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CompletedNCT05835154Updated May 12, 2026

A Checklist (Advanced Care Planning) for The Assessment of Mobility Needs in Patients With Sarcoma

An interventional study of Assessment and Questionnaire Administration in Metastatic Sarcoma and Sarcoma, sponsored by Fred Hutchinson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-12.

Sponsored by Fred Hutchinson Cancer Center · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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. 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.

02

Conditions studied

  • Metastatic Sarcoma
  • Sarcoma

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03

In context

Sarcoma

1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.

This study's enrollment of 27 is below the median of 40 across 1,283 interventional studies indexed under Sarcoma.

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Lead sponsor

Fred Hutchinson Cancer Center is the lead sponsor of 537 studies on the registry; 79 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 45 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    Supportive Care (advanced care planning checklist)

    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.

    Behavioral: Assessment · Other: Questionnaire Administration · Other: Interview · Other: Electronic Health Record Review

Interventions

  • BehavioralAssessment

    Complete checklist

    Also known as: Assess

  • OtherQuestionnaire Administration

    Complete questionnaires

  • OtherInterview

    Undergo semi-structured feedback interview

  • OtherElectronic Health Record Review

    Review of medical records

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What researchers measure

Primary outcomes

  1. Feasibility, as measured by the number of subjects accrued to the study

    The number of participants accrued during the recruitment period.

    Time frame: At enrollment

  2. Feasibility, as measured by the number of subjects to complete the intervention

    The number of participants to complete the intervention.

    Time frame: Through study completion, up to 4 weeks

  3. 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.

    Time frame: After completion of intervention (+ 1 week)

  4. 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.

    Time frame: After completion of intervention (+ 1 week)

  5. 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.

    Time frame: After completion of intervention (+ 1 week)

Secondary outcomes

  1. 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.

    Time frame: From baseline to after completion of intervention (+ 1 week)

  2. 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.

    Time frame: From baseline to after completion of intervention (+ 1 week)

  3. 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.

    Time frame: From baseline to after completion of intervention (+ 1 week)

  4. 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).

    Time frame: From baseline to after completion of intervention (+ 1 week)

  5. 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.

    Time frame: From baseline to after completion of intervention (+ 1 week)

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Study locations

1 site
  • Fred Hutch/University of Washington Cancer Consortium
    Seattle, Washington 98109, United States
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References and documents

Study documents

  • Informed consent form · Jun 12, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05835154
Lead sponsor
Fred Hutchinson Cancer Center
Responsible party
Sponsor
First posted
Apr 28, 2023
Start date
Jul 8, 2025
Primary completion
Apr 3, 2026
Completion
Apr 3, 2026
Last update
May 12, 2026

Study contacts

Megan Shen
principal investigator · Fred Hutch/University of Washington Cancer Consortium

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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