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Cutaneous Squamous Cell CarcinomaNCT06046625

Needs and Preferences of Patients With Head-neck Cutaneous SCC

An observational study of Cutaneous Squamous Cell Carcinoma and Cutaneous Squamous Cell Carcinoma of the Head and Neck, run by Maastricht University Medical Center at 1 site in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Regular care with additional administration of a semi-structured interview
How many people
15 participants
Where
1 siteNetherlands
Study dates
1 Nov 2021to 1 Jun 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • patients who are cognitively impaired for participation in an interview

Trial locations and contacts

1 site in 1 country.

Netherlands1 site
  • Maastricht University Medical Center+

    Maastricht

Other trials in Netherlands

About this study

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

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.

Read the 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.

Being tested
Regular care with additional administration of a semi-structured interview
Keywords
Patient experience, Patients need, Semi-structured, Professionals, Experience, Needs
Medical subject headings
Carcinoma, Squamous Cell, Squamous Cell Carcinoma of Head and Neck, Skin Neoplasms, Patient Satisfaction, Patient Preference

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Regular care with additional administration of a semi-structured interviewOther

    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.

Study groups in NCT06046625
Study groupRoleWhat they receive
Head-neck cutaneous Squamous cell carcinomasPatients with high risk cutaneous squamous cell carcinoma in the head neck region, receiving regular multidisciplinary care.
Receives: Other: Regular care with additional administration of a semi-structured interview

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Themes patients

    The emerging themes of patient needs an experiences in the care of cutaneous squamous cell carcinoma in the head-neck region.

    Measured: Through study completion, an average of 1 year

  2. Themes professionals

    The emerging themes of professionals' needs in the care of patients with cutaneous squamous cell carcinoma in the head-neck area.

    Measured: Through study completion, an average of 1 year

Secondary outcomes (2)
  1. 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).

    Measured: Through study completion, an average of 1 year

  2. 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).

    Measured: Through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2023
  2. Study start1 Nov 2021
  3. Primary completion1 Nov 2023
  4. Study completion1 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06046625
Sponsor's protocol ID
METC 2021-2765
Status last verified
Mar 2025
First submitted
18 Aug 2023
Last updated
4 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Fania L, Didona D, Di Pietro FR, Verkhovskaia S, Morese R, Paolino G, Donati M, Ricci F, Coco V, Ricci F, Candi E, Abeni D, Dellambra E. Cutaneous Squamous Cell Carcinoma: From Pathophysiology to Novel Therapeutic Approaches. Biomedicines. 2021 Feb 9;9(2):171. doi: 10.3390/biomedicines9020171.

    PubMed 33572373
  • Stratigos AJ, Garbe C, Dessinioti C, Lebbe C, Bataille V, Bastholt L, Dreno B, Fargnoli MC, Forsea AM, Frenard C, Harwood CAlpha, Hauschild A, Hoeller C, Kandolf-Sekulovic L, Kaufmann R, Kelleners-Smeets NW, Malvehy J, Del Marmol V, Middleton MR, Moreno-Ramirez D, Pellecani G, Peris K, Saiag P, van den Beuken-van Everdingen MHJ, Vieira R, Zalaudek I, Eggermont AMM, Grob JJ; European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO) and the European Organization for Research and Treatment of Cancer (EORTC). European interdisciplinary guideline on invasive squamous cell carcinoma of the skin: Part 1. epidemiology, diagnostics and prevention. Eur J Cancer. 2020 Mar;128:60-82. doi: 10.1016/j.ejca.2020.01.007. Epub 2020 Feb 26.

    PubMed 32113941
  • Stern RS; PUVA Follow-Up Study. The risk of squamous cell and basal cell cancer associated with psoralen and ultraviolet A therapy: a 30-year prospective study. J Am Acad Dermatol. 2012 Apr;66(4):553-62. doi: 10.1016/j.jaad.2011.04.004. Epub 2012 Jan 20.

