此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Screening Psychosocial Distress in Head and Neck Cancer (DEP-VADS-ORTHO)

2026年9月25日 更新者:Hôpital NOVO

Psychosocial Distress Screening in Patients Treated for Head and Neck Cancer : The Value of Screening in Speech-Language Therapy Practice

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.

The 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.

研究概览

详细说明

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.

Survivors 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.

The 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/or 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.

To 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.

The 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.

To 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.

研究类型

观察性的

注册 (估计的)

80

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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

描述

Inclusion Criteria:

  • Adult patients aged 18 years or older
  • Patients managed following a diagnosis of squamous cell carcinoma of the upper aerodigestive tract
  • Requiring speech-language pathology care
  • Initiation of curative-intent treatment dating back less than one month
  • Sufficient understanding of the French language to complete the study questionnaires
  • Patient who has been informed about the research and has not expressed any objection to participating

Exclusion Criteria:

  • Palliative care initiated
  • Severe cognitive impairment preventing the completion of the questionnaire
  • Clinical condition preventing participation
  • Severe, unstabilized psychiatric disorders

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:COHORT
  • 时间观点:PROSPECTIVE

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Proportion of patients presenting with psychosocial distress at the initiation of speech language therapy
大体时间:At the first speech-language therapy session (baseline)

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)

次要结果测量

结果测量
措施说明
大体时间
Correlation between psychosocial distress score and indicators of patient engagement in speech-language therapy
大体时间:Baseline (first speech-language therapy session) and 2 months after baseline (±10 days)

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)
Correlation between psychosocial distress score, functional disorders, and quality of life
大体时间:Baseline (first speech-language therapy session) and 2 months after baseline (±10 days)

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

Baseline (first speech-language therapy session) and 2 months after baseline (±10 days)
Change in psychosocial distress score over time
大体时间:From baseline (first speech-language therapy session) to 2 months after baseline (±10 days)

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)
Change in quality of Life scores over time
大体时间:From baseline (first speech-language therapy session) to 2 months after baseline (±10 days)

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).

From baseline (first speech-language therapy session) to 2 months after baseline (±10 days)
Change in functional disorder scores over time
大体时间:From baseline (first speech-language therapy session) to 2 months after baseline (±10 days)

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).

From baseline (first speech-language therapy session) to 2 months after baseline (±10 days)
Screening acceptance rate
大体时间:Baseline (first speech-language therapy session)

Proportion of patients who agree to undergo the psychosocial distress screening among all eligible and approached patients

Baseline (first speech-language therapy session)
Rate of patient referral to psychological support professionals
大体时间:Throughout the 2-month study period

Proportion of patients who benefit from a referral to a psychological or psychosocial support professional following the screening

Throughout the 2-month study period

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 学习椅:Marion LEROUX、Hôpital NOVO
  • 首席研究员:Alexandra POULAIN、SMR Val Rosay

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月30日

初级完成 (估计的)

2027年11月30日

研究完成 (估计的)

2028年1月30日

研究注册日期

首次提交

2026年9月21日

首先提交符合 QC 标准的

2026年9月25日

首次发布 (实际的)

2026年10月1日

研究记录更新

最后更新发布 (实际的)

2026年10月1日

上次提交的符合 QC 标准的更新

2026年9月25日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