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Completed

NCT Number: NCT05835154

A Checklist (Advanced Care Planning) for The Assessment of Mobility Needs in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assessment

Behavioral

Complete checklist

Other names: Assess

Questionnaire Administration

Other

Complete questionnaires

interview

Other

Undergo semi-structured feedback interview

Electronic Health Record Review

Other

Review of medical records

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Change in planning for mobility needs

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

    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.

  2. Change in functional status

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

    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.

  3. Change in patients' engagement in clinical conversations (present/absent) with specialist providers

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

    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.

  4. Change in discussion of advance directives

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

    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).

  5. Change in completion of advance directives

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

    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.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Registry information

Official study title

Improving Advance Care Planning Around Mobility Needs Among Patients With Sarcoma

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 28, 2023
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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