Impact in Head and Neck Oncology of Support by a Nurse in the Patient's Care Pathway

Head and Neck Cancer Clinical Trial

— COACH-ORL  

Official title:

Impact in Head and Neck Oncology of Support by a Nurse in the Patient's Care Pathway.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06203808
• Other study ID #: RC31/23/0410
• Status: Recruiting
• Start date: February 20, 2024
• Est. completion date: February 28, 2025

Study information

• Verified date: April 2024
• Source: University Hospital, Toulouse
• Contact: AGNES DUPRET-BORIES
• Phone: (0)5 31 15 60 14
• Email: dupretbories.a[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Head and neck cancers (HNC) constitute a significant global health burden, ranking fourth in terms of cancer incidence and fifth in terms of cancer-related mortality. The management of HNC requires a complex array of consultations, examinations, rehabilitation, and lifestyle modifications, including addiction cessation. These cancers disproportionately affect economically disadvantaged, socially isolated individuals, and the elderly, resulting in disparities in healthcare access. Health coaching, an approach aimed at improving patients' health and quality of life by supporting behavior and lifestyle changes, has demonstrated effectiveness in various medical fields, including chronic diseases, medical oncology, and hematology. However, its application in head and neck cancer care remains limited, despite its potential benefits for this patient population.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• COMPLETION OF QUESTIONNAIRES
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.

Locations

Country	Name	City	State
France	Chu de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Potential benefits of personalized patient support using European Organisation for Research and Treatment of Cancer (EORTC) questionnaire	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