Clinical trial NCT05482880: Decisional Conflicts, Health-related QoL and Satisfaction With Care in High-risk cSCC in the Head-neck Region
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cutaneous Squamous Cell Carcinoma
Cutaneous Squamous Cell Carcinoma of the Head and Neck
Squamous Cell Carcinomas
Squamous Cell Carcinoma of Head and Neck
Squamous Cell Carcinoma of the Skin
Squamous Cell Carcinoma of the Head and Neck
Skin Cancer
High-Risk Cancer
Quality of Life
Satisfaction, Patient
Keywords: High-risk cutaneous squamous cell carcinoma
Health-related quality of life
Decisional conflicts
Satisfaction with care
Head-neck region
Multidisciplinary care
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are selected by the treating physicians from multidisciplinary consultation in the secondary/tertiary centers Maastricht UMC+ and Radboud UMC.

Brief summary: 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.

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.

Patient-reported outcomes and health related quality of life (HRQoL) are important outcomes in the care for high-risk cSCCs in the head-neck region (HNcSCCs). Previous research is limited regarding the impact of cSCCs on QoL in patients with high-risk HNcSCCs , as is research on decision conflicts in the choice of treatment. The PROFILES registry (Arts, 2019) investigated QoL and satisfaction with care in 215 patients with keratinocyte carcinomas in the head-neck region. However, the majority of the patients had basal cell carcinoma (81%); only 23 patients had cSCC. Besides, no distinction was made in high or low risk cSCC. Finally, quality of life and patient satisfaction questionnaires were not administered until at least one year after diagnosis.

Other studies of QoL in cSCC patients do not distinguish stage and/or location of the tumor, involve small study populations, or only use oncological questionnaires rather than disease-specific questionnaires.

In conclusion, there is little scientific research on health related quality of life, decision conflicts in the choice of treatment and satisfaction with care in specific patients with high-risk HNcSCCs.

Eligibility criteria: Inclusion Criteria:

* patients diagnosed with a T2 to T4 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

Primary outcomes:
measure: Decisional conflict
timeFrame: At the start (before treatment) of the care pathway.
measure: Health-related quality of life
timeFrame: At the start (before treatment) of the care pathway.
measure: Health-related quality of life
timeFrame: At 1 month after completion of the care pathway.
measure: Health-related quality of life
timeFrame: At 1 month after completion of the care pathway.
measure: Satisfaction with care
timeFrame: Once during the care pathway: 1 month after completion of the care pathway.
Secondary outcomes:
measure: Difference in decisional conflict outcomes between centers
timeFrame: At the start (before treatment) of the care pathway.
measure: Difference in health-related quality of life outcomes between centers
timeFrame: At the start (before treatment) of the care pathway.
measure: Difference in health-related quality of life outcomes between centers
timeFrame: At 1 month after completion of the care pathway.
measure: Difference in health-related quality of life outcomes between centers
timeFrame: At 1 month after completion of the care pathway.
measure: Difference in satisfaction with care outcomes between centers
timeFrame: At 1 month after completion of the care pathway.
measure: Change from baseline health-related quality of life after treatment
timeFrame: Twice during the care pathway: at the start (before treatment) and 1 month after completion of the care pathway.
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud UMC
state: Gelderland
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center +
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: K Mosterd, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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