Cachexia, Cancer, Psychosocial Functioning, Treatment Side Effects
Conditions
Brief summary
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
Interventions
None listed
Sponsors
Hacettepe University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or older * Having undergone a CT scan (at the L3 level) prior to treatment * No severe mental disorder and able to communicate effectively * Provided written informed consent
Exclusion criteria
* Did not provide written informed consent * Patients deemed unsuitable by the physician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body composition evaluation | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cachexia and psychosocial factors evaluation | Throughout 6 months of follow-up. | 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. |
| Drug Related Problems | Throughout 6 months of follow-up. | 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). |
Countries
Turkey (Türkiye)
Contacts
Primary Contactİzgi BAYRAKTAR, PhD (c)- Lecturer
Backup ContactAygin Ekincioglu, Prof.Dr. -Head of department
Outcome results
None listed