    PubMed 22264671
  • Kallini JR, Hamed N, Khachemoune A. Squamous cell carcinoma of the skin: epidemiology, classification, management, and novel trends. Int J Dermatol. 2015 Feb;54(2):130-40. doi: 10.1111/ijd.12553. Epub 2014 Nov 27.

    PubMed 25428226
  • 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

  • Que SKT, Zwald FO, Schmults CD. Cutaneous squamous cell carcinoma: Incidence, risk factors, diagnosis, and staging. J Am Acad Dermatol. 2018 Feb;78(2):237-247. doi: 10.1016/j.jaad.2017.08.059.

    PubMed 29332704
  • Mourouzis C, Boynton A, Grant J, Umar T, Wilson A, Macpheson D, Pratt C. Cutaneous head and neck SCCs and risk of nodal metastasis - UK experience. J Craniomaxillofac Surg. 2009 Dec;37(8):443-7. doi: 10.1016/j.jcms.2009.07.007. Epub 2009 Aug 27.

    PubMed 19713116
  • Brantsch KD, Meisner C, Schonfisch B, Trilling B, Wehner-Caroli J, Rocken M, Breuninger H. Analysis of risk factors determining prognosis of cutaneous squamous-cell carcinoma: a prospective study. Lancet Oncol. 2008 Aug;9(8):713-20. doi: 10.1016/S1470-2045(08)70178-5. Epub 2008 Jul 9.

    PubMed 18617440
  • Brougham ND, Dennett ER, Cameron R, Tan ST. The incidence of metastasis from cutaneous squamous cell carcinoma and the impact of its risk factors. J Surg Oncol. 2012 Dec;106(7):811-5. doi: 10.1002/jso.23155. Epub 2012 May 16.

    PubMed 22592943
  • Schmults CD, Karia PS, Carter JB, Han J, Qureshi AA. Factors predictive of recurrence and death from cutaneous squamous cell carcinoma: a 10-year, single-institution cohort study. JAMA Dermatol. 2013 May;149(5):541-7. doi: 10.1001/jamadermatol.2013.2139.

    PubMed 23677079
  • Muzic JG, Schmitt AR, Wright AC, Alniemi DT, Zubair AS, Olazagasti Lourido JM, Sosa Seda IM, Weaver AL, Baum CL. Incidence and Trends of Basal Cell Carcinoma and Cutaneous Squamous Cell Carcinoma: A Population-Based Study in Olmsted County, Minnesota, 2000 to 2010. Mayo Clin Proc. 2017 Jun;92(6):890-898. doi: 10.1016/j.mayocp.2017.02.015. Epub 2017 May 15.

    PubMed 28522111
  • van Hoeve JC, Vernooij RWM, Fiander M, Nieboer P, Siesling S, Rotter T. Effects of oncological care pathways in primary and secondary care on patient, professional and health systems outcomes: a systematic review and meta-analysis. Syst Rev. 2020 Oct 25;9(1):246. doi: 10.1186/s13643-020-01498-0.

    PubMed 33100227
  • Bath-Hextall F, Nalubega S, Evans C. The needs and experiences of patients with skin cancer: a qualitative systematic review with metasynthesis. Br J Dermatol. 2017 Sep;177(3):666-687. doi: 10.1111/bjd.15148. Epub 2017 Feb 22.

    PubMed 27775838
  • Winterbottom A, Harcourt D. Patients' experience of the diagnosis and treatment of skin cancer. J Adv Nurs. 2004 Nov;48(3):226-33. doi: 10.1111/j.1365-2648.2004.03191.x.

    PubMed 15488036
  • Bath-Hextall F, Jenkinson C, Kumar A, Leonardi-Bee J, Perkins W, Cox K, Glazebrook C. Longitudinal, mixed method study to look at the experiences and knowledge of non melanoma skin cancer from diagnosis to one year. BMC Dermatol. 2013 Oct 29;13:13. doi: 10.1186/1471-5945-13-13.

    PubMed 24164857

Questions about this trial

What is this clinical trial studying?

An observational study of Cutaneous Squamous Cell Carcinoma and Cutaneous Squamous Cell Carcinoma of the Head and Neck, run by Maastricht University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Themes patients (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06046625, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.

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