Ignite Creation Date:
2024-05-06 @ 2:05 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04208490
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2019-12-04
Brief Title:
Implementation and Effectiveness Trial of HN-STAR
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Implementation and Effectiveness Trial of HN-STAR
Status:
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:
HN-STAR
Brief Summary:
People who have been treated for head and neck cancer HNC survivors can experience serious consequences from their cancer and its treatment ongoing risks of new cancers and other unrelated illnesses These concerns pose challenges to the provision of comprehensive care to HNC survivors We created HN-STAR to facilitate and tailor the ongoing care of HNC survivors Survivors use HN-STAR on a computer or tablet to answer questions about symptoms and health concerns before a routine visit with a cancer care provider During the clinic visit the provider uses HN-STAR to see evidence-based recommendations for managing each concern reported by the survivor The provider and survivor discuss recommendations and select appropriate actions eg testing referrals prescriptions self-management HN-STAR produces a survivorship care plan that includes all reported concerns and the actions selected in clinic The survivorship care plan is given to the survivor and the primary care provider Three months six months and nine months later the survivor uses HN-STAR from home or clinic to report their concerns again and a new survivorship care plan is created each time
Our trial randomizes 20-36 oncology practices from the National Community Oncology Research Program to use HN-STAR or provide usual care to 298-400 recent survivors of head and neck cancer We hypothesize that survivors in the HN-STAR arm will have greater improvement in patient-centered outcomes including cancer-related well-being symptoms and patient activation over one year compared to survivors in the usual care arm measured by surveys at baseline and one year later We also hypothesize that survivors in the HN-STAR arm will be more likely to receive care that is aligned with evidence-based recommendations during the year of the study than survivors in the usual care arm Our final aim investigates the implementation of HN-STAR in clinical practice using interviews and surveys of survivors providers and other clinic staff to understand the feasibility acceptability appropriateness and other aspects of providing survivorship care to head and neck cancer survivors
Our trial randomizes 20-36 oncology practices from the National Community Oncology Research Program to use HN-STAR or provide usual care to 298-400 recent survivors of head and neck cancer We hypothesize that survivors in the HN-STAR arm will have greater improvement in patient-centered outcomes including cancer-related well-being symptoms and patient activation over one year compared to survivors in the usual care arm measured by surveys at baseline and one year later We also hypothesize that survivors in the HN-STAR arm will be more likely to receive care that is aligned with evidence-based recommendations during the year of the study than survivors in the usual care arm Our final aim investigates the implementation of HN-STAR in clinical practice using interviews and surveys of survivors providers and other clinic staff to understand the feasibility acceptability appropriateness and other aspects of providing survivorship care to head and neck cancer survivors
Detailed Description:
None
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 |
|---|---|---|---|
| 5UG1CA189824 | NIH | WF NCORP RB | httpsreporternihgovquickSearch5UG1CA189824 |
| NCI-2019-03600 | REGISTRY | None | None |
| WF-1805CD | OTHER | None | None |