Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-25 @ 4:45 PM
Study NCT ID:
NCT03045003
Status:
COMPLETED
Last Update Posted:
2017-02-09
First Post:
2017-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Testing Two Different Intensities of an Intervention to Enhance REsilience and to Reduce SupportIve Care Needs in Cancer Patients
Sponsor:
Manuela Eicher
Organization:
Study Overview
Official Title:
Testing the Feasibility and Efficacy of Two Different Intensities of an Intervention to Enhance REsilience and to Reduce SupportIve Care Needs in Cancer Patients: A Phase II TriaL
Status:
COMPLETED
Status Verified Date:
2017-02
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:
RESIL
Brief Summary:
The aim of this phase II study is to test by feasibility and efficacy of two interprofessional supportive care interventions with different intensities to facilitate resilience in patients and thereby to reduce their unmet supportive care needs.
Detailed Description:
Intervention A (tested in arm A) includes screening of resilience and supportive care needs as well as direct feed-back of the screening results on a monitoring sheet to nurses and oncologists in charge of the patient. Nurses and oncologists follow three training sessions to be trained in a) resilience facilitation, b) interventions to adress supportive care needs, c) use of the monitoring sheet.
Intervention B (tested in arm B) includes same intervention as arm A supplemented by 5 structured nurse led consultations, two face to face (F2F), three by phone (PC) provided by clinical nurse specialists and based on a consultation manual.
Intervention B (tested in arm B) includes same intervention as arm A supplemented by 5 structured nurse led consultations, two face to face (F2F), three by phone (PC) provided by clinical nurse specialists and based on a consultation manual.
Study Oversight
Has Oversight DMC:
False
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?: