Ignite Creation Date:
2024-05-06 @ 8:05 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02668575
Status:
COMPLETED
Last Update Posted:
2020-02-18
First Post:
2016-01-14
Brief Title:
Integrating Supportive Care in Cystic Fibrosis
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Integrating Supportive Care in Cystic Fibrosis A Pilot Study
Status:
COMPLETED
Status Verified Date:
2020-02
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:
Individuals living with cystic fibrosis CF commonly report high symptom burden poor quality of life and additional psychosocial stressors these burdens are particularly heightened in advanced stages of the disease Although supportive care aka palliative care has been shown to improve many of these outcomes among patients with illnesses such as cancer no clinical trials to date have tested the impact of supportive care for patients with CF The purpose of this pilot randomized clinical trial study is to evaluate the feasibility acceptability and perceived effectiveness of an embedded supportive care intervention whereby a supportive care specialist will be integrated within the usual care experience of patients with advanced CF The investigators will enroll 50 patients with advanced CF who will be equally randomized to receive this embedded supportive care intervention or usual care Secondary measures include patient quality of life mood coping style satisfaction with care and symptom burden This study will provide preliminary data to support the development of a larger definitive Phase III randomized clinical trial
Detailed Description:
As described above
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None