Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-09848 | Other Identifier | CTRP (Clinical Trial Reporting Program) | |
| 11174 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive Care (advanced care planning checklist) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assessment | Behavioral | Complete checklist |
|
| 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) |
| 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) |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Megan Shen | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 12, 2025 | May 8, 2026 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D012149 | Restraint, Physical |
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Questionnaire Administration | Other | Complete questionnaires |
|
| Interview | Other | Undergo semi-structured feedback interview |
|
| Electronic Health Record Review | Other | Review of medical records |
|
| 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) |
| D003625 |
| Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |