NCT05388734

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 24, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

September 28, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

1.3 years

First QC Date

May 18, 2022

Last Update Submit

May 13, 2023

Conditions

Breast CancerNon-metastaticNewly DiagnosedFeasibility Study

Keywords

Complementary and Alternative Medicine (CAM)breast cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Evaluate literacy in the care pathway.

    inclusion, 6 month

  • Satisfaction with improvement in orientation to the care pathway

    6 month

  • Success in orienting to the care pathway

    inclusion, 6 month

  • Assess satisfaction with the current care pathway

    6 month

  • Collect the patient experience

    6 month

  • +7 more secondary outcomes

Study Arms (2)

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

Other: alternative medicine education consultation

Interventions

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.

After Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Subject under administrative or judicial supervision
  • Subject unable to be contacted in case of emergency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chu Grenoble

Grenoble, 38000, France

RECRUITING

Pole Sante Saint Martin D'Heres

Saint-Martin-d'Hères, 38400, France

NOT YET RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • NICOLAS PINSAULT

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Central Study Contacts

NICOLAS PINSAULT

CONTACT

0476765040Npinsault@chu-grenoble.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Quasi-experimental, before-and-after, comparative, prospective, single-center, open-label study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2022

First Posted

May 24, 2022

Study Start

September 28, 2022

Primary Completion

January 1, 2024

Study Completion

August 1, 2024

Last Updated

May 16, 2023

Record last verified: 2023-05

Locations

FR(2)