Metastatic Sarcoma, Sarcoma
Conditions
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.
Interventions
BEHAVIORALAssessment
Complete checklist
OTHERQuestionnaire Administration
Complete questionnaires
OTHERInterview
Undergo semi-structured feedback interview
OTHERElectronic Health Record Review
Review of medical records
Sponsors
Fred Hutchinson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMegan Shen
Fred Hutch/University of Washington Cancer Consortium
Outcome results
None listed