Decisional Conflicts, Health-related QoL and Satisfaction With Care in High-risk cSCC in the Head-neck Region

Trial Title: Decisional Conflicts, Health-related QoL and Satisfaction With Care in High-risk cSCC in the Head-neck Region

NCT ID: NCT05482880

Condition: 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

Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck

Conditions: Keywords:
High-risk cutaneous squamous cell carcinoma
Health-related quality of life
Decisional conflicts
Satisfaction with care
Head-neck region
Multidisciplinary care

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Other
Intervention name: Regular care with additionally administration of questionnaires
Description: Patients receiving regular care. In addition, validated questionnaires are administered at two measurement points: 1. after the multidisciplinary consultation, a baseline questionnaire*, the decision conflict scale and the EQ-5D-5L questionnaire are administered by phone. 2. 1 month after completion of the treatment program (care pathway) the EQ-5D-5L, the BaSQoL and the EORTC IN-PATSAT32 questionnaires will be administered by phone. Completing the questionnaires takes about 30 minutes each time. *Baseline questionnaire: gender, age, marital status, education level, World Health Organization (WHO) performance status, presence of informal care, stage and treatment of cSCC, history of skin cancer, presence of current other skin cancer, and average travel time to hospital.
Arm group label: head-neck cutaneous Squamous cell carcinomas

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.

Criteria for eligibility:

Study pop:
Patients are selected by the treating physicians from multidisciplinary consultation in the secondary/tertiary centers Maastricht UMC+ and Radboud UMC.

Sampling method: Non-Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Radboud UMC

Address:
City: Nijmegen
Country: Netherlands

Status: Recruiting

Contact:
Last name: S.F.K. Lubeek, MD, PhD

Facility:
Name: Maastricht University Medical Center +

Address:
City: Maastricht
Country: Netherlands

Status: Recruiting

Contact:
Last name: Emmy Cruts, MD

Start date: February 28, 2022

Completion date: December 2023

Lead sponsor:
Agency: Maastricht University Medical Center
Agency class: Other

Source: Maastricht University Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05482880