Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06326554
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-03-15
Brief Title:
Pilot Trial of Virtual and In-person STEP2
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Single Arm Pilot Trial of Virtual and In-person Symptom Screening With Targeted Early Palliative Care STEP2
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEP2
Brief Summary:
The goal of this clinical trial is to assess the feasibility of offering oncology patients a referral to the outpatient palliative care clinic based on virtual symptom screening before oncology clinic appointments and to qualitatively explore factors patients consider when deciding to accept or defer a visit to this clinic
Participants will be asked to complete questionnaires assessing quality of life symptom burden depression anxiety and satisfaction with care at baseline 2 4 and 6 months
Participants will be asked to complete questionnaires assessing quality of life symptom burden depression anxiety and satisfaction with care at baseline 2 4 and 6 months
Detailed Description:
To improve equitable access to early palliative care based on symptom severity the investigators developed Symptom screening with Targeted Early Palliative care STEP and demonstrated its feasibility in a previous trial STEP was designed and tested before the COVID-19 pandemic and was based on symptom screening using tabletscomputers in oncology clinics and in-person visits in the palliative care clinic In response to changes in hospital care as a result of the COVID-19 pandemic the investigators developed a novel mixed in-person and virtually delivered intervention STEP2
The investigators propose to test STEP2 in a single-arm pilot trial enrolling outpatients with advanced cancer and a prognosis of 6 months to 3 years Participants will complete the Edmonton Symptom Assessment System-revised ESAS-r tool electronically before oncology appointments as is usual care in Ontario Canada in addition if patients report moderate to high symptom scores they will receive nurse-led triage and targeted referral to specialized palliative care Quality of life symptom burden depression anxiety and satisfaction with care will be assessed at baseline 2 4 and 6 months using questionnaires
The objectives of this study are 1 to assess the feasibility of the STEP2 intervention including completion of virtual symptom screening before oncology clinic appointments and completing triggered palliative care visits by video as well as in person and 2 to explore factors patients consider when deciding to accept or defer a visit to the outpatient palliative care clinic
The investigators propose to test STEP2 in a single-arm pilot trial enrolling outpatients with advanced cancer and a prognosis of 6 months to 3 years Participants will complete the Edmonton Symptom Assessment System-revised ESAS-r tool electronically before oncology appointments as is usual care in Ontario Canada in addition if patients report moderate to high symptom scores they will receive nurse-led triage and targeted referral to specialized palliative care Quality of life symptom burden depression anxiety and satisfaction with care will be assessed at baseline 2 4 and 6 months using questionnaires
The objectives of this study are 1 to assess the feasibility of the STEP2 intervention including completion of virtual symptom screening before oncology clinic appointments and completing triggered palliative care visits by video as well as in person and 2 to explore factors patients consider when deciding to accept or defer a visit to the outpatient palliative care clinic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None