study for comprehensive assessment of elderly cancer patients undergoing treatment for cancer
- Conditions
- Neoplasm of unspecified behavior of unspecified site,
- Registration Number
- CTRI/2022/06/043215
- Lead Sponsor
- Apollo Proton Cancer Centre
- Brief Summary
**PROTOCOL SYNOPSIS**
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|**B****ackground and Rationale**
The treatment of geriatric cancer patients has to be cognizant of their vulnerabilities. Oncologic interventions require to be tailor made to the chronological as well as biological age of patients as well as to their social situation. Geriatric assessment helps to identify areas of special concern as well as to design interventions to address them.
There is limited information regarding vulnerabilities among the elderly cancer patient in India especially with reference to patients undergoing radiotherapy and surgery. This study aims to fill this gap.
|**G****eneral aim**
Pilot study to record comprehensive evaluation of elderly patients before treatment decisions and to prospectively evaluate the association of G8 assessment with assessment-based intervention, clinical outcomes and treatment-related severe toxicity
|**P****rimary objective (endpoint)**
· Identification of vulnerable geriatric cancer patients using G8.
|**S****econdary objectives (endpoints)**
· Demographic details, comorbidities and status as per G8 screening tool.
· Prospective record of geriatric assessment-based interventions in patients identified as vulnerable.
· Prospective record of treatment modifications at initiation due to elderly / G8 screening status of patient (0,3 months).
· Treatment breaks/ reduced intensity/omission
· Prolongation of treatment time
· Hospital admission
· ICU admission
· Falls
· Deterioration in G8 score
· Toxicity (Acute and late toxicity according to CTCAE version 5.0 criteria at baseline and 3 months)
· Quality of life EORTC QLQ-C30, QLQ-ELD14 at 0 and 3 months
|**D****esign**
Prospective registry-based study
|**P****opulation**
All patients above 65 years registered at APCC for cancer diagnosis/treatment
|**S****t****atistical considerations**
Descriptive statistical analysis will be applied to routine demographic data collected, expressed as frequency for categorical variables. Chi-square test and Fisher’s exact test will be used for comparisons. Kaplan Meir curves will be used to summarize the time to event endpoints over time. Log-rank test will be used to test for differences in the OS for dichotomous variables. Factors significant in the univariate analysis will be tested by multivariate analysis using the Cox proportional hazard model.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 30
Cancer patients aged ≥ 65 years reporting to APCC and being considered for treatment at APCC.
- Cancer patients on routine follow-up after completion of treatment 2.
- Patients not registered at APCC 3.
- Patients unable to fulfil the voluntary informed consent requirements.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Identification of vulnerable geriatric cancer patients using G8. 1. Identification of vulnerable geriatric cancer patients using G8.
- Secondary Outcome Measures
Name Time Method Demographic details, comorbidities and status as per G8 screening tool baseline, 3 months Prospective record of geriatric assessment-based interventions in patients identified as vulnerable baseline, 3 months Prospective record of treatment modifications at initiation due to elderly / G8 screening status of patient baseline, 3 months Toxicity (Acute and late toxicity according to CTCAE version 5.0 criteria) baseline, 3 months Quality of life EORCT QLQ-C30, QLQ-ELD14 at 0 and 3 months baseline, 3 months
Trial Locations
- Locations (1)
Apollo Proton Cancer Centre
🇮🇳Chennai, TAMIL NADU, India
Apollo Proton Cancer Centre🇮🇳Chennai, TAMIL NADU, IndiaSapna NangiaPrincipal investigator9971866069sapna_nangia@outlook.com