Needs and Preferences of Patients With Head-neck Cutaneous SCC

Active, not recruiting

• Conditions: Cutaneous Squamous Cell Carcinoma; Squamous Cell Carcinoma; Skin Cancer; Cutaneous Squamous Cell Carcinoma of the Head and Neck; Squamous Cell Carcinoma of the Head and Neck; Patient Satisfaction; High-Risk Cancer; Preference, Patient; Decision Making; Squamous Cell Carcinoma of Head and Neck
• Interventions: Other: Regular care with additional administration of a semi-structured interview

• Registration Number: NCT06046625
• Lead Sponsor: Maastricht University Medical Center

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.

Study Timeline

• Study Start: 2021-11-01
• Study First Submitted: 2023-08-18
• Study First Submitted QC: 2023-09-13
• Study First Posted: 2023-09-21
• Primary Completion: 2023-11-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Head-neck cutaneous Squamous cell carcinomas	Regular care with additional administration of a semi-structured interview	Patients with high risk cutaneous squamous cell carcinoma in the head neck region, receiving regular multidisciplinary care.

Primary Outcome Measures

Name	Time	Method
Themes professionals	Through study completion, an average of 1 year	The emerging themes of professionals' needs in the care of patients with cutaneous squamous cell carcinoma in the head-neck area.
Themes patients	Through study completion, an average of 1 year	The emerging themes of patient needs an experiences in the care of cutaneous squamous cell carcinoma in the head-neck region.

Secondary Outcome Measures

Name	Time	Method
Association themes and patient/tumor characteristics	Through study completion, an average of 1 year	The associations between the emerging themes and baseline characteristics (such as gender, age, marital status, education level, world health organisation performance status, informal care, history of skin cancer, co-occurrence of other skin cancers) and tumor characteristics (such as stage of cSCC, differentiation, type of treatment).
Association themes and professional characteristics	Through study completion, an average of 1 year	The associations between the emerging themes and characteristics of professionals (gender, age, type of specialty, number of years working as a specialist, number of years of experience within head and neck working group).

Trial Locations

Locations (1)

Maastricht University Medical Center+; 🇳🇱 Maastricht, Netherlands