Breast CancerNCT05388734
Shared Decision Making on Care Pathways and CAMs: A Pilot Study
A study testing alternative medicine education consultation in people with Breast Cancer and Non-metastatic, run by University Hospital, Grenoble at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Non-metastatic, Newly Diagnosed
- What is being tested?
- alternative medicine education consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 28 Sep 2022to Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Chu Grenoble
Grenoble, 38000
MIREILLE MOUSSEAU
- Not yet recruiting
Pole Sante Saint Martin D'Heres
Saint-Martin-d'Hères, 38400
PAULINE GIRARD
About this study
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.
Read the 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.
- Conditions
- Breast Cancer, Non-metastatic, Newly Diagnosed, Feasibility Study
- Being tested
- alternative medicine education consultation
- Keywords
- Complementary and Alternative Medicine (CAM), breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alternative medicine education consultationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Before group | No intervention | 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 |
| After Group | Active comparator | Patients in the front group are recruited from the 5th month of the study and will benefit from the alternative medicine education consultation Receives: Other: alternative medicine education consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 month
Secondary outcomes (12)
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
Measured: inclusion, 6 month
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.
Measured: 6 month
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
Measured: inclusion, 6 month
Assess satisfaction with the current care pathway
Bilateral 6-item Likert scale at 6 months after surgery (-3: very dissatisfied to +3 very satisfied )
Measured: 6 month
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.
Measured: 6 month
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.
Measured: inclusion, 6 month
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.
Measured: Inclusion
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
Measured: inclusion, 6 month
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.
Measured: inclusion, 6 month
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
Measured: 6 month
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
Measured: After intervention, 6 month
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
Measured: After intervention, 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start28 Sep 2022
- Primary completionJan 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Quasi-experimental, before-and-after, comparative, prospective, single-center, open-label study.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- University Grenoble Alps, Laboratoire TIMC-IMAG
- Responsible party
- Sponsor
- Investigators
- NICOLAS PINSAULT, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388734
- Sponsor's protocol ID
- 2021-A03027-34
- Status last verified
- May 2023
- First submitted
- 18 May 2022
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pinsault N, Girard P, Monvoisin R, Eychenne C, Genty-Vermorel C, Druart L. Development and pilot feasibility of Kit-CAT, a serious-game-supported consultation for discussing complementary and alternative therapies in breast cancer care. Cancer Treat Res Commun. 2026 Jun 4;48:101272. doi: 10.1016/j.ctarc.2026.101272. Online ahead of print.
PubMed 42241921
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision Making on Care Pathways and CAMs: A Pilot Study
- ClinicalTrials.gov ID
- NCT05388734
- Acronym / sponsor ID
- 2021-A03027-34
- Conditions
- Breast Cancer, Non-metastatic, Newly Diagnosed, Feasibility Study
- Keywords
- Complementary and Alternative Medicine (CAM), breast cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- University Grenoble Alps, Laboratoire TIMC-IMAG
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Quasi-experimental, before-and-after, comparative, prospective, single-center, open-label study.
| Arm | Type | Receives |
|---|---|---|
| Before group | No intervention | –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 |
| After Group | Active comparator | Other: alternative medicine education consultationPatients in the front group are recruited from the 5th month of the study and will benefit from the alternative medicine education consultation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alternative medicine education consultationThe 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. | Other | After Group |
Primary outcome
Feasibility of a study proposing a therapeutic education consultation linked to the usual course of care
Time frame: 8 month
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).
12 secondary outcomes
Evaluate literacy in the care pathway.
Time frame: inclusion, 6 month
Satisfaction with improvement in orientation to the care pathway
Time frame: 6 month
Success in orienting to the care pathway
Time frame: inclusion, 6 month
Assess satisfaction with the current care pathway
Time frame: 6 month
Collect the patient experience
Time frame: 6 month
To assess patient adherence, patient believes in the mechanics of TACs operation.
Time frame: inclusion, 6 month
To assess co-variance between oncologist and patient beliefs in TACs operating mechanisms
Time frame: Inclusion
To assess the use of TACs
Time frame: inclusion, 6 month
To assess satisfaction with TACs
Time frame: inclusion, 6 month
To assess satisfaction with oncology care.
Time frame: 6 month
Assess patient satisfaction with the procedure.
Time frame: After intervention, 6 month
Assess patient recommendation of the intervention
Time frame: After intervention, 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Derived from this study: PubMed 42241921Pinsault N, Girard P, Monvoisin R, Eychenne C, Genty-Vermorel C, Druart L. Development and pilot feasibility of Kit-CAT, a serious-game-supported consultation for discussing complementary and alternative therapies in breast cancer care. Cancer Treat Res Commun. 2026 Jun 4;48:101272. doi: 10.1016/j.ctarc.2026.101272. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
NICOLAS PINSAULT principal investigator
University Hospital, Grenoble
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing alternative medicine education consultation in people with Breast Cancer and Non-metastatic, run by University Hospital, Grenoble at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact NICOLAS PINSAULT (0476765040, Npinsault@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of a study proposing a therapeutic education consultation linked to the usual course of care (time frame: 8 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05388734, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.