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Completed

NCT Number: NCT06589414

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

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.

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Key information

Conditions

Solid Tumours

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Auch, Auch, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Patient care according to the DAMeGe protocol (organisation of a summary consultation with the GP)

Other

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.

Primary outcomes

  1. 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.

    Time frame: 15 days after the end of the recruitment

Secondary outcomes

  1. The reasons why the summary consultation with the GP did not take place within 15 days of the consultation to announce the cancer diagnosis.

    Time frame: 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.

  2. The type of consultations carried out with the GP (physical consultations, teleconsultations or home visits) will be presented as follows, using standard descriptive statistics.

    Time frame: 21 months after the start of the study

  3. The number of cancellations of consultations with GPs will be presented as follows, using standard descriptive statistics.

    Time frame: 21 months after the start of the study

  4. The number of postponed consultations with the GP will be presented as follows, using standard descriptive statistics.

    Time frame: 21 months after the start of the study

  5. The overall compliance will be presented as follows, using standard descriptive statistics.

    Time frame: 21 months after the start of the study

  6. The participation will be assessed.

    Time frame: 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).

  7. The socio-demographic characteristics of the patients included will be described and analysed.

    Time frame: 21 months after the start of the study

  8. 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.

    Time frame: 6 months for each patient

    It will be presented in the following format: number, percentage and 95% confidence interval (exact binomial distribution).

  9. 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.

    Time frame: 6 months for each patient

  10. The satisfaction of patients included in the study and of GPs whose patients take part in the study.

    Time frame: 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'.

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Collaborators

  • Ligue contre le cancer, France

Registry information

Acronym: DAMeGe

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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