Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Nil: Nil
Intervention4: Nil: Nil
Intervention5: Nil: Nil
Intervention6: Nil: Nil
Intervention7: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
NIL
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients willing to participate 2.Patients with histo-pathologically proven malignancy. 3.Patients who are started on opioid therapy and switched from weak opioid (e.g.Tramadol) to stronger opioids(e.g.Morphine,Fentanyl,Buprenorphine,Tapentadol,Methadone)and escalation of ongoing opioid dose. 4. ECOG performance status-0-2 5.Able to communicate in English, Hindi, Marathi and capable of providing written informed consent for questionnaire administration 6.Availability(Either physical or Virtual) for follow up as per study schedule
Exclusion criteria
Exclusion criteria: 1.Patients with gastrointestinal obstruction or suspected obstruction 2.Patients with recent history of (less than 28 days ) gastrointestinal surgery or radiation therapy to gastro-intestinal tract 3.Patients who are known cases of Inflammatory bowel disease,Irritable bowel syndrome or other gastro-intestinal disorders affecting gastro-intestinal motility. 4.Patients with neurological condition affecting bowel function. 5.Patients with Pre-existing psychiatric disorders or cognitive impairments that prevent the patient from comprehending the questionnaire. 6.Pregnancy and lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of OIC will be calculated as the proportion or frequency of patients meeting Rome IV criteriaTimepoint: Incidence of OIC will be calculated at 1 week and 2 week | — |
Secondary
| Measure | Time frame |
|---|---|
| The Mean change in BFI score between patients who develop OIC and those who do not develop OIC.Timepoint: At the end of first week and second week.;The diagnostic accuracy of the BFI score against the ROME-IV criteria will be assessed using standard diagnostic performance measures (sensitivity, specificity, predictive values, and accuracy)Timepoint: At the end of first week and second week.;Incidence of OIC (ROME IV or BFI-defined) relative to the opioid factors, and median time to OIC onset after opioid exposure shift.Timepoint: At the end of first week and second week.;The associated confounding factors will be expressed with the help of Adjusted Odds Ratios (AORs) derived from a multivariable logistic regression model. This will quantify the independent influence of each non-opioid factor on OIC incidence, after accounting for opioid dose and other relevant factors.Timepoint: At the end of first week and second week.;Patterns of laxative initiation (prophylactic vs. rescue), effectiveness (measured by subsequent bowel outcomes), and overall self-management approach prevalence in the cohort.Timepoint: At the end of first week and second week. | — |
Countries
India
Contacts
Public ContactDR Raghu S Thota
TATA Memorial Hospital
Outcome results
None listed