Ignite Creation Date:
2024-05-06 @ 11:12 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03464188
Status:
COMPLETED
Last Update Posted:
2021-05-27
First Post:
2018-03-01
Brief Title:
An Upstream Palliative Care Intervention for Rural and African-American Advanced Cancer Family Caregivers
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
An Upstream Palliative Care Intervention for Rural Family Caregivers
Status:
COMPLETED
Status Verified Date:
2021-05
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:
None
Brief Summary:
The burden placed on advanced cancer family caregivers FCGs and the toll on their mental and physical health have never been greater and is particularly pernicious for underserved groups in the Southeastern US including rural-dwellers and African-Americans for whom interventions have not been specifically developed and tested The purpose of this K99R00 is provide the awardee with the knowledge and training necessary to become a leading independent clinical investigator in developing and testing telehealth palliative care interventions for family caregivers FCGs of underserved persons with advanced cancer The research specific aim during the K99 phase was to develop and tailor the content format and delivery of a telehealth intervention for FCGs of persons with advanced cancer in the rural South To meet this aim qualitative semi-structured interviews were conducted with 26 lay healthcare navigators 20 FCGs and 18 patients with advanced cancer to elicit feedback on a FCG intervention outline based on published evidence-based interventions After thematic analysis major findings included that the intervention should have topical content that is flexible and based on continuous assessment include at least some face-to-face contact cautiously consider internet-based technologies because internet access in rural areas is poor and potentially have navigators lead the intervention with appropriate oversight and additional training K99 study findings have been used to adapt and develop a potentially scalable FCG intervention in the Southern US population Project Cornerstone The K99 study phase in combination with accomplishing the training objectives has successfully catalyzed the awardees transition from a Postdoctoral Fellow to a Tenure-Track Assistant Professor at the University of Alabama at Birmingham School of Nursing The overall goal during the R00 phase will be to conduct a small-scale pilot RCT of Cornerstone with 70 FCGs of rural-dwelling andor African-American patients with advanced cancer to assess acceptability feasibility and potential efficacy The research specific aims during the R00 phase are to evaluate the acceptability of Cornerstone and the feasibility of enrolling and retaining 70 participants into a RCT of the FCG intervention for 24 weeks Aim 1 and evaluate the potential efficacy of Cornerstone in improving caregiver Aim 2 and care recipient Aim 3 outcomes compared to usual care quality of life and distress anxietydepressive symptoms The results will directly support an R-01 application to conduct an efficacy RCT of an early telehealth PC intervention for Southern FCGs of underserved persons with advanced cancer
Detailed Description:
Enrollment goal was increased from 60 to 70 participants due to attrition
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