| CTRI Number |
CTRI/2025/08/093634 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
26/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding needs and experience of patients with advanced cancer and their carers who receive palliative care at home |
|
Scientific Title of Study
|
Patient and caregiver needs and perspectives during transition to domiciliary palliative care in advanced cancer: 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 Shadhikha K |
| Designation |
Junior Resident |
| Affiliation |
Christian Medical College Vellore |
| Address |
Department of Palliative Medicine
Christian Medical College
Ida Scudder Road,
Vellore
Tamil Nadu-632004
Telephone: 04162283159
Fax number : 04162232035
Vellore
TAMIL NADU
632004
India |
| Phone |
9655377834 |
| Fax |
04162232035 |
| Email |
shadhikha.k.pg@cmcvellore.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jenifer Jeba S |
| Designation |
Professor and Head |
| Affiliation |
Christian Medical College Vellore |
| Address |
Department of Palliative Medicine
Christian Medical College
Ida Scudder Road,
Vellore
Tamil Nadu-632004
Telephone: 04162283159
Fax number : 04162232035
Vellore
TAMIL NADU
632004
India |
| Phone |
9443019383 |
| Fax |
04162232035 |
| Email |
jenifer.jeba@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jenifer Jeba S |
| Designation |
Professor and Head |
| Affiliation |
Christian Medical College Vellore |
| Address |
Department of Palliative Medicine
Christian Medical College
Ida Scudder Road,
Vellore
Tamil Nadu-632004
Telephone: 04162283159
Fax number : 04162232035
Vellore
TAMIL NADU
632004
India |
| Phone |
9443019383 |
| Fax |
04162232035 |
| Email |
jenifer.jeba@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| Christian medical college
Ida Scudder Road
Vellore
Tamil Nadu,India -632004 |
|
|
Primary Sponsor
|
| Name |
Dr. Shadhikha. K |
| Address |
Department of Palliative Medicine
Christian Medical College,
Ida Scudder road
Vellore
Tamil Nadu-632004
|
| 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 Shadhikha K |
Christian Medical College, Vellore |
Department of Palliative Medicine
Christian Medical College
Ida Scudder road
Vellore
Tamil Nadu-632004
Vellore
TAMIL NADU |
09655377834
04162232035
shadhikha.k.pg@cmcvellore.ac.in |
|
Details of Ethics Committee
Modification(s)
|
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C800||Disseminated malignant neoplasm, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
FOR PATIENTS:
1.Diagnosis of advanced cancer
2.Patients who will continue to receive palliative care services from the Department of Palliative Medicine, Christian Medical College Vellore
3.Patients who are physically able and have the cognition to participate in interviews /or complete questionnaires.
4.Have the mental capacity to understand details of the study and make informed decision and provide informed consent.
FOR CAREGIVERS:
1.Identified as the family carer of the patient.
2.Able and willing to provide informed consent
3.Cognitively and physically able to participate in interviews or complete questionnaires.
|
|
| ExclusionCriteria |
| Details |
FOR PATIENTS:
1.Patients who are physically or cognitively unable to participate in interviews or complete questionnaires.
FOR CAREGIVERS:
1.Age below 18 years
2.Professional caregivers or paid home care staff.
3.Cognitively and physically unable to participate in interviews or complete questionnaires.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the caregiver burden of family carers of advanced cancer patients at the point of transition to domiciliary palliative care. |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the symptom burden of patients with advanced cancer during the transition to domiciliary palliative care.
2.To assess the quality of life of patients with advanced cancer during the transition to domiciliary palliative care.
3.To assess the psychological distress in patients with advanced cancer during the transition to domiciliary palliative care.
4.To assess the distress of the patients & family carers with advanced cancer & the contributing factors during the transition to domiciliary palliative care. |
At baseline |
5.Identify the patient & any caregiver- related determinants that contribute to patient’s quality of life or psychological distress during the transition to domiciliary palliative care.
6.To identify any patient-related or caregiver related determinants that contribute to caregiver burden
7.To understand the unmet needs, perspectives, & experiences of family caregivers during the transition to domiciliary palliative care caregivers during the transition to domiciliary palliative care.
8.To understand the unmet needs, perspectives & experiences of patients with advanced cancer during the transition to domiciliary palliative care
|
At baseline |
|
|
Target Sample Size
|
Total Sample Size="153"
Sample Size from India="153"
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)
|
03/09/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The transition from institutional to home-based care is a critical juncture in the palliative care journey for patients with advanced cancer and their caregivers. This phase often has significant physical, emotional, and logistical challenges. Understanding the perspectives of both patients and caregivers during this transition is essential for delivering holistic supportive care that aligns with their values, meets their evolving needs, and improves overall quality of life. Despite its importance, there is limited research addressing the combined needs and experiences of both groups during this period. This study aims to explore the needs, preferences, and experiences of patients with advanced cancer and their primary caregivers at the point of transition to domiciliary palliative care. It adopts a cross-sectional mixed-methods design with quantitative and qualitative components. The qualitative arm will involve semi-structured interviews for which purposive sampling will be done for patients and caregivers with representation of different patients and caregiver factors will be considered to explore their lived experiences. The quantitative component will utilize validated assessment tools to evaluate symptom burden, psychological distress, and caregiver burden. Data will be collected during the transitional phase, either in inpatient or outpatient settings within the department of palliative medicine, to capture immediate perspectives and concerns. By identifying unmet needs and expectations, this study seeks to inform improvements in the continuity and quality of palliative care delivery at home. The findings are expected to guide the development of transition-sensitive practices and support systems, ultimately fostering more responsive and compassionate care. This research has the potential to bridge gaps between hospital and domiciliary care, enhancing support for both patients and their families during the final stages of illness. |