| CTRI Number |
CTRI/2025/10/095729 [Registered on: 08/10/2025] Trial Registered Prospectively |
| Last Modified On: |
14/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Unmet Care Needs in Elderly Cancer Patients in India |
|
Scientific Title of Study
|
Unmet Supportive Care Needs among Indian Geriatric Cancer Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vanita Noronha |
| Designation |
Professor |
| Affiliation |
Tata Memorial Centre |
| Address |
Tata Memorial Centre,, Homi Bhabha Building,303, 3rd floor, Department of Medical Oncology, Dr. Ernest Borges Road, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
09769328047 |
| Fax |
-- |
| Email |
vanita.noronha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vanita Noronha |
| Designation |
Professor |
| Affiliation |
Tata Memorial Centre |
| Address |
Tata Memorial Centre,, Homi Bhabha Building,303, 3rd floor, Department of Medical Oncology, Dr. Ernest Borges Road, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
09769328047 |
| Fax |
-- |
| Email |
vanita.noronha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vanita Noronha |
| Designation |
Professor |
| Affiliation |
Tata Memorial Centre |
| Address |
Tata Memorial Centre,, Homi Bhabha Building,303, 3rd floor, Department of Medical Oncology, Dr. Ernest Borges Road, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
09769328047 |
| Fax |
-- |
| Email |
vanita.noronha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital,Dr. E. Borges Road, Parel, Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital,Dr. E. Borges Road, Parel, Mumbai 400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mahati Chittem |
Indian Institute of Technology Hyderabad (IITH) |
Department of Liberal Arts
Room number: 308
Sangareddy, Kandi 502285
Telangana
Hyderabad
TELANGANA |
897890111
mahati@la.iith.ac.in |
| Dr Akhil Kapoor |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre |
Department of Medical Oncology, OPD No. 28, Ground floor, DNT Block, Sundar Bagiya, Near Nariya Gate, Banaras Hindu University Campus, Varanasi (U.P.) 221005 India
Varanasi
UTTAR PRADESH |
7597364554
kapoorakhil1987@gmail.com |
| Dr Varun Rajan |
Medical Trust Hospital, Kochi |
Department of Medical Oncology,
East Annexe 4th floor, M.G.Road,
Cochin, Kerala -682016
Ernakulam
KERALA |
9446805593
varunacme@yahoo.co.in |
| Dr Vanita Noronha |
Tata Memorial Centre |
Tata Memorial Centre,, Homi Bhabha Building,303, 3rd floor, Department of Medical Oncology, Dr. Ernest Borges Road, Parel, Mumbai
400012
Mumbai
MAHARASHTRA |
02224176214
vanita.noronha@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee, MTH |
Approved |
| Institutional Ethics Committee-I |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Quantitative Component (Questionnaires) & Interview |
1. Quantitative Component (Questionnaires): Camberwell Assessment of Need Short Appraisal Schedule – Patient (CANSAS-P) Measures met, unmet, and under-met supportive care needs across domains (physical, psychological, social, daily living). Medical Outcomes Study Social Support Survey (MOS-SSS) Evaluates perceived social support (emotional, informational, tangible, affectionate). EORTC QLQ-ELD14 Measures health-related quality of life specific to elderly cancer patients. 2. Qualitative Component (Interview): Semi-structured, one-on-one interviews exploring patients’ lived experiences regarding logistical, financial, informational, emotional, and social needs. Conducted in hospital settings by trained researchers. Audio-recorded, transcribed, and analyzed using Thematic Network Analysis (TNA).
1. Self-administered or interviewer-assisted survey (approx. 25–30 minutes). 2. Approx. 45–60 minutes total (questionnaire + interview). |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Geriatric patients aged 60 years and over, currently being treated for any type of cancer
at a hospital and are at any stage of their treatment.
2. Patients who are fluent in spoken Hindi, English or local/regional language (e.g.,
Marathi, Bihari). |
|
| ExclusionCriteria |
| Details |
1. Patients who are partially aware or unaware of their diagnosis.
2. Patients who score 23 or lower on standardized cognitive assessments, indicating cognitive
impairment.
3. Patients who have an active untreated psychiatric disorder. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To identify and assess the unmet supportive care needs of geriatric cancer patients and their association with health-related quality of life (HRQoL).
Specific variables measured:
Number and type of unmet needs across physical, emotional, informational, social, and financial domains (measured using Camberwell Assessment of Need Short Appraisal Schedule – Patient).
HRQoL scores (measured using EORTC QLQ-ELD14).
Social support levels (measured using MOS Social Support Survey). |
at baseline & during follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cancer among older adults in India presents unique challenges, including
late diagnoses, limited specialized care, and difficulties in accessing
treatment. Older cancer patients often face not just the physical burden of
cancer but also emotional distress, financial strain, and social isolation.
Many of these patients have unmet supportive care needshelp that goes beyond medical
treatment to improve their quality of life.
Older cancer patients represent the largest group in oncology, yet they
often experience worse outcomes due to gaps in care. They may struggle with
daily activities, managing side effects, and coping with mental health issues
like depression and anxiety. Having access to information, financial
assistance, transportation, and emotional support can significantly improve
their well-being. However, many of these needs remain unmet, leading to lower
treatment adherence and poorer quality of life.
This study aims to:
- Identify the unmet
supportive care needs of older cancer patients.
- Examine how these needs
impact their healthrelated quality of life.
- Provide insights to
improve care and develop better healthcare policies.
The study will include 92 geriatric cancer patients from hospitals in
India.
Participants will answer questionnaires about their physical, emotional,
and social well-being.
Some participants will also take part in interviews to share their
experiences in greater detail.
Statistical and qualitative methods will be used to analyze the findings.
The study will help identify critical areas
where older cancer patients need more support. By understanding these needs,
healthcare providers can design better services, improve patient outcomes, and
advocate for supportive care policies at a national level. |