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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sarcoma; Metastatic Sarcoma
• Intervention / Treatment: Other: Questionnaire Administration; Other: Electronic Health Record Review; Behavioral: Assessment; Other: Interview

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Megan Shen; Phone Number: 206-667-4172; Email: mshen2@fredhutch.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium
      • Contact: Megan Shen; Phone Number: 206-667-4172; Email: mshen2@fredhutch.org
      • Principal Investigator: Megan Shen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Questionnaire Administration; Complete questionnaires; Other: Electronic Health Record Review; Review of medical records; Behavioral: Assessment; Complete checklist; Other Names: Assess; Other: Interview; Undergo semi-structured feedback interview

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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).	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.	From baseline to after completion of intervention (+ 1 week)

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Investigators: Principal Investigator: Megan Shen, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: April 17, 2023
• First Submitted That Met QC Criteria: April 27, 2023
• First Posted (Actual): April 28, 2023

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma
• Other Study ID Numbers: RG1123026; 11174 (Fred Hutch/University of Washington Cancer Consortium); NCI-2022-09848 (Other Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No