Solid Tumours
Conditions
Keywords
Solid Tumours, Announcement system, General practitioner
Brief summary
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.
Interventions
OTHERPatient 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.
Sponsors
Institut Claudius Regaud
Ligue contre le cancer, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| 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. | 15 days after the end of the recruitment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The reasons why the summary consultation with the GP did not take place within 15 days of the consultation to announce the cancer diagnosis. | 21 months after the start of the study | 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. |
| 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. | 18 months after the start of the study | 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). |
| 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. | 6 months for each patient | It will be presented in the following format: number, percentage and 95% confidence interval (exact binomial distribution). |
| 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 satisfaction of patients included in the study and of GPs whose patients take part in the study. | 21 months after the start of 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'. |
Countries
France
Outcome results
None listed