Screening Psychosocial Distress in Head and Neck Cancer
ConditionHead and Neck Cancer (H&N)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHôpital NOVO
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Palliative care initiated
Severe cognitive impairment preventing the completion of the questionnaire
Clinical condition preventing participation
Severe, unstabilized psychiatric disorders
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Psychosocial distress screening using the Distress Thermometer
Other interventionAdministration 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).
Treatment groups
No treatment groups listed
Trial outcomes
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)
Time frame
At the first speech-language therapy session (baseline)Secondary outcomes
1
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)
Time frame
Baseline (first speech-language therapy session) and 2 months after baseline (±10 days)2
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
Time frame
Baseline (first speech-language therapy session) and 2 months after baseline (±10 days)3
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)
Time frame
From baseline (first speech-language therapy session) to 2 months after baseline (±10 days)4
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).
Time frame
From baseline (first speech-language therapy session) to 2 months after baseline (±10 days)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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