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

Not Applicable

Not yet recruiting

• Conditions: Metastatic Sarcoma; Sarcoma
• Interventions: Behavioral: Assessment; Other: Questionnaire Administration; Other: Interview; Other: Electronic Health Record Review

• Registration Number: NCT05835154
• Lead Sponsor: Fred Hutchinson Cancer Center

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.

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 Timeline

• Study First Submitted: 2023-04-17
• Study First Submitted QC: 2023-04-27
• Study First Posted: 2023-04-28
• Status Verified: 2025-04
• Study Start: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-23
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive Care (advanced care planning checklist)	Questionnaire Administration	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.
Supportive Care (advanced care planning checklist)	Assessment	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.
Supportive Care (advanced care planning checklist)	Interview	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.
Supportive Care (advanced care planning checklist)	Electronic Health Record Review	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.

Primary Outcome Measures

Name	Time	Method
Feasibility, as measured by the number of subjects accrued to the study	At enrollment	The number of participants accrued during the recruitment period.
Feasibility, as measured by the number of subjects to complete the intervention	Through study completion, up to 4 weeks	The number of participants to complete the intervention.
Acceptability of the intervention: Acceptability E-Scale	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)	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	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 Outcome Measures

Name	Time	Method
Change in planning for mobility needs	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.
Change in functional status	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.
Change in discussion of advance directives	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).
Change in completion of advance directives	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.
Change in patients' engagement in clinical conversations (present/absent) with specialist providers	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.

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States