- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06046625
Needs and Preferences of Patients With Head-neck Cutaneous SCC
The Needs and Preferences of Patients With High-risk Cutaneous Squamous Cell Carcinomas in the Head Neck Region: a Qualitative Approach
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
-
Maastricht, Netherlands
- Maastricht University Medical Center+
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Through study completion, an average of 1 year
|
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.
|
Through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Through study completion, an average of 1 year
|
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).
|
Through study completion, an average of 1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: K Mosterd, MD, PhD, Maastricht University Medical Center
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- METC 2021-2765
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Squamous Cell Carcinoma of the Head and Neck
-
National Cancer Institute (NCI)Not yet recruitingStage II Squamous Cell Carcinoma of the Head and Neck | Stage III Squamous Cell Carcinoma of the Head and Neck | Stage IV Squamous Cell Carcinoma of the Head and NeckUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingStage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 | Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 | Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck | Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck | Stage...United States
-
Bristol-Myers SquibbActive, not recruitingSquamous Cell Carcinoma of the Head and Neck; Head and Neck Cancer; Head and Neck Carcinoma; Cancer of the Head and NeckFrance
-
Washington University School of MedicineCelgene CorporationActive, not recruitingHead and Neck Cancer | Squamous Cell Carcinoma of the Head and Neck | Cancer of Head and Neck | Neoplasms, Head and Neck | Cancer of the Head and Neck | Carcinoma, Squamous Cell of the Head and NeckUnited States
-
Arnaud Bewley, MDNational Cancer Institute (NCI); Genentech, Inc.TerminatedStage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 | Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck | Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and NeckUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)RecruitingRecurrent Head and Neck Squamous Cell Carcinoma | Advanced Head and Neck Squamous Cell Carcinoma | Metastatic Head-and-neck Squamous-cell Carcinoma | Locally Advanced Head and Neck Squamous Cell Carcinoma | Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck | Stage IV Cutaneous...United States
-
University of Southern CaliforniaSanofiTerminatedCarcinoma of the Head and NeckUnited States
-
Hi-Q Marine Biotech International, Ltd.RecruitingSquamous Cell Carcinomas of the Head and NeckTaiwan
-
Eben RosenthalNational Cancer Institute (NCI)CompletedHead and Neck Cancer | Head and Neck Squamous Cell Carcinoma | Squamous Cell Carcinoma of the Head and Neck (SCCHN)United States
-
Queensland HealthMerck Sharp & Dohme LLCRecruitingHead and Neck Cancer | Cutaneous Squamous Cell Carcinoma of the Head and NeckAustralia
Clinical Trials on Regular care with additional administration of a semi-structured interview
-
Rsocialform - Geriatria, LdaCompletedDepressive Disorder | Depression | Neurocognitive Disorders | DementiaPortugal
-
University of MiamiNational Cancer Institute (NCI); LUNGevity FoundationNot yet recruitingHead and Neck CancerUnited States
-
Maastricht University Medical CenterRecruitingQuality of Life | Satisfaction, Patient | Squamous Cell Carcinoma of the Head and Neck | Squamous Cell Carcinoma of Head and Neck | Skin Cancer | Squamous Cell Carcinomas | Squamous Cell Carcinoma of the Skin | Cutaneous Squamous Cell Carcinoma of the Head and Neck | Cutaneous Squamous Cell Carcinoma | High-Risk CancerNetherlands
-
University of WashingtonNational Cancer Institute (NCI)RecruitingDepression | Hematopoietic and Lymphoid Cell Neoplasm | Malignant Solid NeoplasmUnited States
-
Nantes University HospitalCR2TI, INSERM, UMR1064RecruitingBipolar Disorder I | Bipolar Disorder II | Schizoaffective Disorder, Depressive TypeFrance
-
Centre hospitalier de Ville-Evrard, FranceRecruiting
-
Centre Hospitalier Metropole SavoieCompletedCOVID-19 | Stress Disorders, Post-TraumaticFrance
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedAcute Lymphoblastic Leukemia | Adult B Acute Lymphoblastic Leukemia | Childhood B Acute Lymphoblastic LeukemiaUnited States, Canada, Australia, New Zealand, Switzerland