Needs and Preferences of Patients With Head-neck Cutaneous SCC

NCT ID: NCT06046625

Last Updated: 2025-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-01

Study Completion Date

2025-06-01

Brief Summary

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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

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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.

Conditions

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Head-neck cutaneous Squamous cell carcinomas

Patients with high risk cutaneous squamous cell carcinoma in the head neck region, receiving regular multidisciplinary care.

Regular care with additional administration of a semi-structured interview

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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K Mosterd, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

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Maastricht University Medical Center+

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

References

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Reference Type BACKGROUND
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Other Identifiers

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METC 2021-2765

Identifier Type: -

Identifier Source: org_study_id

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