- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06203808
Impact in Head and Neck Oncology of Support by a Nurse in the Patient's Care Pathway (COACH-ORL)
Impact in Head and Neck Oncology of Support by a Nurse in the Patient's Care Pathway.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a prospective monocentric comparative investigation conducted over 12 months. Two groups are being compared: the COACH group and the control group. The COACH group consists of newly diagnosed head and neck cancer patients seen in consultation for treatment information at University Hospital during the first two months of the study. These patients receive coaching support from a specialized nurse, facilitating appointment scheduling, treatment coordination, and access to various rehabilitation services. In contrast, the control group includes patients who received treatment information during the third and fourth months of the study, without receiving specific coaching support. Both groups of patients will complete quality of life questionnaires at the time of treatment information, at 3 months, 6 months, and at 12 months.
Hypothesis: the investigators assume a minimum difference of 5 points between the control group and the coaching group.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: AGNES DUPRET-BORIES
- Phone Number: +33 (0)5 31 15 60 14
- Email: dupretbories.a@chu-toulouse.fr
Study Contact Backup
- Name: MARIANNE LESCOUZERES
- Email: lescouzeres.m@chu-toulouse.fr
Study Locations
-
-
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Toulouse, France
- Recruiting
- CHU de Toulouse
-
Contact:
- AGNES DUPRET-BORIES
- Phone Number: +33 (0)5 31 15 60 14
- Email: dupretbories.a@chu-toulouse.fr
-
Contact:
- MARIANNE LESCOUZERES
- Email: lescouzeres.m@chu-toulouse.fr
-
Principal Investigator:
- AGNES DUPRET-BORIES
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria:
- Patient with a histologically proven diagnosis of head and neck squamous cell carcinoma (HNSCC) of the upper aerodigestive tract
- Patient whose disease is classified UICC (Union for International Cancer Control (UICC) Tumour, Node, Metastasis (TNM) stage (8th edition): T0-4a NO/N3 M0 (no distant metastasis M0)
- Patient World Health Organization (WHO) 0-1-2
- Treatment with a feasible curative aim (no contraindication to optimal treatment such as surgery or chemotherapy at a curative dose)
- Patient affiliated to a Social Security scheme in France
- Patient who did not object to participating in the research.
Non-inclusion criteria:
- Patient with a history of previous cervical surgery and/or head and neck irradiation
- Pregnant or breastfeeding women
- Patient suffering from another co-existing malignant disease at the time of inclusion or any other significant medical (immunosuppression etc.), psychiatric or surgical condition, currently not controlled by treatment, which may interfere with the achievement of the study.
- Any psychological, family, geographic or sociological condition that does not allow compliance with medical monitoring and/or the procedures provided for in the study protocol.
- Patients deprived of liberty or under legal protection regime (curatorship and guardianship, safeguard of justice).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
COACH GROUP
The COACH group consists of newly diagnosed head and neck cancer patients seen in consultation for treatment information at Oncologic University Hospital during the first two months of the study.
These patients receive coaching support from a specialized nurse, facilitating appointment scheduling, treatment coordination, and access to various rehabilitation services
|
Both groups of patients will complete quality of life questionnaires at the time of treatment information, at 3 months, 6 months and at 12 months.
|
CONTROL GROUP
The control group includes patients who received the treatment information during the third and fourth months of the study, without receiving specific coaching support.
|
Both groups of patients will complete quality of life questionnaires at the time of treatment information, at 3 months, 6 months and at 12 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Potential benefits of personalized patient support using European Organisation for Research and Treatment of Cancer (EORTC) questionnaire
Time Frame: 12 months
|
The main objective of this study is to evaluate the impact on the quality of life of patients treated for upper aerodigestive tract cancer of support by a nurse during the care pathway; and this from the moment of diagnosis and up to 12 months afterwards. Measure of the impact on quality of life using the validated questionnaire most commonly used in oral cancerology, i.e. EORTC Quality of Life Questionnaire (QLQ) - Head and Neck Cancer (EORTC QLQ-H&N43). |
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: AGNES DUPRET-BORIES, University Hospital, Toulouse
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/23/0410
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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