Clinical trial NCT06046625: Needs and Preferences of Patients With Head-neck Cutaneous SCC
Official title: The Needs and Preferences of Patients With High-risk Cutaneous Squamous Cell Carcinomas in the Head Neck Region: a Qualitative Approach
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cutaneous Squamous Cell Carcinoma
Cutaneous Squamous Cell Carcinoma of the Head and Neck
Squamous Cell Carcinoma
Squamous Cell Carcinoma of Head and Neck
Squamous Cell Carcinoma of the Head and Neck
Skin Cancer
Patient Satisfaction
High-Risk Cancer
Preference, Patient
Decision Making
Interview
Keywords: Patient experience
Patients need
Semi-structured
Professionals
Experience
Needs
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients, over 18 years of age, clinically diagnosed with a cutaneous squamous cell carcinoma localized in the head and neck area, seen in the MUMC+ at the multidisciplinary head-neck consultation of the department of dermatology, who have already been treated for this cSCC and are willing to participate in the study will be included. If the patient is cognitively unable to participate in the interview, alternatively, a representative may participate in the interview.

Brief summary: The care of patients with high-risk cutaneous squamous cell carcinomas in the head-neck area is complex and requires a multidisciplinary approach. A key component in this care is the need and experience of patients. However, studies on the experiences and needs of patients with high-risk cutaneous squamous cell carcinomas in the head-neck region are lacking.

Detailed description: Cutaneous squamous cell carcinoma (cSCC) is the second most common form of skin cancer worldwide after basal cell carcinoma. It involves approximately 20% of all cutaneous malignancies and its incidence is still increasing. In 2020, nearly 15,000 cSCCs were reported in the Netherlands, of which approximately 50% concerned patients aged 75 years or older. UV radiation is the main risk factor for development of a cSCC, therefore the majority of cSCCs are localized to the sun-exposed skin in the head-neck region. cSCCs have a metastatic rate of 2.6-5% and recurrence rate of 1.9-3.7%, with rates increasing in high-risk cSCCs. The increasing incidence, advanced age, the (often) high-risk localization in the head-neck area (given functional and cosmetic importance) and the possible high risk of metastasis result in complex care, especially in stage T2 to T4 cSCCs, also known as high-risk cSCCs.

In this complex care, care pathways offer an excellent opportunity to improve multidisciplinary communication, patient satisfaction, quality and efficiency of care. In this, the experiences and needs of patients are of great importance. Previous research on the experiences and needs of patients with skin cancer is limited and particularly focused on melanomas. In 2017, a qualitative systematic review of the experiences and needs of patients with skin cancer found only two studies examining cSCCs. These studies showed that patients perceived clear information, attention to psychosocial aspects and attention to prevention as important.

In 2019, a study of the needs and experiences of patients with keratinocyte carcinomas, conducted through focus groups, showed similar results. Non of these studies examined cSCCs exclusively, nor did they differentiate by location. However, this appears to be relevant, because of the higher impact on the quality of life of patients with skin cancer in visible locations.

Additionally, studies have been conducted into shared-decision making as part of multidisciplinary care. Complex cases are currently often discussed multidisciplinary. However, several studies describe that such a multidisciplinary approach can impede multidisciplinary decision-making because the patient's perspective is often missing. Studies on the experience of patients with cSCCs in the head neck region are lacking.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with a cSCC, located in the head-neck region
* who visited the multidisciplinary head-neck team of the Maastricht University Medical Center+
* who already received treatment for their cSCC
* who gave informed consent for participation

Exclusion Criteria:

- patients who are cognitively impaired for participation in an interview

Primary outcomes:
measure: Themes patients
timeFrame: Through study completion, an average of 1 year
measure: Themes professionals
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Association themes and patient/tumor characteristics
timeFrame: Through study completion, an average of 1 year
measure: Association themes and professional characteristics
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center+
Study officials:
affiliation: Maastricht University Medical Center
name: K Mosterd, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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