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

Not yet recruiting

Brief Summary: It is well known that patients diagnosed withcancers experience significant levels of distress. Surveys have shown that20-50% of patients show significant distress.

A landmark randomised studyconcluded that patients with metastatic nonâ€“small-cell lungcancer, early palliative care ledto significant improvements in both quality oflife and mood when compared to patients receiving standard care. [1]

Various distress screening tools have been used to objectively detectsignificant levels of distress. The Edmonton Symptom assessment scale has beenwidely used in for many years. [ 2 . 4 , 5 ] The NCCN Distress thermometerscale has also been recently found to be a simple method to identify patientsat high risk for distress. [ 3]

The use of these distress screening tools is expected to help screen andidentify cancer patients with significant psychosocial as well as physicaldistress, so that early initiation of supportive care can be implemented. Thistimely intervention could lead to improvement in well being and quality of lifeof patient.

Recruitment & Eligibility

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.

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)	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 RT	3 months
-To determine most frequent distressing symptom	End of treatment
-To determine mean timing of maximum distress from baseline to 6 months post RT	6 months
-To determine the mean change in Anxiety & depression score from baseline to 1 / 3 months post RT	3 months
-To determine proportion of patients with moderate to severe distress during radiation therapy	End of treatment
-To determine the proportion of asymptomatic patients on radiation therapy requiring supportive care based on distress score changes	End of treatment
-To determine the mean change in symptom score because of supportive care using ESAS tool	6 months

Locations (1): Amrita Institute of Medical Sciences
🇮🇳
Ernakulam, KERALA, India
Amrita Institute of Medical Sciences
🇮🇳Ernakulam, KERALA, India
Dr Debnarayan Dutta
Principal investigator
9884234290
duttadeb07@gmail.com