[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658579":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":43,"studyPopulation":44,"armGroups":39,"interventions":45,"overallOfficials":49,"centralContacts":57,"locations":39,"responsibleParty":63,"collaborators":39,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":39,"enrollmentInfo":75,"targetDuration":39,"studyType":78,"phases":39,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":91,"whyStopped":39,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":39},{"fullName":5,"class":6},"Hôpital NOVO","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":39},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of patients presenting with psychosocial distress at the initiation of speech language therapy","Proportion of patients identified as experiencing clinically significant psychosocial distress during their first speech-language therapy session, evaluated using the Distress Thermometer (score ≥ 4)","At the first speech-language therapy session (baseline)",[14,18,21,25,28,31,35],{"measure":15,"description":16,"timeFrame":17},"Correlation between psychosocial distress score and indicators of patient engagement in speech-language therapy","Assessment of the correlation between psychosocial distress score (measured by the Distress Thermometer) and indicators of patient engagement in speech-language therapy, including the number of canceled appointments, the number of rescheduled appointments, and the patient engagement score evaluated by the speech-language pathologist using the revised Hopkins Rehabilitation Engagement Rating Scale (HRERS-RV)","Baseline (first speech-language therapy session) and 2 months after baseline (±10 days)",{"measure":19,"description":20,"timeFrame":17},"Correlation between psychosocial distress score, functional disorders, and quality of life","Description: Evaluation of the correlation between the psychosocial distress score (measured by the Distress Thermometer and its Problem List) and scores assessing functional disorders and quality of life using the EORTC QLQ-C30 and EORTC QLQ-HN35 questionnaires",{"measure":22,"description":23,"timeFrame":24},"Change in psychosocial distress score over time","Evaluation of the variation in the psychosocial distress score using the Distress Thermometer between T0 (baseline, first speech-language therapy session) and T1 (2 months after baseline, ±10 days)","From baseline (first speech-language therapy session) to 2 months after baseline (±10 days)",{"measure":26,"description":27,"timeFrame":24},"Change in quality of Life scores over time","Evaluation of the variation in EORTC QLQ-C30 scores between T0 (baseline, first speech-language therapy session) and T1 (2 months after baseline, ±10 days).",{"measure":29,"description":30,"timeFrame":24},"Change in functional disorder scores over time","Evaluation of the variation in EORTC QLQ-HN35 scores between T0 (baseline, first speech-language therapy session) and T1 (2 months after baseline, ±10 days).",{"measure":32,"description":33,"timeFrame":34},"Screening acceptance rate","Proportion of patients who agree to undergo the psychosocial distress screening among all eligible and approached patients","Baseline (first speech-language therapy session)",{"measure":36,"description":37,"timeFrame":38},"Rate of patient referral to psychological support professionals","Proportion of patients who benefit from a referral to a psychological or psychosocial support professional following the screening","Throughout the 2-month study period",null,{"allocation":39,"interventionModel":39,"interventionModelDescription":39,"primaryPurpose":39,"observationalModel":41,"timePerspective":42,"maskingInfo":39},"COHORT","PROSPECTIVE","The announcement of cancer marks a major turning point in the lives of those affected, profoundly impacting the physical, psychological, and social dimensions of their daily lives1. Head and neck cancer (HNC) perfectly illustrates this reality, as it is frequently associated in the literature with pain, disfigurement, dysfunction, and psychosocial distress2. Referred to in the literature as \"Head and Neck Cancer,\" it encompasses a group of malignant tumors affecting a complex anatomical region situated at the crossroads of the respiratory, phonatory, and digestive systems. The impairment of two vital functions, respiration and swallowing, as well as phonation, highlights the vulnerable and traumatic nature of this cancer3. In 2022, global cancer statistics recorded nearly 947,000 new cases of head and neck cancer, placing it 7th among the most frequent cancers worldwide4. Predominantly male, its incidence is nevertheless increasing in women, partly due to increased exposure to certain risk factors (tobacco and alcohol consumption), as well as an increase in tumors associated with human papillomavirus (HPV)5. In France, the National Cancer Institute6 estimates that approximately 15,000 new cases of HNC are diagnosed each year, causing nearly 3,600 deaths.