| CTRI Number |
CTRI/2024/10/075773 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Quality of Life and Emotional Well-being in Patients with cancer metastasis associated compression of spinal cord |
|
Scientific Title of Study
|
Assessment of Quality of Life and Emotional well-being in Patients diagnosed with Metastatic Spinal Cord Compression Presenting to the Palliative Medicine Department in a Tertiary Care Centre: A Prospective Observational 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 Anjali P Govind |
| Designation |
Junior Resident , AIIMS New Delhi |
| Affiliation |
AIIMS , New Delhi |
| Address |
Palliative Care Unit Room No. 154 DR BRA IRCH, All India Institute
Of Medical Sciences Ansari Nagar New Delhi
South West
DELHI
110029
India
New Delhi
DELHI
110029
India |
| Phone |
7022889298 |
| Fax |
|
| Email |
agovind.964@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anuja Pandit |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
Palliative Care Unit Room No. 154 DR BRA IRCH, All India Institute
Of Medical Sciences Ansari Nagar New Delhi
South West
DELHI
110029
India
New Delhi
DELHI
110029
India |
| Phone |
9710030457 |
| Fax |
|
| Email |
anujapandit@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjali P Govind |
| Designation |
Junior resident , Palliative Medicine |
| Affiliation |
AIIMS, New Delhi |
| Address |
Palliative Care Unit Room No. 154 DR BRA IRCH, All India Institute
Of Medical Sciences Ansari Nagar New Delhi
South West
DELHI
110029
India
New Delhi
DELHI
110029
India |
| Phone |
7022889298 |
| Fax |
|
| Email |
agovind.964@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Onco-Anaesthesia And Palliative Medicine, DR BRA IRCH, AIIMS, New Delhi
PIN code: 110029
New Delhi
India |
|
|
Primary Sponsor
|
| Name |
Dr BRA IRCH AIIMS New Delhi |
| Address |
DR BRA IRCH All India Institute Of Medical Sciences Ansari Nagar
New Delhi 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Anjali P Govind |
All India Institue of Medical Sciences, New Delhi |
Room 154 1st floor , DR BRA IRCH
New Delhi 110029
South West
DELHI
New Delhi
DELHI |
7022889298
agovind.964@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee For Post Graduate Research, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil
Not available |
Nil
Not available |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patients diagnosed with metastatic spinal cord compression presenting to the Palliative Medicine department during the time period of the study.
All consenting adult patients
|
|
| ExclusionCriteria |
| Details |
1.Patients who do not understand Hindi or English
2.Patients in altered mental sensorium
3. Patients with age less than 18 years
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess emotional well being in patients diagnosed with MSCC at the time of presentation, at 10 days & at 1 month in a tertiary cancer care centre in India |
10 days & 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the quality of life in MSCC patients diagnosed at the time of presentation, 10 days & 1 month in a tertiary cancer centre in India
To assess the survival, performance status, pain, mobility and place of care in patients diagnosed with MSCC at the time of presentation, 10 days and 1 month
|
10 days & 1 month |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
29/10/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
After getting clearance from the Institute Ethics Committee, patients attending the pain and palliative care department with a diagnosis of Metastatic spinal cord compression will be recruited in the study. Patients will be explained about the study protocol and informed consent will be taken. The patient’s demographic data including the age, gender, primary cancer, treatment history, duration of disease, details of analgesics, specific symptoms of MSCC , if any treatment was given for the same etc. will be recorded in a predesigned proforma. Patient will be asked in detail about the various complaints which impact the QOL or the outcome using a questionnaire-based validated scale of European Organization for Research and Treatment of Cancer general cancer QOL Score 30 (EORTC QLQ C-30) .Emotional well being will be assessed using Hospital anxiety and depression score. Patients will continue to receive therapy deemed necessary by the oncologists. The treatment being received will be noted. All patients recruited in the study will be assessed at baseline using EORTC-QLQ 30, HADS, KPS and NRS, and also on their follow up visits at 10 days and 1st month. The patient’s treatment and analgesics will also be recorded at their follow up visits. Their mobility, bladder control, place of care will also be noted. Complete privacy and anonymity will be maintained while filling up the questionnaire.
Statistical analysis Data will be analysed using STATA 14 and SPSS 16. Baseline, patient characteristics will be summarised with mean (SD) or median (25th – 75th percentile) for continuous as well as ordinal variable, Number in percentage or categorical. The proportion of well being (Score >/=9) at 1 month will be reported with percentage along with 95% confidence interval. If data of well being score or Quality of Life is normally distributed then we apply the linear mix model with suitable covariance structure. Else non parametric method Friedman followed by Wilcoxon signed rank test. Similarly, for NRS score and performance status at different point will be assessed using Friedman followed by Wilcoxon signed rank and p value adjusted as per Boneferroni correction. P value <0.05 will be considered as significant.
|