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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving Advance Care Planning Around Mobility Needs Among Patients With Sarcoma

Conditions
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Metastatic Sarcoma, Sarcoma

Intervention / Treatment
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* Behavioral: Assessment
* Other: Questionnaire Administration
* Other: Interview
* Other: Electronic Health Record Review


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive Care (advanced care planning checklist)<br>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<br>* Complete checklist<br>* Other names: Assess;Other: Questionnaire Administration<br>* Complete questionnaires<br>Other: Interview<br>* Undergo semi-structured feedback interview<br>Other: Electronic Health Record Review<br>* Review of medical records<br>|

What is the study measuring?
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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) |