\n\nSurvivors of HNC report significant repercussions on their daily functioning, particularly regarding eating, speech, pain, and physical appearance7. HNC treatments are heavy and frequently rely on various approaches combining surgical resection, radiotherapy, and chemotherapy2,8. While these strategies improve tumor control, they also expose patients to often persistent adverse effects. Long-term psychosocial disorders (anxiety, mood disorders, fatigue, depression) also alter the patient's overall quality of life. The fear of no longer being able to speak or be heard, the fear of suffocating or no longer being able to eat normally are major anxiety-inducing factors9. More tragically, psychological disorders may be responsible for higher suicide rates in HNC patients. A 2025 systematic review with meta-analysis demonstrates a suicide risk incidence three times higher than that of the general population, particularly among men10.\n\nThe psychological, social, and behavioral dimensions associated with cancer are therefore essential components of the disease, influencing both the patient's experience, their adaptation to the diagnosis, and their engagement in care11. Over the past two decades, psychosocial (or emotional) distress has progressively been recognized as a central issue in psycho-oncology, to the point of being qualified as the \"sixth vital sign,\" after temperature, respiration, heart rate, blood pressure, and pain12. This recognition reflects a major evolution in care models, now integrating psychological and social dimensions into the global assessment of cancers patients. According to the National Comprehensive Cancer Network, distress is defined as \" a multifactorial unpleasant experience of a psychological (i.e., cognitive, behavioral, and emotional), social, spiritual, and\u002For physical nature that may interfere with a person's ability to cope effectively with cancer, its physical symptoms, and its treatment. Distress spans a continuum, ranging from common and normal feelings of vulnerability, sadness, and fears, to problems that can become disabling, such as depression, anxiety, panic, social isolation, as well as existential and spiritual crisis. \".3 Among HNC patients, this issue appears particularly prominent. HNC ranks high among those generating very high levels of distress, behind lung cancer, breast cancer, pancreatic cancer, and Hodgkin's lymphoma13. Emotional distress also represents a major clinical challenge. Zabora et al. (2001) emphasize that when left unrecognised and unmanaged, it can compromise therapeutic outcomes, impair quality of life, and increase healthcare costs14. Despite its high prevalence demonstrated in HNC patients, psychosocial distress is still poorly screened and insufficiently managed in routine care3. It is therefore frequently under-identified and undertreated in clinical practice15. However, National Comprehensive Cancer Network (NCCN) recommendations emphasize the implementation of regular screening at various key moments of the care pathway, particularly at diagnostic disclosure, during treatments, and during post-therapeutic follow-up, to allow early identification of struggling patients3.\n\nTo identify the level and nature of distress, the Distress Thermometer was designed and recommended by the NCCN in 199716. On a scale from 0 to 10, with 0 representing no distress and 10 maximum distress, the person graphically indicates their feelings over the past week. The Distress Thermometer is a reliable and validated instrument, widely tested internationally, and translated into 21 languages, including French17. A threshold of 4 is frequently used to identify clinically significant distress, although this may vary across populations and cultural contexts. The Distress Thermometer is completed by the Canadian Problem List, allowing the collection of the patient's physical, emotional, social, practical, and spiritual concerns18.\n\nThe assessment of the needs of HNC patients is part of the foundations of speech-language pathology (SLP) evaluation19. The SLP care of patients, often undergoing major surgeries, is particularly complex and addresses individuals largely confronted with major disruptions in their social reference points9. Assessments of voice, speech, and swallowing must be performed by the SLP, who will propose appropriate interventions to maintain these functions upstream of treatment. Speech therapy also extends to the management of post-treatment complications, such as trismus or radiation-induced fibrosis. According to Zuydam et al. (2023), establishing a solid therapeutic relationship makes it possible to identify patient concerns19. Indeed, unmet needs have been identified in 60% to 70% of patients diagnosed with HNC20. Taking these different dimensions into account is therefore part of a perspective of improving care outcomes, preserving patients' quality of life, and increasing