Ignite Creation Date:
2024-05-06 @ 7:32 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06044441
Status:
RECRUITING
Last Update Posted:
2024-01-05
First Post:
2023-08-30
Brief Title:
Evaluation and Implementation Preparation of a Proactive Palliative Care Model ENABLE-SG
Sponsor:
National Cancer Centre Singapore
Organization:
National Cancer Centre Singapore
Study Overview
Official Title:
ENABLE-SG Educate Nurture Advise Before Life Ends for Singapore as a Proactive Palliative Care Model Evaluation and Implementation Preparation
Status:
RECRUITING
Status Verified Date:
2024-01
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:
ENABLE-SG
Brief Summary:
The current interdisciplinary specialist palliative care model focuses on supporting patients with advanced cancer who have complex problems in the last weeks of life Consequently palliative care is often provided late and in response to uncontrolled symptoms during crises Palliative care models should shift from this reactionary illness-stress paradigm to a proactive health-wellness approach that is integrated early in the patients disease trajectory
A proactive early palliative care telehealth model ENABLE Educate Nurture Advise Before Life Ends was developed in the US to coach patients with advanced cancers and their family caregivers on how to cope effectively with serious illness By empowering individuals early before acute distress and symptoms occur patients and families can better mitigate and avoid crises Building on positive health outcomes demonstrated by the ENABLE model in the US the study team has successfully pilot-tested a culturally adapted ENABLE-SG model in Singapore This study seeks to test the effectiveness of this ENABLE-SG model among patients with recently diagnosed advanced cancer and their caregivers while simultaneously collecting data on real-world implementation
A proactive early palliative care telehealth model ENABLE Educate Nurture Advise Before Life Ends was developed in the US to coach patients with advanced cancers and their family caregivers on how to cope effectively with serious illness By empowering individuals early before acute distress and symptoms occur patients and families can better mitigate and avoid crises Building on positive health outcomes demonstrated by the ENABLE model in the US the study team has successfully pilot-tested a culturally adapted ENABLE-SG model in Singapore This study seeks to test the effectiveness of this ENABLE-SG model among patients with recently diagnosed advanced cancer and their caregivers while simultaneously collecting data on real-world implementation
Detailed Description:
To evaluate the effectiveness of the ENABLE-SG model we will conduct a randomized wait-list controlled trial comparing clinical outcomes at 6 months between patients and caregivers receiving early ENABLE-SG and their wait-listed counterparts receiving usual care Eligible patients and their caregivers will be randomly assigned at baseline to receive ENABLE-SG either immediately or after a 6-month waiting period To evaluate ways to improve implementation the Consolidated Framework for Implementation Research CFIR will be used to systematically identify processes that influence implementation outcomes
The specific aims and hypotheses of this study are
1 Assess the effectiveness of ENABLE-SG among patients with advanced cancer We hypothesize that at 6 months compared to usual care patients who received ENABLE-SG will have better health-related quality of life QoL mood health status coping strategies lesser palliative care concerns lesser acute healthcare utilisation and smaller hospital bill size At 12 months compared to wait-list control group early ENABLE-SG recipients will have better primary and secondary outcomes
2 Assess the effectiveness of ENABLE-SG among caregivers of patients with advanced cancer We hypothesize that at 6 months compared to usual care caregivers who received ENABLE-SG will have better caregiver health-related QoL mood coping strategies satisfaction with care and lower caregiving costs At 12 months compared to wait-list control group early ENABLE-SG recipients will have better primary and secondary outcomes
3 Assess ways to improve ENABLE-SG implementation in the real-world context
The specific aims and hypotheses of this study are
1 Assess the effectiveness of ENABLE-SG among patients with advanced cancer We hypothesize that at 6 months compared to usual care patients who received ENABLE-SG will have better health-related quality of life QoL mood health status coping strategies lesser palliative care concerns lesser acute healthcare utilisation and smaller hospital bill size At 12 months compared to wait-list control group early ENABLE-SG recipients will have better primary and secondary outcomes
2 Assess the effectiveness of ENABLE-SG among caregivers of patients with advanced cancer We hypothesize that at 6 months compared to usual care caregivers who received ENABLE-SG will have better caregiver health-related QoL mood coping strategies satisfaction with care and lower caregiving costs At 12 months compared to wait-list control group early ENABLE-SG recipients will have better primary and secondary outcomes
3 Assess ways to improve ENABLE-SG implementation in the real-world context
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HCSAINV23jan-0001 | OTHER_GRANT | NMRC - HPHSR Clinician Scientist Award HCSA | None |