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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05388734
• Other study ID #: 2021-A03027-34
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2022
• Est. completion date: August 2024

Study information

• Verified date: May 2023
• Source: University Hospital, Grenoble
• Contact: NICOLAS PINSAULT
• Phone: 0476765040
• Email: Npinsault[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Feasibility Study
• Newly Diagnosed
• Non-metastatic

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Chu Grenoble	Grenoble
France	Pole Sante Saint Martin D'Heres	Saint-Martin-d'Hères

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Laboratoire TIMC-IMAG, University Grenoble Alps

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of a study proposing a therapeutic education consultation linked to the usual course of care	The investigators wish know the recruitment capacity in this study. To do this, the investigators will estimate the number of people included over 8 months (time of recruitment in the study).	8 month
Secondary	Evaluate literacy in the care pathway.	"Health Literacy Questionnaire" (HLQ) at 6 month post intervention. Questionnaire contains 2 parts : P1 with 23 questions, and P2 with 21 questions.; Coding: P1Q1 to P1Q23; Strongly Disagree = 1; Disagree = 2; Agree = 3; Strongly Agree = 4; P2Q1 to P2Q21; Cannot do or always difficult, = 1; Usually difficult = 2; Sometimes difficult = 3; Usually easy = 4; Always easy = 5; The HLQ consists of 9 scales representing 9 dimensions of health literacy. Each HLQ scale has 4-6 items. The HLQ does not provide one overall summative score. The scoring of the HLQ is 9 scale scores, calculated by averaging the item scores within each scale with equal weighting. The 9 scale scores will reflect a person's strengths and needs in the different dimensions of health literacy.; For Scales 1 to 5, the score range is between 1 and 4 For Scales 6 to 9, the score range is between 1 and 5	inclusion, 6 month
Secondary	Satisfaction with improvement in orientation to the care pathway	To assess the HQL (Health Literacy Questionnaire) Minimal Clinically Interesting Difference at 6 months after the intervention.; The investigators wish to assess the Minimal Clinically Interesting Difference at 6 months after the intervention by comparing the response about the satisfaction with improvement in orientation to the care pathway (0: No improvement, 1 : Slight improvement, 2 : Good improvement, 3 : Excellent improvement) " to the HLQ dimensions of interest.	6 month
Secondary	Success in orienting to the care pathway	The investigators wish to assess PALS by comparing the response to the question "Do you feel able to learn about services and supports to ensure that all your health needs are met? ( YES/NO)" to the HLQ dimensions of interest.; PALS will be binary, either patients feel able to orient themselves in the care pathway or they do not feel able to do so	inclusion, 6 month
Secondary	Assess satisfaction with the current care pathway	Bilateral 6-item Likert scale at 6 months after surgery (-3: very dissatisfied to +3 very satisfied )	6 month
Secondary	Collect the patient experience	Semi-directive interview conducted at 6 months after the intervention. This interview will be carried out only for some patients of the study until data saturation.	6 month
Secondary	To assess patient adherence, patient believes in the mechanics of TACs operation.	CHBQ questionnaire completed at inclusion (pre-intervention) and at 6 months (post-intervention by the patient.; This questionnaire is composed of 10 propositions. The total score varies between 10 (total disagreement with all the proposals) and 70 (total agreement with all the proposals). The authors suggest that above the median score of 40, the respondent has a positive attitude towards TACs and conversely a negative attitude towards TACs for a score below 40.	inclusion, 6 month
Secondary	To assess co-variance between oncologist and patient beliefs in TACs operating mechanisms	CHBQ questionnaire completed by the oncologist at the beginning of the study (before the start of the inclusion).; This questionnaire is composed of 10 propositions. The total score varies between 10 (total disagreement with all the proposals) and 70 (total agreement with all the proposals). The authors suggest that above the median score of 40, the respondent has a positive attitude towards TACs and conversely a negative attitude towards TACs for a score below 40.	Inclusion
Secondary	To assess the use of TACs	If individuals have used TACs, then they are offered a simplified and adapted version of the CAMP-Q (Complementary and Alternative Medicine Practitioner Use Questionnaire) completed at inclusion and 6 months after the intervention by the patient.; This questionnaire includes 49 questions and the objective will be to evaluate if the patient has used one or more alternative medicines (1) or no alternative medicine (0). It don't have a rating	inclusion, 6 month
Secondary	To assess satisfaction with TACs	Bilateral 6-item Likert scale (-3: very dissatisfied to +3 very satisfied) at baseline and 6 months after the procedure ONLY if at least one complementary alternative technique was checked in answer n°1 of the CAMP Q questionnaire.; This is to have a before and after evaluation.	inclusion, 6 month
Secondary	To assess satisfaction with oncology care.	Two-sided 6-item Likert scale (-3: very dissatisfied to +3 very satisfied ) at 6 months post intervention. These goals are only evaluated for patients in the AFTER group	6 month
Secondary	Assess patient satisfaction with the procedure.	Two-way 6-item Likert scale (-3: very dissatisfied to +3 very satisfied ) evaluated after the intervention and at 6 months. This objective is only evaluated for patients in the AFTER group	After intervention, 6 month
Secondary	Assess patient recommendation of the intervention	Two-way Likert scale with 4 items (-2 not at all agree to +2 completely agree ) evaluated after the intervention and at 6 months. This objective is only evaluated for patients in the AFTER group	After intervention, 6 month