Study evaluating Symptom and Distress screening tools in initiating early supportive care in cancer patients treated with curative radiation therapy

Not Applicable

• Conditions: Health Condition 1: C00-D49- Neoplasms

• Registration Number: CTRI/2022/01/039478
• Lead Sponsor: Debnarayan Dutta

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

All consecutive patients diagnosed with non metastatic cancer of any site planned for treatment with radical intent radiation therapy

Exclusion Criteria

Previous radiation therapy

Patients planned for treatment with 10 fractions or less

Patients with multiple distant metastases

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine mean change in Total ESAS-r score from baseline to RT completion or follow up visit (3 month)Timepoint: 3 month after RT completion

Secondary Outcome Measures

Name	Time	Method
-To determine mean change in QOL scores (FACT- G , TOI scores) from baseline to 1 or 3 months post RTTimepoint: 3 months;-To determine mean timing of maximum distress from baseline to 6 months post RTTimepoint: 6 months;-To determine most frequent distressing symptomTimepoint: End of treatment;-To determine proportion of patients with moderate to severe distress during radiation therapyTimepoint: End of treatment;-To determine the mean change in Anxiety & depression score from baseline to 1 / 3 months post RTTimepoint: 3 months;-To determine the mean change in symptom score because of supportive care using ESAS toolTimepoint: 6 months;-To determine the proportion of asymptomatic patients on radiation therapy requiring supportive care based on distress score changesTimepoint: End of treatment