Clinical trial · Observational
Decisional Conflicts, Health-related QoL and Satisfaction With Care in High-risk cSCC in the Head-neck Region
Decisional Conflicts, Health-related Quality of Life and Satisfaction With Care in High-risk Cutaneous Squamous Cell Carcinoma in the Head-neck Region: Validated Questionnaires
NCT05482880CI-TRIAL-00100191completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patient reported outcomes in patients with high-risk cutaneous squamous cell carcinoma in the head-neck region are an important part of the complex care for these patients. Health-related quality of life, decision conflicts in the choice of treatment and satisfaction with care have not yet been sufficiently studied in this patient group.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous Squamous Cell Carcinoma | Skin Squamous Cell Carcinoma | ALIAS | 0.90 |
| Cutaneous Squamous Cell Carcinoma of the Head and Neck | Head and Neck Cutaneous Squamous Cell Carcinoma | ALIAS | 0.90 |
| High-Risk Cancer | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Satisfaction, Patient | — | UNRESOLVED | — |
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
| Squamous Cell Carcinoma of Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
| Squamous Cell Carcinoma of the Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
| Squamous Cell Carcinoma of the Skin | Skin Squamous Cell Carcinoma |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Regular care with additionally administration of questionnaires | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- head-neck cutaneous Squamous cell carcinomas
- description
- Patients with high risk cutaneous squamous cell carcinoma of the head-neck area receiving regular, multidisciplinary care.
- interventionNames
- Other: Regular care with additionally administration of questionnaires
Primary outcomes (5)
- measure
- Decisional conflict
- timeFrame
- At the start (before treatment) of the care pathway.
- description
- Decisional conflicts expressed as mean total and domain scores on the Decisional Conflict Scale (DCS) questionnaire. The DCS questionnaire consist of 16 items related to decision conflicts. Items are given a score value of 0 (strongly agree), 1 (agree), 2 (neither agree or disagree), 3 (disagree) and 4 (strongly disagree). The total score can be calculated by summarize all scores, dividing by 16 and then multiplying by 25. The total score ranges from 0 to 100. A higher score correlates with a higher decisional conflict. The 5 domain subscores are: uncertainty (3 items), informed (3 items), values clarity (3 items), support (3 items) and effective decision (4 items). The subscores can be calculated by summarize the (3 or 4) items, dividing by the number of items (3 or 4) and then multiplying by 25. The subscores range from 0 to 100 where a higher score correlates with a higher decisional conflict.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patients diagnosed with a cutaneous squamous cell carcinoma located in the head-neck area (including patients with metastatic or recurrence disease) * requiring a multidisciplinary approach * assessed at the department of dermatology of Maastricht UMC+ or Radboud UMC OR discussed in the multidisciplinary consultation in Maastricht UMC+ or Radboud UMC * and for which treatment of the tumor (primary tumor or metastatic/recurrence) takes places in the Maastricht UMC+ of Radboud UMC * willing to participate voluntarily in the study Exclusion Criteria: * patients younger than 18 years * patients with inadequate understanding of the Dutch language * patients with cognitive impairment or otherwise unable to complete the questionnaires
References
Publications (13)
- BACKGROUNDStratigos 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 32113941
- BACKGROUNDStratigos AJ, Garbe C, Dessinioti C, Lebbe C, Bataille V, Bastholt L, Dreno B, Concetta Fargnoli M, Forsea AM, Frenard C, Harwood CA, Hauschild A, Hoeller C, Kandolf-Sekulovic L, Kaufmann R, Kelleners-Smeets NWJ, 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 2. Treatment. Eur J Cancer. 2020 Mar;128:83-102. doi: 10.1016/j.ejca.2020.01.008. Epub 2020 Feb 26. PMID 32113942
- BACKGROUNDKallini 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 25428226
- BACKGROUNDQue 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 29332704
- BACKGROUNDMourouzis 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.