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

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Primary Purpose

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Assessment

Questionnaire Administration

Interview

Electronic Health Record Review

About this trial

This is an interventional supportive care trial for Metastatic Sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Fred Hutch/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive Care (advanced care planning checklist)

Arm Description

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.

Outcomes

Primary Outcome Measures

Feasibility, as measured by the number of subjects accrued to the study

The number of participants accrued during the recruitment period.

Feasibility, as measured by the number of subjects to complete the intervention

The number of participants to complete the intervention.

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.

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.

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.

Secondary Outcome Measures

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.

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.

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.

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).

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.

Full Information

NCT ID

NCT05835154

First Posted

April 17, 2023

Last Updated

October 9, 2023

Sponsor

Fred Hutchinson Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT05835154

Brief Title

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

Official Title

Improving Advance Care Planning Around Mobility Needs Among Patients With Sarcoma

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 2024 (Anticipated)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fred Hutchinson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Sarcoma, Sarcoma

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Supportive Care (advanced care planning checklist)

Arm Type

Experimental

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Assessment

Other Intervention Name(s)

Assess

Intervention Description

Complete checklist

Intervention Type

Other

Intervention Name(s)

Questionnaire Administration

Intervention Description

Complete questionnaires

Intervention Type

Other

Intervention Name(s)

Interview

Intervention Description

Undergo semi-structured feedback interview

Intervention Type

Other

Intervention Name(s)

Electronic Health Record Review

Intervention Description

Review of medical records

Primary Outcome Measure Information:

Title

Feasibility, as measured by the number of subjects accrued to the study

Description

The number of participants accrued during the recruitment period.

Time Frame

At enrollment

Title

Feasibility, as measured by the number of subjects to complete the intervention

Description

The number of participants to complete the intervention.

Time Frame

Through study completion, up to 4 weeks

Title

Acceptability of the intervention: Acceptability E-Scale

Description

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.

Time Frame

After completion of intervention (+ 1 week)

Title

Usability: System Usability Scale (SUS)

Description

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.

Time Frame

After completion of intervention (+ 1 week)

Title

Acceptability: Satisfaction with the intervention

Description

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.

Time Frame

After completion of intervention (+ 1 week)

Secondary Outcome Measure Information:

Title

Change in planning for mobility needs

Description

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.

Time Frame