Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Advanced ovarian cancer for upfront surgery or after NACT 2. Preoperative schedule that allows from at least 3 weeks for upfront surgery and upto three months for interval debulking surgery 3. Treatment naive patients 4. Eastern Cooperative Oncology Group Performance Status of up to 2.
Exclusion criteria
Exclusion criteria: 1. Significant comorbidities or limitation of locomotion that prohibit the patient to perform prehabilitation activities 2. Emergency surgeries 3. Surgeries by minimally invasive approach (laparoscopy or robotics) 4. Patients suffering from depression and major psychiatric illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Functional capacity assessment using cardiopulmonary testing by six minute walk test (6 MWT) and pulmonary function tests using spirometry. 2. Nutritional assessment by serum albumin levels, body mass index, and hand grip strength test 3. Quality of life assessment using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ- C30) 4. To measure intraoperative anaesthetic parameters - peak pressure, plateau pressure, lactate levels, tidal volume, temperature, urine output, ionotropic requirement, cardiac ejection fraction, problems during weaning off (extubation failure and immediate need for re-intubation and post extubation stridor) 5. To measure intraoperative surgical outcomes - duration of surgery in minutes , blood loss, transfusion of blood and blood products, cytoreductive outcomes, surgical complexity score.Timepoint: 3 weeks to 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients with adherence to prehabilitation program as measured by asking them to maintain and enter daily records of exercises, diet and pshycological activities in a provided chart if patients are at home or recording in the proforma if hospitalised. 2. Adverse events of prehabilitation - injuries during exercise, gastrointestinal symptoms (nausea, vomiting, diarrhoea), withdrawal symptoms due to cessation of smoking (will take consultation from psychiatry team for opinion and management if needed)Timepoint: 3 weeks to 3 months | — |
Countries
India
Contacts
All India Institute of Medical Sciences, Rishikesh