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

NCT05835154 | Recruiting

• 3 other identifiers: RG1123026NCI-2022-0984811174
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sarcoma; Metastatic Sarcoma

Outcome Measures

Primary Outcomes (5)

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

  The number of participants accrued during the recruitment period.

  At enrollment

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

  The number of participants to complete the intervention.

  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.

  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.

  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.

  After completion of intervention (+ 1 week)

Secondary Outcomes (5)

• Change in planning for mobility needs

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

• Change in functional status

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

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

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

• Change in discussion of advance directives

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

• Change in completion of advance directives

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

Study Arms (1)

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.

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

Interventions

Assessment BEHAVIORAL

Complete checklist

Also known as: Assess

Supportive Care (advanced care planning checklist)

Questionnaire Administration OTHER

Complete questionnaires

Supportive Care (advanced care planning checklist)

Interview OTHER

Undergo semi-structured feedback interview

Supportive Care (advanced care planning checklist)

Electronic Health Record Review OTHER

Review of medical records

Supportive Care (advanced care planning checklist)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Conditions

Sarcoma

Interventions

Restraint, Physical; Interviews as Topic

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Megan Shen

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Shen

CONTACT

206-667-4172; mshen2@fredhutch.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: April 28, 2023
• Study Start: July 8, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)