| CTRI Number |
CTRI/2026/01/101949 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Mixed methods Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to Assess the Needs of Caregivers in Advanced Cancer Patients |
|
Scientific Title of Study
|
Needs Assessment in Caregivers of Terminally Ill Cancer Patients - A Mixed Methods Study |
| 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 Ananya D Bhat |
| Designation |
DNB Resident Doctor |
| Affiliation |
Basavatarakam Indo American Cancer Hospital and Research Institute |
| Address |
Pain and Palliative Medicine Ward, 3rd floor, 2nd block, Road No.10, Banjara Hills, Hyderabad, Telangana
Hyderabad
TELANGANA
500034
India |
| Phone |
9535629483 |
| Fax |
|
| Email |
ananyadbhat99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praneeth Suvvari |
| Designation |
Consultant and guide |
| Affiliation |
Basavatarakam Indo American Cancer Hospital and Research Institute |
| Address |
Pain and Palliative Medicine ward, 3rd floor, 2nd block,Road No.10, Banjara Hills, Hyderabad, Telangana
Hyderabad
TELANGANA
500034
India |
| Phone |
9814686999 |
| Fax |
|
| Email |
praneethsuv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praneeth Suvvari |
| Designation |
Consultant and guide |
| Affiliation |
Basavatarakam Indo American Cancer Hospital and Research Institute |
| Address |
Pain and Palliative Medicine ward, 3rd floor, 2nd block,Road No.10, Banjara Hills, Hyderabad, Telangana
Hyderabad
TELANGANA
500034
India |
| Phone |
9814686999 |
| Fax |
|
| Email |
praneethsuv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Basavatarakam Indo American Cancer Hospital and Research Institute |
|
|
Primary Sponsor
|
| Name |
Dr Ananya D Bhat |
| Address |
Basavatarakam Indo American Cancer Hospital and Research Institute,Road No.10, Banjara Hills, Hyderabad, Telangana |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ananya D Bhat |
Basavatarakam Indo American Cancer Hospital and Research Institute |
Department of Pain and Palliative Medicine, Basavatarakam Indo American Cancer Hospital and Research Institute, Road No. 10, Banjara Hills, Hyderabad, Telangana
Hyderabad
TELANGANA |
9535629483
ananyadbhat99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Caregivers of Terminally ill Cancer patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
(1)Patient is above 18 years of age suffering from terminal cancer (2)Caregivers aged above the age of 18 years (3)Patients must be diagnosed with terminal cancer(4)Able to understand English(5)Provided informed consent for participation in both qualitative and quantitative parts
|
|
| ExclusionCriteria |
| Details |
(1)Paid or professional caregivers (nurses, home health aides)(2)Caregivers unwilling or unable to complete interviews or questionnaires (due to time constraints or fatigue)(3)Cognitive impairment or major psychiatric illness in the caregiver (as documented in medical records or caregiver self-report).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of caregiver needs using validated questionnaires |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Exploration of caregiver experiences and perceived unmet needs through semi structured interviews |
Till thematic saturation is reached |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
01/03/2026 |
| 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="1"
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
|
This is an observational mixed-methods study designed to assess caregiver needs in patients receiving palliative care. The quantitative component involves assessment using validated caregiver need scales, while the qualitative component includes semi structured interviews to explore caregiver experiences and unmet needs. Findings from both components will be integrated to provide a comprehensive understanding of caregiver needs. |