Association of lifestyle factors with clinical outcomes in newly diagnosed non metastatic colorectal cancer and the role of lifestyle intervention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- JIPMER
- Enrollment
- 110
- Locations
- 1
Study Overview
Brief Summary
This 2-year prospective study at JIPMER aims to assess lifestyle factors and implement a structured lifestyle intervention in patients with non-metastatic (stage I–III) colorectal cancer. In the first phase, eligible patients will be recruited and evaluated using a structured proforma capturing clinical, anthropometric, and metabolic data, along with the Composite Lifestyle Mapping Index (CLeMI) questionnaire to assess diet, physical activity, sedentary behavior, substance use, stress, and sleep. Quality of life will be measured using the EORTC QLQ-C30 and CR-29 tools. Participants will be followed at 3 and 6 months for lifestyle reassessment, quality-of-life changes, and clinical outcomes including recurrence, disease-free survival, and overall survival. The second phase is a pilot study of the Cancer Survivorship Healthy Lifestyle Implementation Program (CshLIP)—a culturally adapted lifestyle modification program based on AICR recommendations. Thirty treated colorectal cancer patients will receive individualized lifestyle counselling, reinforced through periodic telephonic follow-up and in-person review at 3 months. The primary outcomes will be adherence to the intervention and improvement in lifestyle scores at 3 and 6 months
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 90.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •PART-I Inclusion Criteria: 1.Newly diagnosed Early/Locally advanced Stage I to III CRC patients with histopathologically confirmed diagnosis 2.Adults (more than or equal to 18 years) 3.ECOG less than or equal to 3 PART-II Inclusion criteria: 1.Non- metastatic colorectal cancer patients who have completed treatment within the past 2 to 8 weeks 2.Age more than or equal to 18 years 3.ECOG PS more than or equal to 2.
Exclusion Criteria
- •PART-I 1.Non-consenting patients 2.Patients who cannot read or write Tamil or English 3.Pregnant or Lactating Women 4.Patients with Previous Malignancies that may confound the results PART-II 1.Patients with uncontrolled diabetes, severe cardiovascular disease, or advanced chronic kidney/liver disease that may impact lifestyle changes.
- •2.Patients with dementia, psychiatric disorders, or conditions affecting their ability to adhere to lifestyle interventions.
- •3.Non- consenting patients 4.Patients who cannot read or write Tamil or English.
Investigators
Prem Venkatt
JIPMER