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Needs and Preferences of Patients With Head-neck Cutaneous SCC

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ClinicalTrials.gov Identifier: NCT06046625
Recruitment Status : Active, not recruiting
First Posted : September 21, 2023
Last Update Posted : October 19, 2023
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Study Description
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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.

Condition or disease Intervention/treatment
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 Other: Regular care with additional administration of a semi-structured interview

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 Design
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Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Needs and Preferences of Patients With High-risk Cutaneous Squamous Cell Carcinomas in the Head Neck Region: a Qualitative Approach
Actual Study Start Date : November 1, 2021
Estimated Primary Completion Date : November 1, 2023
Estimated Study Completion Date : November 30, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Head-neck cutaneous Squamous cell carcinomas
Patients with high risk cutaneous squamous cell carcinoma in the head neck region, receiving regular multidisciplinary care.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Themes patients [ Time Frame: 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.

  2. Themes professionals [ Time Frame: 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.


Secondary Outcome Measures :
  1. Association themes and patient/tumor characteristics [ Time Frame: 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).

  2. Association themes and professional characteristics [ Time Frame: 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06046625


Locations
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Netherlands
Maastricht University Medical Center+
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Principal Investigator: K Mosterd, MD, PhD Maastricht University Medical Center
More Information
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Publications:
Klaus Wolff RAJ, Arturo P. Saavedra, Ellen K. Roh. SECTION 11: PRECANCEROUS LESIONS AND CUTANEOUS CARCINOMAS. Fitzpatrick's Color Atlas and Synopsis of Clinical Dermatology. Eigth edition ed: McGraw-Hill Education; 2017

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT06046625    
Other Study ID Numbers: METC 2021-2765
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: October 19, 2023
Last Verified: October 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maastricht University Medical Center:
Patient experience
Patients need
Semi-structured
 Professionals
Experience
Needs
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Head and Neck Neoplasms