Evaluation of Skin Health and Quality of Life in Patients Receiving Anti-PD1/PDL1/CTLA4 or Cyclin-dependent Kinase (CDK) Inhibitors.

Study Overview
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Brief Summary
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The study aim to investigate the relationship between cutaneous adverse events and quality of life in patients taking immune check point inhibitor or cyclin-dependent kinase (CDK) 4 and 6 inhibitors by two steps. In the first one, it will be investigated the relationship between the skin toxicity related to the use selected therapies and the quality of life of patients already receiving these therapies for treatment of their cancer. In the second one, it will be evaluated the relationship between skin toxicity and quality of life over three months of treatment in patients initially naïve for selected therapies. Cancer included in the analysis are NSCLC, renal cancer, gastric cancer, breast cancer, bladder cancer, melanoma, squamous cell carcinoma of the head and neck.

Official Title
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Evaluation of Skin Health and Quality of Life in Patients Receiving Anticancer Therapies Based on Monoclonal Antibody Anti-PD1/PDL1/CTLA4 or Cyclin-dependent Kinase (CDK) Inhibitors

Conditions
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Lung Cancer, Breast Cancer, Kidney Cancer, Bladder Cancer, Gastric Cancer, Skin Cancer, Melanoma, Head Neck Cancer

Intervention / Treatment
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* Other: EQ-5D-5L questionnaire
* Other: FACT-G (Functional Assessment of Cancer Therapy - General)
* Other: FACT-EGFRI-18 (Functional Assessment of Cancer Therapy - Epidermal Growth Factor Inhibitors 18 Item)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (for all Groups) Age ≥ 18 years. Histological diagnosis of solid tumor. Patient able to complete the questionnaires submitted during the study. Signed written informed consent. (for Group I) Patients already under treatment for at least three months with anti-PD1/PDL1/ CTLA4 or cyclin-dependent kinase (CDK) inhibitors for any type of cancer. Treatment considered for each cancer are only those approved by AIFA for each tumor. (for Group II) Patients eligible for treatment with anti-PD1/PDL1/ CTLA4 or cyclin-dependent kinase (CDK) inhibitors for any type of cancer. Treatment considered for each cancer are only those approved by AIFA for each tumor. Exclusion Criteria (for all Groups): Age < 18 y.o. Skin diseases or alterations present before the beginning of anti-PD1/PDL1 or cyclin-dependent kinase (CDK) inhibitors. Chronic use of steroids. Previous psychiatric disorders or patients taking antidepressant. Refusal to sign written informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>All patients affected by solid tumors already in treatment with anti-PD1/PDL1 or cyclin-dependent kinase (CDK) inhibitors. | Other: EQ-5D-5L questionnaire<br>* Quality of life evaluation questionnaire<br>Other: FACT-G (Functional Assessment of Cancer Therapy - General)<br>* Quality of life evaluation questionnaire<br>Other: FACT-EGFRI-18 (Functional Assessment of Cancer Therapy - Epidermal Growth Factor Inhibitors 18 Item)<br>* Self reported evaluation of cutaneous toxicity questionnaire.<br>|
| Group 2<br>All patients affected by solid tumors already eligible for treatment with anti-PD1/PDL1 or cyclin-dependent kinase (CDK) inhibitors. | Other: EQ-5D-5L questionnaire<br>* Quality of life evaluation questionnaire<br>Other: FACT-G (Functional Assessment of Cancer Therapy - General)<br>* Quality of life evaluation questionnaire<br>Other: FACT-EGFRI-18 (Functional Assessment of Cancer Therapy - Epidermal Growth Factor Inhibitors 18 Item)<br>* Self reported evaluation of cutaneous toxicity questionnaire.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life in patients undergoing anti-PD1/PDL1/CTLA4 or cyclin-dependent kinase (CDK) inhibitors. | To investigate the correlation between the skin toxicity related to the use of monoclonal antibody against the PD1/PDL1/CTLA4 or to cyclin-dependent kinase (CDK) inhibitors and the quality of life. | 18 months | 
| Quality of life during therapy with anti-PD1/PDL1/CTLA4 or cyclin-dependent kinase (CDK) inhibitors. | To evaluate the correlation between skin toxicity and quality of life over three months of treatment in patients initially naïve for monoclonal antibody anti-PD1/PDL1/CTLA4 or with cyclin-dependent kinase (CDK) inhibitors. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Role of gender | To describe differences in quality of life based on gender. | 18 months | 
| Role of therapy | To describe differences in quality of life based on type of therapy received (Immunotherapy vs CDK inhibitors). | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immunotherapy, cyclin-dependent kinase (CDK) inhibitors, cutaneous toxicity