Needs and Preferences of Patients With Head-neck Cutaneous SCC

Patient Satisfaction Clinical Trial

Official title:

The Needs and Preferences of Patients With High-risk Cutaneous Squamous Cell Carcinomas in the Head Neck Region: a Qualitative Approach

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06046625
• Other study ID #: METC 2021-2765
• Status: Active, not recruiting
• Start date: November 1, 2021
• Est. completion date: November 30, 2023

Study information

• Verified date: October 2023
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: November 30, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Cutaneous Squamous Cell Carcinoma
• Cutaneous Squamous Cell Carcinoma of the Head and Neck
• Decision Making
• High-Risk Cancer
• Interview
• Patient Satisfaction
• Preference, Patient
• Skin Cancer
• Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck
• Squamous Cell Carcinoma of the Head and Neck

Intervention

Other:
• Regular care with additional administration of a semi-structured interview
Patients receiving regular care. In addition, a semi-structured interview is conducted. The semi-structured interviews take place once after completion of the care pathway (after all appointments for check-ups associated with the treatment). The interview contains questions about the experience of patients with the care, the needs in this care, the experiences with the information received, the support/guidance, the turnaround time, the treatment received and areas for improvement.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center+	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (19)

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van Egmond S, Wakkee M, Droger M, Bastiaens MT, van Rengen A, de Roos KP, Nijsten T, Lugtenberg M. Needs and preferences of patients regarding basal cell carcinoma and cutaneous squamous cell carcinoma care: a qualitative focus group study. Br J Dermatol. 2019 Jan;180(1):122-129. doi: 10.1111/bjd.16900. Epub 2018 Sep 23. — View Citation

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* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Themes patients	The emerging themes of patient needs an experiences in the care of cutaneous squamous cell carcinoma in the head-neck region.	Through study completion, an average of 1 year
Primary	Themes professionals	The emerging themes of professionals' needs in the care of patients with cutaneous squamous cell carcinoma in the head-neck area.	Through study completion, an average of 1 year
Secondary	Association themes and patient/tumor characteristics	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).	Through study completion, an average of 1 year
Secondary	Association themes and professional characteristics	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).	Through study completion, an average of 1 year