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

Sarcoma Clinical Trial

Official title:

Improving Advance Care Planning Around Mobility Needs Among Patients With Sarcoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05835154
• Other study ID #: RG1123026
• Secondary ID: NCI-2022-0984811
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: November 30, 2024

Study information

• Verified date: May 2024
• Source: Fred Hutchinson Cancer Center
• Contact: Megan Shen
• Phone: 206-667-4172
• Email: mshen2[@]fredhutch.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: November 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Sarcoma
• Sarcoma

Intervention

Behavioral:
• Assessment
Complete checklist

Other:
• Questionnaire Administration
Complete questionnaires
• Interview
Undergo semi-structured feedback interview
• Electronic Health Record Review
Review of medical records

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility, as measured by the number of subjects accrued to the study	The number of participants accrued during the recruitment period.	At enrollment
Primary	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
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)