or friend) whom the patient indicates being an informal caregiver
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Improving Advance Care Planning Around Mobility Needs Among Patients With Sarcoma
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.
Read the detailed description
OUTLINE:
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.
- Conditions
- Metastatic Sarcoma, Sarcoma
- Being tested
- Assessment, Questionnaire Administration, Interview, Electronic Health Record Review
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentBehavioural
Also called Assess
Complete checklist
Questionnaire AdministrationOther
Complete questionnaires
InterviewOther
Undergo semi-structured feedback interview
Electronic Health Record ReviewOther
Review of medical records
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (advanced care planning checklist) | Experimental | 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. Receives: Behavioral: Assessment; Other: Questionnaire Administration; Other: Interview; Other: Electronic Health Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility, as measured by the number of subjects accrued to the study
The number of participants accrued during the recruitment period.
Measured: At enrollment
Feasibility, as measured by the number of subjects to complete the intervention
The number of participants to complete the intervention.
Measured: Through study completion, up to 4 weeks
Acceptability of the intervention: Acceptability E-Scale
The Acceptability E-Scale is a 6-item scale, scored on a 5-point Likert scale (e.g., 1=very difficult; 5= very easy), with previously demonstrated good internal consistency (Cronbach's alpha=.76), with higher values indicating higher levels of acceptability.
Measured: After completion of intervention (+ 1 week)
Usability: System Usability Scale (SUS)
Usability of the ACP Mobility Checklist will be assessed among patients using the System Usability Scale (SUS). The SUS is a 10-item scale, scored on a 5-point Likert scale (1=strongly disagree; 5=strongly agree), with higher values indicating higher levels of usability.
Measured: After completion of intervention (+ 1 week)
Acceptability: Satisfaction with the intervention
Satisfaction with the intervention will be assessed with a single, 10-point Likert scale item assessing how satisfied participants are with the intervention (1= not at all satisfied, 10 = extremely satisfied). Higher values indicate higher ratings of satisfaction.
Measured: After completion of intervention (+ 1 week)
Secondary outcomes (5)
Change in planning for mobility needs
Will be measured by asking participants seven items about what mobility needs they have planned for (e.g., assistance with home environment, toileting, dressing, etc.) (yes/no). Total scores can range from 0 to 7, with higher values indicating higher rates of understanding and awareness.
Measured: From baseline to after completion of intervention (+ 1 week)
Change in functional status
Functional status will be measured using the PROMIS Cancer Function Brief, which is a validated 12-item scale scored on a 5-point Likert scale, with higher scores indicating better functioning.
Measured: From baseline to after completion of intervention (+ 1 week)
Change in patients' engagement in clinical conversations (present/absent) with specialist providers
Engagement in clinical conversations (present/absent) with providers will be measured with four questions asking patients if they have had an interaction or consult with a physical therapist, occupational therapist, speech language pathologist, and/or rehabilitation physician (yes/no). Total scores can range from 0 to 4, with higher values indicating higher rates of engagement in clinical conversations with specialist providers.
Measured: From baseline to after completion of intervention (+ 1 week)
Change in discussion of advance directives
This will be measured using our previously utilized 8-item measure of discussing end-of-life care, living will, healthcare proxy, and do-not-resuscitate orders with family and doctor (all yes/no questions).
Measured: From baseline to after completion of intervention (+ 1 week)
Change in completion of advance directives
This will be assessed by asking patients whether they have completed a Do Not Resuscitate order (DNR), living will, or identified a Health Care Proxy (HCP). All yes/no questions.
Measured: From baseline to after completion of intervention (+ 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start8 Jul 2025
- Primary completion3 Apr 2026
- Study completion3 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic SarcomaStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Megan Shen, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835154
- Sponsor's protocol ID
- RG1123026
- Other IDs
- NCI-2022-09848, 11174
- Status last verified
- May 2026
- First submitted
- 17 Apr 2023
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Advance Care Planning Around Mobility Needs Among Patients With Sarcoma
- ClinicalTrials.gov ID
- NCT05835154
- Acronym / sponsor ID
- RG1123026
- Conditions
- Metastatic Sarcoma, Sarcoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- 3 Apr 2026 (actual)
- Study completion
- 3 Apr 2026 (actual)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OUTLINE:
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (advanced care planning checklist) | Experimental | Behavioral: Assessment, Other: Questionnaire Administration, Other: Interview, Other: Electronic Health Record ReviewFIELD 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- PATIENTS: Age 18 years of age or older.
- PATIENTS: English speaking
- PATIENTS: Able to provide informed consent
- PATIENTS: Have access to a computer or other device to fill out the online checklist
- PATIENTS: Have had either limb salvage or amputation surgery for sarcoma within the last 6 months OR have metastatic (stage IV) sarcoma and are in active treatment.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AssessmentAlso: AssessComplete checklist | Behavioural | Supportive Care (advanced care planning checklist) |
| Questionnaire AdministrationComplete questionnaires | Other | Supportive Care (advanced care planning checklist) |
| InterviewUndergo semi-structured feedback interview | Other | Supportive Care (advanced care planning checklist) |
| Electronic Health Record ReviewReview of medical records | Other | Supportive Care (advanced care planning checklist) |
Primary outcome
Feasibility, as measured by the number of subjects accrued to the study
Time frame: At enrollment
The number of participants accrued during the recruitment period.
Feasibility, as measured by the number of subjects to complete the intervention
Time frame: Through study completion, up to 4 weeks
The number of participants to complete the intervention.
Acceptability of the intervention: Acceptability E-Scale
Time frame: After completion of intervention (+ 1 week)
The Acceptability E-Scale is a 6-item scale, scored on a 5-point Likert scale (e.g., 1=very difficult; 5= very easy), with previously demonstrated good internal consistency (Cronbach's alpha=.76), with higher values indicating higher levels of acceptability.
Usability: System Usability Scale (SUS)
Time frame: After completion of intervention (+ 1 week)
Usability of the ACP Mobility Checklist will be assessed among patients using the System Usability Scale (SUS). The SUS is a 10-item scale, scored on a 5-point Likert scale (1=strongly disagree; 5=strongly agree), with higher values indicating higher levels of usability.
Acceptability: Satisfaction with the intervention
Time frame: After completion of intervention (+ 1 week)
Satisfaction with the intervention will be assessed with a single, 10-point Likert scale item assessing how satisfied participants are with the intervention (1= not at all satisfied, 10 = extremely satisfied). Higher values indicate higher ratings of satisfaction.
5 secondary outcomes
Change in planning for mobility needs
Time frame: From baseline to after completion of intervention (+ 1 week)
Change in functional status
Time frame: From baseline to after completion of intervention (+ 1 week)
Change in patients' engagement in clinical conversations (present/absent) with specialist providers
Time frame: From baseline to after completion of intervention (+ 1 week)
Change in discussion of advance directives
Time frame: From baseline to after completion of intervention (+ 1 week)
Change in completion of advance directives
Time frame: From baseline to after completion of intervention (+ 1 week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan Shen principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment, Questionnaire Administration and Interview in people with Metastatic Sarcoma and Sarcoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility, as measured by the number of subjects accrued to the study (time frame: At enrollment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.