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Evaluation of the effects of body composition, psychosocial factors, and drug-related problems on clinical progression (such as toxicity, treatment response, and quality of life) in cancer patients treated with immune checkpoint inhibitors
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| Measure | Description | Time Frame |
|---|---|---|
| Body composition evaluation | Body Composition Parameters Description: Muscle area, muscle index, muscle density, lean body mass, and combined indices derived from routine abdominal imaging at the L3 vertebral level. Unit of measure: cm², cm²/m², Hounsfield units (HU), kilograms. Tool: Routine clinical imaging analysis. | Patient recruitment is planned to occur over a 6-month period. Each participant will be followed for a maximum duration of 6 months from the initiation of immunotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Cachexia and psychosocial factors evaluation | Cachexia Risk Scores Description: Composite scores reflecting cachexia status, based on multidimensional clinical and biochemical indicators. Unit of measure: Scoring system Tool: Validated cachexia scoring system. Psychosocial Factor Scores Description: Scores representing levels of depression, anxiety, stress, and distress, assessed through validated self-report questionnaires. Unit of measure: Questionnaire scores (scale ranges such as 0-21 or 0-10). Tool: Validated patient-reported outcome measures. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of adult patients initiating immune checkpoint inhibitor therapy (ipilimumab, nivolumab, pembrolizumab, atezolizumab, or avelumab) at the Medical Oncology Outpatient Clinic.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| İzgi BAYRAKTAR, PhD (c)- Lecturer | Contact | +905342996472 | izgibayraktar@gmail.com | |
| Aygin Ekincioglu, Prof.Dr. -Head of department | Contact | +90 532 355 07 46 | aygin@hacettepe.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hacettepe University Faculty of Pharmacy, Department of Clinical Pharmacy | Recruiting | Ankara | Altındağ | 06100 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D002100 | Cachexia |
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
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| Throughout 6 months of follow-up. |
| Drug Related Problems | Drug-Related Problems (DRPs) Description: Number and type of drug-related problems identified during treatment follow-up. Unit of measure: Count (number of problems per patient). Tool: Pharmaceutical Care Network Europe (PCNE) classification system. Immune-Related Adverse Events (irAEs) Description: Incidence and severity of immune-related adverse events occurring during immunotherapy. Unit of measure: Percentage of patients; severity graded 1-5. Tool: Common Terminology Criteria for Adverse Events (CTCAE v5.0). | Throughout 6 months of follow-up. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |