Geriatric assessment based interventions in older patients with cancer

Phase 3

Recruiting

Conditions: Neoplasm of unspecified behavior of other specified sites,

Registration Number: CTRI/2023/08/056958

Lead Sponsor: AIIMS

Brief Summary: Indian population is aging with increased percentage of older age population. This further increases the prevalence of chronic, non-communicable diseases, of which malignancies are one. Two important aims of treatment in older patients with cancer are increasing survival and improving their health-related quality of life (HRQoL). The management of older cancer population is challenging in view of increased number of comorbidities and increased age-related issues, which can be assessed by comprehensive geriatric assessment. Previous studies have shown that with time HRQoL changes in these patients and baseline quality of life (QoL) parameters are better prognostic markers than other clinical variables. It has been seen in multiple studies that multidisciplinary interventions improve HRQoL scores, but other studies have shown conflicting results with conflicting effect on survival. While patientâ€™s communication and satisfactions seemed to improve, with these interventions. But these interventions and their results were not uniform in the studies.

With the hypothesis that geriatric assessment (GA) based personalized interventions will improve the HRQoL of the older patients with cancer, this study has been planned. Other objectives would be to observe the impact of these interventions on survival, toxicity of the treatment, patient satisfaction, muscle mass and strength, and molecular levels. This study would be done in treatment naÃ¯ve patients with solid malignancies to maintain homogeneity. In this prospective randomized two group comparative study, patient would be divided in two groups, of which one would be given GA based personalized interventions by the multidisciplinary team (planned by the investigator) and then would be send to the medical oncology team for standard of care treatment. While the other group would undergo geriatric assessment and with the results would be send to medical oncology team for standard of care, and further referrals to super-specialty would be decided by treating oncologist. These patients would be followed for one year to observe their survival, patient satisfaction, treatment toxicity, muscle mass and strength and change in biomarker levels.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 170

Inclusion Criteria

Patients age more than 65 years with a diagnosis of solid malignant neoplasm of any stage, ECOG 0-2, able to give written informed consent, treatment naÃ¯ve older patients with cancer.

Exclusion Criteria

Patient denying participation, ECOG 3 and 4, hematological malignancies.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in HRQoL by Global health status scale of EORTC QLQ C-30	At baseline and 6 months

Secondary Outcome Measures

Name	Time	Method
change in other HRQoL parameters on EORTC QLQ C-30 & FACT-G at 3 & 6 months	Overall survival at 1 year

Trial Locations

Locations (1): All India Institute of Medical sciences
🇮🇳
South, DELHI, India
All India Institute of Medical sciences
🇮🇳South, DELHI, India
Dr Nidhi Soni
Principal investigator
8527118534
nidhisoni1962@gmail.com