Clinical trial NCT05835154: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Metastatic Sarcoma
Sarcoma
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility, as measured by the number of subjects accrued to the study
timeFrame: At enrollment
measure: Feasibility, as measured by the number of subjects to complete the intervention
timeFrame: Through study completion, up to 4 weeks
measure: Acceptability of the intervention: Acceptability E-Scale
timeFrame: After completion of intervention (+ 1 week)
measure: Usability: System Usability Scale (SUS)
timeFrame: After completion of intervention (+ 1 week)
measure: Acceptability: Satisfaction with the intervention
timeFrame: After completion of intervention (+ 1 week)
Secondary outcomes:
measure: Change in planning for mobility needs
timeFrame: From baseline to after completion of intervention (+ 1 week)
measure: Change in functional status
timeFrame: From baseline to after completion of intervention (+ 1 week)
measure: Change in patients' engagement in clinical conversations (present/absent) with specialist providers
timeFrame: From baseline to after completion of intervention (+ 1 week)
measure: Change in discussion of advance directives
timeFrame: From baseline to after completion of intervention (+ 1 week)
measure: Change in completion of advance directives
timeFrame: From baseline to after completion of intervention (+ 1 week)
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Megan Shen
role: PRINCIPAL_INVESTIGATOR
References: