Clinical trial NCT05388734: Shared Decision Making on Care Pathways and CAMs: A Pilot Study
Official title: Shared Decision Making on Care Pathways and CAMs: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Non-metastatic
Newly Diagnosed
Feasibility Study
Keywords: Complementary and Alternative Medicine (CAM)
breast cancer
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: University Grenoble Alps
name: Laboratoire TIMC-IMAG
First posted: 2022-05-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Quasi-experimental, before-and-after, comparative, prospective, single-center, open-label study.
Primary purpose: OTHER

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.

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.

Eligibility criteria: Inclusion Criteria:

* Patients recently diagnosed with breast cancer at Grenoble Alpes University Hospital
* In situ or invasive breast cancer, locally advanced but without metastasis, demonstrated on histology
* ECOG ( Eastern Cooperative Oncology Group) performance status 0, 1 or 2
* Cancer treated with chemotherapy, radiotherapy and/or surgery
* Having signed an informed consent after information, being of age and able to express consent, affiliated to a social security system

Exclusion Criteria:

* Pregnant, breastfeeding or parturient women
* women who do not speak French;
* patients participating in another research protocol
* Metastatic breast cancer, diagnosed psychiatric pathologies that make it impossible to perform the procedure, history of cancer except for cervical cancer in situ or basal cell cancer
* Subjects in a period of exclusion from another study,
* Subject under administrative or judicial supervision
* Subject unable to be contacted in case of emergency

Primary outcomes:
measure: Feasibility of a study proposing a therapeutic education consultation linked to the usual course of care
timeFrame: 8 month
Secondary outcomes:
measure: Evaluate literacy in the care pathway.
timeFrame: inclusion, 6 month
measure: Satisfaction with improvement in orientation to the care pathway
timeFrame: 6 month
measure: Success in orienting to the care pathway
timeFrame: inclusion, 6 month
measure: Assess satisfaction with the current care pathway
timeFrame: 6 month
measure: Collect the patient experience
timeFrame: 6 month
measure: To assess patient adherence, patient believes in the mechanics of TACs operation.
timeFrame: inclusion, 6 month
measure: To assess co-variance between oncologist and patient beliefs in TACs operating mechanisms
timeFrame: Inclusion
measure: To assess the use of TACs
timeFrame: inclusion, 6 month
measure: To assess satisfaction with TACs
timeFrame: inclusion, 6 month
measure: To assess satisfaction with oncology care.
timeFrame: 6 month
measure: Assess patient satisfaction with the procedure.
timeFrame: After intervention, 6 month
measure: Assess patient recommendation of the intervention
timeFrame: After intervention, 6 month
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Chu Grenoble
city: Saint-Martin-d'Hères
country: France
facility: Pole Sante Saint Martin D'Heres
Study officials:
affiliation: University Hospital, Grenoble
name: NICOLAS PINSAULT
role: PRINCIPAL_INVESTIGATOR
References: