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

NCT06203808 | Recruiting

• 1 other identifier: RC31/23/0410
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Other: COMPLETION OF QUESTIONNAIRES

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.

Other: COMPLETION OF QUESTIONNAIRES

Interventions

COMPLETION OF QUESTIONNAIRES OTHER

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.

COACH GROUP; CONTROL GROUP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a histologically proven diagnosis of head and neck squamous cell carcinoma (HNSCC) of the upper aerodigestive tract

You may qualify if:

• 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.
• Patient with a history of previous cervical surgery and/or head and neck irradiation
• Pregnant or breastfeeding women
• 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).

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Chu de Toulouse

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• AGNES DUPRET-BORIES

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AGNES DUPRET-BORIES

CONTACT

(0)5 31 15 60 14; dupretbories.a@chu-toulouse.fr

MARIANNE LESCOUZERES

CONTACT

lescouzeres.m@chu-toulouse.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: January 12, 2024
• Study Start: February 20, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: April 4, 2024

Record last verified: 2024-04

Locations

FR (1)