Head and Neck CancerCOACH-ORLNCT06203808
Impact in Head and Neck Oncology of Support by a Nurse in the Patient's Care Pathway
An observational study of Head and Neck Cancer, run by University Hospital, Toulouse at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- COMPLETION OF QUESTIONNAIRES
- How many people
- 320 participants
- Where
- 1 siteFrance
- Study dates
- 20 Feb 2024to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a histologically proven diagnosis of head and neck squamous cell carcinoma (HNSCC) of the upper aerodigestive tract
Who may be able to join
- 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.
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- 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).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
MARIANNE LESCOUZERES contact
France1 site, 1 recruiting
- Recruiting
Chu de Toulouse
Toulouse
AGNES DUPRET-BORIES, (0)5 31 15 60 14 ext. +33, dupretbories.a@chu-toulouse.fr
MARIANNE LESCOUZERES, lescouzeres.m@chu-toulouse.fr
About this study
Official title: Impact in Head and Neck Oncology of Support by a Nurse in the Patient's Care Pathway.
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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- COMPLETION OF QUESTIONNAIRES
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COMPLETION OF QUESTIONNAIRESOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: COMPLETION OF QUESTIONNAIRES |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start20 Feb 2024
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- AGNES DUPRET-BORIES, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203808
- Sponsor's protocol ID
- RC31/23/0410
- Acronym
- COACH-ORL
- Status last verified
- Apr 2024
- First submitted
- 12 Dec 2023
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact in Head and Neck Oncology of Support by a Nurse in the Patient's Care Pathway.
- ClinicalTrials.gov ID
- NCT06203808
- Acronym / sponsor ID
- COACH-ORL / RC31/23/0410
- Conditions
- Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COACH GROUP | – | Other: COMPLETION OF QUESTIONNAIRESThe 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 |
| CONTROL GROUP | – | Other: COMPLETION OF QUESTIONNAIRESThe control group includes patients who received the treatment information during the third and fourth months of the study, without receiving specific coaching support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a histologically proven diagnosis of head and neck squamous cell carcinoma (HNSCC) of the upper aerodigestive tract
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COMPLETION OF QUESTIONNAIRESBoth groups of patients will complete quality of life questionnaires at the time of treatment information, at 3 months, 6 months and at 12 months. | Other | COACH GROUP, CONTROL GROUP |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MARIANNE LESCOUZERES contact
AGNES DUPRET-BORIES principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AGNES DUPRET-BORIES ((0)5 31 15 60 14 ext. +33, dupretbories.a@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Potential benefits of personalized patient support using European Organisation for Research and Treatment of Cancer (EORTC) questionnaire (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.