SkinHealthOnco: Evaluation of Skin Health and Quality of Life in Patients Receiving Anti-PD1/PDL1/CTLA4 or Cyclin-dependent Kinase (CDK) Inhibitors.
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Group 1 All patients affected by solid tumors already in treatment with anti-PD1/PDL1 or cyclin-dependent kinase (CDK) inhibitors. |
Other: EQ-5D-5L questionnaire
Quality of life evaluation questionnaire
Other: FACT-G (Functional Assessment of Cancer Therapy - General)
Quality of life evaluation questionnaire
Other: FACT-EGFRI-18 (Functional Assessment of Cancer Therapy - Epidermal Growth Factor Inhibitors 18 Item)
Self reported evaluation of cutaneous toxicity questionnaire.
|
| Group 2 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
Quality of life evaluation questionnaire
Other: FACT-G (Functional Assessment of Cancer Therapy - General)
Quality of life evaluation questionnaire
Other: FACT-EGFRI-18 (Functional Assessment of Cancer Therapy - Epidermal Growth Factor Inhibitors 18 Item)
Self reported evaluation of cutaneous toxicity questionnaire.
|
Outcome Measures
Primary Outcome Measures
- Quality of life in patients undergoing anti-PD1/PDL1/CTLA4 or cyclin-dependent kinase (CDK) inhibitors. [18 months]
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.
- Quality of life during therapy with anti-PD1/PDL1/CTLA4 or cyclin-dependent kinase (CDK) inhibitors. [18 months]
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.
Secondary Outcome Measures
- Role of gender [18 months]
To describe differences in quality of life based on gender.
- Role of therapy [18 months]
To describe differences in quality of life based on type of therapy received (Immunotherapy vs CDK inhibitors).
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Roberto Iacovelli | Roma | Italy | 00168 |
Sponsors and Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 5455