NCT06046625

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

April 4, 2025

Status Verified

March 1, 2025

Enrollment Period

2 years

First QC Date

August 18, 2023

Last Update Submit

April 2, 2025

Conditions

Keywords

Patient experiencePatients needSemi-structuredProfessionalsExperienceNeeds

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Association themes and patient/tumor characteristics

    Through study completion, an average of 1 year

  • Association themes and professional characteristics

    Through study completion, an average of 1 year

Study Arms (1)

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

Interventions

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.

Head-neck cutaneous Squamous cell carcinomas

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • \- patients who are cognitively impaired for participation in an interview

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center+

Maastricht, Netherlands

Location

Related Publications (19)

  • 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.

    PMID: 33572373BACKGROUND
  • 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.

    PMID: 32113941BACKGROUND
  • 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.

    PMID: 22264671BACKGROUND
  • 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.

    PMID: 25428226BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 29332704BACKGROUND
  • 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.

    PMID: 19713116BACKGROUND
  • 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.

    PMID: 18617440BACKGROUND
  • 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.

    PMID: 22592943BACKGROUND
  • 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.

    PMID: 23677079BACKGROUND
  • 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.

    PMID: 28522111BACKGROUND
  • 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.

    PMID: 33100227BACKGROUND
  • 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.

    PMID: 27775838BACKGROUND
  • 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.

    PMID: 15488036BACKGROUND
  • 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.

    PMID: 24164857BACKGROUND
  • 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.

    PMID: 29927480BACKGROUND
  • Abedini R, Nasimi M, Noormohammad Pour P, Moghtadaie A, Tohidinik HR. Quality of Life in Patients with Non-melanoma Skin Cancer: Implications for Healthcare Education Services and Supports. J Cancer Educ. 2019 Aug;34(4):755-759. doi: 10.1007/s13187-018-1368-y.

    PMID: 29705894BACKGROUND
  • Hamilton DW, Heaven B, Thomson RG, Wilson JA, Exley C. Multidisciplinary team decision-making in cancer and the absent patient: a qualitative study. BMJ Open. 2016 Jul 21;6(7):e012559. doi: 10.1136/bmjopen-2016-012559.

    PMID: 27443554BACKGROUND
  • Hahlweg P, Hoffmann J, Harter M, Frosch DL, Elwyn G, Scholl I. In Absentia: An Exploratory Study of How Patients Are Considered in Multidisciplinary Cancer Team Meetings. PLoS One. 2015 Oct 6;10(10):e0139921. doi: 10.1371/journal.pone.0139921. eCollection 2015.

    PMID: 26441328BACKGROUND

MeSH Terms

Conditions

Carcinoma, Squamous CellSquamous Cell Carcinoma of Head and NeckSkin NeoplasmsPatient SatisfactionPatient Preference

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellHead and Neck NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • K Mosterd, MD, PhD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2023

First Posted

September 21, 2023

Study Start

November 1, 2021

Primary Completion

November 1, 2023

Study Completion

June 1, 2025

Last Updated

April 4, 2025

Record last verified: 2025-03

Locations