Reintegrating a Systematic Review Consultation With the General Practitioner After the Cancer Diagnosis Has Been Announced Into the Complex Cancer Patient Pathway: Feasibility Study (DAMeGe)

This is a prospective, multicentric, regional study designed to assess the feasibility of setting up a summary consultation with a general practitioner (GP) to complement the consultation for the announcement of a cancer diagnosis.

171 patients will be included in the study.

Each patient will be followed for 6 months.

Study Overview

• Status: Active, not recruiting
• Conditions: Solid Tumours
• Intervention / Treatment: Other: Patient care according to the DAMeGe protocol (organisation of a summary consultation with the GP)

• Study Type: Interventional
• Enrollment (Estimated): 171
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Auch, France
    • CH Auch
  • Carcassonne, France, 11000
    • CH Carcassonne
  • Toulouse, France
    • CHU Rangueil
  • Toulouse, France
    • Institut Universitaire du Cancer de Toulouse - Oncopole
  • Toulouse, France
    • CHU Larrey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years.
2. Patient with a solid tumour whatever the organ.
3. Patient treated in one of the participating centres as part of a system for announcing the diagnosis of a solid cancer.
4. Patient undergoing cancer treatment in one of the participating centres.
5. Patient with a registered general practitioner in the Occitanie region.
6. Patient affiliated to a French Social Security scheme.
7. Patient having signed informed consent prior to inclusion in the study and prior to any specific procedure for the study.

Exclusion Criteria:

1. Patient already included in another clinical trial concerning a care pathway.
2. Patient deprived of liberty or under legal protection (curatorship and guardianship, safeguard of justice).
3. Pregnant or breast-feeding woman.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: DAMeGe protocol

Other: Patient care according to the DAMeGe protocol (organisation of a summary consultation with the GP); A summary consultation with the patient's general practitioner (GP) will take place within 15 days of the consultation to announce the cancer diagnosis. This patient-general practitioner consultation will complement the initial consultation. At the end of the summary consultation, the patient's satisfaction and that of the GP will be assessed using satisfaction questionnaires. In addition, patients will be asked to complete a "patient diary" for the duration of their participation in the study (6 months), in order to record the dates of consultations with the GP and the dates of consultations and/or hospitalisations at the referral care centre.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The ratio between the number of patients who attended the summary consultation with the general practitioner within 15 days of being diagnosed with cancer in the referral care centre and the total number of patients included in the study.	21 months after the start of the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of hospital admissions and unscheduled consultations at the referral centre during the 6 months of follow-up will be assessed for each patient included in the study.		6 months for each patient
The reasons why the summary consultation with the GP did not take place within 15 days of the consultation to announce the cancer diagnosis.	It will be assessed for each patient included in the study in conjunction with the patients or GPs: patient refusal, GP refusal, cancelled or postponed by the patient, cancelled or postponed by the GP, out of time (>15 days), other reason.	21 months after the start of the study
The type of consultations carried out with the GP (physical consultations, teleconsultations or home visits) will be presented as follows, using standard descriptive statistics.		21 months after the start of the study
The number of cancellations of consultations with GPs will be presented as follows, using standard descriptive statistics.		21 months after the start of the study
The number of postponed consultations with the GP will be presented as follows, using standard descriptive statistics.		21 months after the start of the study
The overall compliance will be presented as follows, using standard descriptive statistics.		21 months after the start of the study
The participation will be assessed.	All ratios complementary to the main criterion will be collected and analysed (the number of patients who received the offer to participate in the systematic consultation, the number of patients actually included).	18 months after the start of the study
The socio-demographic characteristics of the patients included will be described and analysed.		21 months after the start of the study
The rate of patients with a change in management between the treatment proposed at the RCP (Multidisciplinary Consultation Meeting) and that carried out in the centre.	It will be presented in the following format: number, percentage and 95% confidence interval (exact binomial distribution).	6 months for each patient
The satisfaction of patients included in the study and of GPs whose patients take part in the study.	It will be assessed using questionnaires. Responses to the questions will be based on a Likert scale of 1 to 4: 'Completely satisfactory', 'Somewhat satisfactory', 'Somewhat unsatisfactory', 'Not at all satisfactory'.	21 months after the start of the study

Collaborators and Investigators

• Sponsor: Institut Claudius Regaud
• Collaborators: Ligue contre le cancer, France

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: September 3, 2024
• First Submitted That Met QC Criteria: September 5, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: General practitioner; Solid Tumours; Announcement system
• Other Study ID Numbers: 24 GENE 07; ID RCB Number: 2024-A00415-42 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No