Screening Psychosocial Distress in Head and Neck Cancer

NCT07851818 | Not Yet Recruiting

• 2 other identifiers: CHRD16262026-A01692-49
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Head and Neck Cancer (H&N)

Keywords

Head and Neck Neoplasms; Squamous Cell Carcinoma; Psychological Distress; Emotional Distress; Language therapies; Quality of Life; Patient Engagement; Supportive Care Oncology

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (7)

• Correlation between psychosocial distress score and indicators of patient engagement in speech-language therapy

  Baseline (first speech-language therapy session) and 2 months after baseline (±10 days)

• Correlation between psychosocial distress score, functional disorders, and quality of life

  Baseline (first speech-language therapy session) and 2 months after baseline (±10 days)

• Change in psychosocial distress score over time

  From baseline (first speech-language therapy session) to 2 months after baseline (±10 days)

• Change in quality of Life scores over time

  From baseline (first speech-language therapy session) to 2 months after baseline (±10 days)

• Change in functional disorder scores over time

  From baseline (first speech-language therapy session) to 2 months after baseline (±10 days)

Interventions

Psychosocial distress screening using the Distress Thermometer OTHER

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).

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

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hôpital NOVO: lead

MeSH Terms

Conditions

Head and Neck Neoplasms; Carcinoma, Squamous Cell; Patient Participation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Marion LEROUX

  Hôpital NOVO

  STUDY CHAIR

• Alexandra POULAIN

  SMR Val Rosay

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Véronique DA COSTA

CONTACT

0130755069; veronique.dacosta@ght-novo.fr

Study Design

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

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: October 1, 2026
• Study Start (Estimated): November 30, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): January 30, 2028
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share