their satisfaction with care21. This cross-functional competency of psychosocial support, offered by professionals involved in regular cancer care, appears essential here and must not be underestimated22 . Although psychosocial distress screening is recommended throughout the cancer care pathway, ils integration into routine clinical practice remains poorly documented, particulary in the field of speech-language pathology. Speech-language pathologists play a specific role in care pathway of patients with HNC because their involvement is early and regular and focuses on the functional consequences of cancer and its treatments. This close and repeated contact with patients may place them in a relevant position to identify psychosocial difficulties encountered during care.\n\nTo date, no study has specifically investigated the relevance of integrating systematic psychosocial distress screening by speech-language pathologists at the beginning of care in patients treated for HNC. The DEP-VADS-ORTHO study may therefore contribute to assessing the relevance of incorporating the Distress Thermometer into routine speech-language pathology practice and to better defining the role of speech-language pathologists within the multidisciplinary care pathway of these patients.","The study population will consist of patients receiving care for head and neck cancer at participating centers and referred for speech-language therapy as part of their clinical management. Participants will be recruited at the initiation of speech-language therapy",[46],{"type":6,"name":47,"description":48,"armGroupLabels":39,"otherNames":39},"Psychosocial distress screening using the Distress Thermometer","Administration of the Distress Thermometer and its accompanying Problem List to patients at the initiation of speech-language therapy to identify clinically significant psychosocial distress (score ≥ 4).",[50,53],{"name":51,"affiliation":5,"role":52},"Marion LEROUX","STUDY_CHAIR",{"name":54,"affiliation":55,"role":56},"Alexandra POULAIN","SMR Val Rosay","PRINCIPAL_INVESTIGATOR",[58],{"name":59,"role":60,"phone":61,"phoneExt":39,"email":62},"Véronique DA COSTA","CONTACT","0130755069","veronique.dacosta@ght-novo.fr",{"type":64,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100658579","screening-psychosocial-distress-in-head-and-neck-cancer-100658579",false,"NCT07851818","Screening Psychosocial Distress in Head and Neck Cancer","Psychosocial Distress Screening in Patients Treated for Head and Neck Cancer : The Value of Screening in Speech-Language Therapy Practice","DEP-VADS-ORTHO","Inclusion Criteria:\n\n* Adult patients aged 18 years or older\n* Patients managed following a diagnosis of squamous cell carcinoma of the upper aerodigestive tract\n* Requiring speech-language pathology care\n* Initiation of curative-intent treatment dating back less than one month\n* Sufficient understanding of the French language to complete the study questionnaires\n* Patient who has been informed about the research and has not expressed any objection to participating\n\nExclusion Criteria:\n\n* Palliative care initiated\n* Severe cognitive impairment preventing the completion of the questionnaire\n* Clinical condition preventing participation\n* Severe, unstabilized psychiatric disorders","ALL","18 Years",{"count":76,"type":77},80,"ESTIMATED","OBSERVATIONAL","This prospective, multicenter study aims to assess the presence of psychosocial distress using the Distress Thermometer in patients treated for head and neck cancer at the initiation of their speech-language therapy. It also seeks to evaluate the evolution of this distress over a two-month period, as well as its correlation with patient engagement in therapy, functional disorders, and overall quality of life (assessed using the EORTC QLQ-C30 and QLQ-HN35 questionnaires). By capturing longitudinal changes in distress levels, functional impairments, and patient commitment to therapy, this research seeks to clarify the SLP's role in comprehensive supportive oncology care and optimize timely psychological referrals for vulnerable patients.\n\nThe study hypothesizes that a significant proportion of patients experience clinically meaningful psychosocial distress (score ≥ 4 on the Distress Thermometer) at the start of speech-language therapy. It is also expected that this distress correlates with lower therapeutic engagement and impaired quality of life, and that early screening by speech-language pathologists will improve the timely referral of patients to psychological support professionals.",[81],"Head and Neck Cancer (H&N)",[83,84,85,86,87,88,89,90],"Head and Neck Neoplasms","Squamous Cell Carcinoma","Psychological Distress","Emotional Distress","Language therapies","Quality of Life","Patient Engagement","Supportive Care Oncology","NOT_YET_RECRUITING","2026-09-25",{"date":94,"type":95},"2026-10-01","ACTUAL",{"date":97,"type":77},"2026-11-30",{"date":99,"type":77},"2028-01-30",{"name":5,"class":6}]