Shared Decision Making on Care Pathways and CAMs: A Pilot Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-28

Study Completion Date

2024-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer Non-metastatic Newly Diagnosed Feasibility Study

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Quasi-experimental, before-and-after, comparative, prospective, single-center, open-label study.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Before group

Patients in the before group are recruited during the first 4 months of the study and will not benefit from the alternative medicine education consultation

Group Type NO_INTERVENTION

No interventions assigned to this group

After Group

Patients in the front group are recruited from the 5th month of the study and will benefit from the alternative medicine education consultation

Group Type ACTIVE_COMPARATOR

alternative medicine education consultation

Intervention Type OTHER

The intervention will consist in a 1h30 individual consultation with a GP physician. Patients will be able to ask any questions they have regarding treatments for their breast cancer delivered outside of the hospital. Topics such as benefit-risk ratios, placebo effects and expectancies from CAM will be discussed with the patients. This consultation will promote a shared-decision model to help patients better discuss these matters with their healthcare providers.

Interventions

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alternative medicine education consultation

The intervention will consist in a 1h30 individual consultation with a GP physician. Patients will be able to ask any questions they have regarding treatments for their breast cancer delivered outside of the hospital. Topics such as benefit-risk ratios, placebo effects and expectancies from CAM will be discussed with the patients. This consultation will promote a shared-decision model to help patients better discuss these matters with their healthcare providers.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes