Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 11:29 PM
Study NCT ID:
NCT05388734
Status:
UNKNOWN
Last Update Posted:
2023-05-16
First Post:
2022-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shared Decision Making on Care Pathways and CAMs: A Pilot Study
Sponsor:
University Hospital, Grenoble
Organization:
Study Overview
Official Title:
Shared Decision Making on Care Pathways and CAMs: A Pilot Study
Status:
UNKNOWN
Status Verified Date:
2023-05
Last Known Status:
RECRUITING
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:
Shared Decision Making on Care Pathways and alternative and complementary medicine (CAMs) : A Pilot Study.
Study whose aim is to evaluate the feasibility of a study proposing a therapeutic education consultation leaning on the usual care pathway by estimating the recruitment capacity over 4 months as well as the acceptance rate of the study among patients diagnosed with breast cancer.
Study whose aim is to evaluate the feasibility of a study proposing a therapeutic education consultation leaning on the usual care pathway by estimating the recruitment capacity over 4 months as well as the acceptance rate of the study among patients diagnosed with breast cancer.
Detailed Description:
The use of alternative and complementary medicine (CAMs) has been steadily increasing for several years. Certain populations are more likely than others to use this type of care, including breast cancer patients, for whom the rate of use is close to 90%. However, these populations are those for whom the risks associated with this type of care are the highest. In addition, patients rarely discuss alternative and complementary medicine (CAMs) with conventional care teams. As a result, patients often place unreasonable expectations on alternative and complementary medicine (CAMs) and at the same time put themselves in risky situations.
The aim of this project is to help breast cancer patients better orient themselves in their care pathway and in particular with regard to the plethora of alternative and complementary medicine (CAMs) available. They could therefore make an informed decision to seek (or not) treatment. In order to reach a shared decision, a consultation will be offered to patients with the objective of discussing their past recourse, their knowledge of the care pathway, their fears and their aspirations with regard to alternative and complementary medicine (CAM). Epistemological concepts (self-efficacy, placebo, benefit-risk ratio, etc.) will be discussed in order to allow these elements to be transposed throughout their care.
The impact of this consultation on compliance with conventional treatment, satisfaction with the treatment as a whole and communication with the rest of the health care team will be evaluated. A before/after methodology will first allow us to evaluate the values taken by our judgement criteria in the usual care pathway and then in the innovative care pathway proposed by the intervention. This study will allow us to establish the feasibility of a future research project of larger scale.
The aim of this project is to help breast cancer patients better orient themselves in their care pathway and in particular with regard to the plethora of alternative and complementary medicine (CAMs) available. They could therefore make an informed decision to seek (or not) treatment. In order to reach a shared decision, a consultation will be offered to patients with the objective of discussing their past recourse, their knowledge of the care pathway, their fears and their aspirations with regard to alternative and complementary medicine (CAM). Epistemological concepts (self-efficacy, placebo, benefit-risk ratio, etc.) will be discussed in order to allow these elements to be transposed throughout their care.
The impact of this consultation on compliance with conventional treatment, satisfaction with the treatment as a whole and communication with the rest of the health care team will be evaluated. A before/after methodology will first allow us to evaluate the values taken by our judgement criteria in the usual care pathway and then in the innovative care pathway proposed by the intervention. This study will allow us to establish the feasibility of a future research project of larger scale.
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?: