Lung Cancer, Breast Cancer, Kidney Cancer, Bladder Cancer, Gastric Cancer, Skin Cancer, Melanoma, Head Neck Cancer
Conditions
Keywords
immunotherapy, cyclin-dependent kinase (CDK) inhibitors, cutaneous toxicity
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.
Interventions
Quality of life evaluation questionnaire
OTHERFACT-G (Functional Assessment of Cancer Therapy - General)
Quality of life evaluation questionnaire
OTHERFACT-EGFRI-18 (Functional Assessment of Cancer Therapy - Epidermal Growth Factor Inhibitors 18 Item)
Self reported evaluation of cutaneous toxicity questionnaire.
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(for all Groups) 1. Age ≥ 18 years. 2. Histological diagnosis of solid tumor. 3. Patient able to complete the questionnaires submitted during the study. 4. 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): 1. Age \< 18 y.o. 2. Skin diseases or alterations present before the beginning of anti-PD1/PDL1 or cyclin-dependent kinase (CDK) inhibitors. 3. Chronic use of steroids. 4. Previous psychiatric disorders or patients taking antidepressant. 5. Refusal to sign written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life in patients undergoing anti-PD1/PDL1/CTLA4 or cyclin-dependent kinase (CDK) inhibitors evaluated by EQ-5D-5L questionnaire. | 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. Skin toxicity will be evaluated by the physician and graded based ob CTCAE v 5.0. The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can image' and 'The worst health you can image'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement. |
| Quality of life during therapy with anti-PD1/PDL1/CTLA4 or cyclin-dependent kinase (CDK) inhibitors by FACT-G scale | 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. Skin toxicity will be evaluated by the physician and graded based ob CTCAE v 5.0. The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being. For all FACIT measures, higher scores are better than lower scores. |
| Quality of life during therapy with anti-PD1/PDL1/CTLA4 or cyclin-dependent kinase (CDK) inhibitors by FACT-EGFRI-18 scale. For all FACIT measures, higher scores are better than lower scores. | 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. Skin toxicity will be evaluated by the physician and graded based ob CTCAE v 5.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Role of gender | 18 months | To describe differences in quality of life based on gender. The incidence and grade of skin toxicity based ob CTCAE v 5.0, will be estimated based on sex. Similarly the correlation of skin toxicity with quality of life evaluated by EQ-5D-5L, FACT-G, FACT-EGFRI-18 measures will be estimated by sex. |
| Role of therapy | 18 months | To describe differences in quality of life based on type of therapy received (Immunotherapy vs CDK inhibitors). The incidence and grade of skin toxicity based ob CTCAE v 5.0, will be estimated based on type of therapy. Similarly the correlation of skin toxicity with quality of life evaluated by EQ-5D-5L, FACT-G, FACT-EGFRI-18 measures will be estimated by type of therapy. |
Countries
Italy
Contacts
Primary ContactRoberto Iacovelli
Outcome results
None listed