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CTRI Number  CTRI/2021/09/036681 [Registered on: 21/09/2021] Trial Registered Prospectively
Last Modified On: 07/07/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Testing the accuracy, usefulness and possibility of a screening tool to identify Serious Health-related Suffering across few tertiary health care institutions across India 
Scientific Title of Study   Field testing the validity and feasibility of the NCG-SHS screening Tool for Serious Health-related Suffering, at tertiary health care institutions across India 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
13755  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nandini Vallath 
Designation  Consultant 
Affiliation  Tata Memorial Centre 
Address  NCG, ROOM 821, HBB, Tata Memorial Centre,

Mumbai
MAHARASHTRA
400012
India 
Phone  9167526030  
Fax    
Email  aanandini@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nandini Vallath 
Designation  Consultant 
Affiliation  Tata Memorial Centre 
Address  NCG, ROOM 821, HBB, Tata Memorial Centre,

Mumbai
MAHARASHTRA
400012
India 
Phone  9167526030  
Fax    
Email  aanandini@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nandini Vallath 
Designation  Consultant 
Affiliation  Tata Memorial Centre 
Address  NCG, ROOM 821, HBB, Tata Memorial Centre,

Mumbai
MAHARASHTRA
400012
India 
Phone  9167526030  
Fax    
Email  aanandini@gmail.com  
 
Source of Monetary or Material Support  
NATIONAL CANCER GRID INDIA 
 
Primary Sponsor  
Name  NATIONAL CANCER GRID INDIA 
Address  TATA MEMORIAL CENTRE, DR E BORGES ROAD, PAREL, MUMBAI 400012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 9  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Medha Sugara Associate Professor of Surgical Oncology  St.Johns Medical College Hospital  Department of surgical Oncology, Oncology centre, 2nd floor Sarjapur Road Bangalore-560034
Bangalore
KARNATAKA 
080-22065907

medha.sugara@gmail.com 
K Pavithran  Amrita Institute of Medical Sciences  Amrita Institute of Medical Sciences, Brahmasthanam, Edappally North, Kochi, Kerala - 682024
Kozhikode
KERALA 
9895367090

pavithrank@aims.amrita.edu 
Jenifer Jeba  Christian Medical College   Vellore, Tamil Nadu 632004
Vellore
TAMIL NADU 
9443019383

jenifer.jeba@cmcvellore.ac.in 
Vidya Viswanath  Homi Bhabha Cancer Hospital and Research Centre  Visakhapatnam, Andhra Pradesh 530053
Visakhapatnam
ANDHRA PRADESH 
9848498412

drvidya21@gmail.com 
KRITHIKA RAO  Kasturba Medical College  Tiger Circle Road, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA 
9619902263

krithika.rao@manipal.edu 
Gayatri Palat  MNJ Institute of Oncology & Regional Cancer Centre  Red Hills, Lakidikapul, Hyderabad- 500004
Hyderabad
TELANGANA 
9985480614

gpalat@gmail.com 
KALPANA BALAKRISHNAN  Regional cancer centre, Cancer Institute (WIA) Adyar  W Canal Bank Rd, Gandhi Nagar, Adyar, Chennai, Tamil Nadu 600020
Chennai
TAMIL NADU 
9840158777

kalpana.balakrishnan@gmail.com 
Indranil Mallick  Tata Medical Center  Newtown, Kolkata, West Bengal 700160
Kolkata
WEST BENGAL 
9831171235

indranil.mallick@tmckolkata.com 
JAYITA DEODHAR  Tata Memorial Hospital  Dr E Borges Road, Parel, Mumbai, Maharashtra 400012
Mumbai
MAHARASHTRA 
9892358023

jukd2000@yahoo.co.uk 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 11  
Name of Committee  Approval Status 
IEC Amrita Institute of Medical Sciences  Approved 
IEC Homi Bhabha Cancer Hospital and Research Centre  Approved 
IEC KMC MAHE  Approved 
IEC MAX Healthcare  Approved 
IEC Meherbai Tata Main Hospital  Approved 
IEC MNJ Institute of Oncology & Regional Cancer Centre  Approved 
IEC Regional cancer centre, Cancer Institute (WIA) Adyar  Approved 
IEC St Johns Medical College  Approved 
IEC Tata Medical Center  Approved 
IEC TMH  Approved 
IRB CMC VELLORE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  • Adult patients (>18 years of age) with cancer
• Able to comprehend English language
• Able to use, understand and fill out the tool (android application/ paper form)
 
 
ExclusionCriteria 
Details  Not willing to participate 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• Feasibility of the use of NCG SHS Screening tool among English speaking cancer patients
• Validity of the NCG SHS Screening tool to identify Serious Health-related Suffering among cancer patients
 
single, at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
The challenges perceived by the patient and the assessor in the use of the NCG SHS tool.
The adequacy of training material and training offered in the use of the NCG SHS tool. 
single, at baseline 
 
Target Sample Size   Total Sample Size="256"
Sample Size from India="256" 
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   Phase 2 
Date of First Enrollment (India)   01/10/2021 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [aanandini@gmail.com].

  6. For how long will this data be available start date provided 01-05-2022 and end date provided 30-04-2023?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The primary goal of palliative care is alleviation of suffering; physical, psycho-social and spiritual. Serious health-related suffering (SHS) as defined by the Lancet Commission on Palliative Care and Pain Relief (2018) indicates suffering associated with a need for palliative care, and estimated the global burden using mortality data for 20 conditions, adjusted for the prevalence of both physical and psychosocial symptoms. The Global Atlas of Palliative Care 2nd Edition, 2020 maps and reports a very high burden of suffering in the LMICs (993 per 100,000) (World health organization- WHPCA). However, little has been done in assessment of suffering and capturing this in a holistic way. Cancer is one of the major contributors of Serious Health-related Suffering (SHR). The first active step to alleviate SHS is to screen cancer patients for this. NCG SHS Tool is envisaged as a screening tool to identify the major distresses in cancer patients who reach healthcare settings and help trigger appropriate care-responses to address them. The field test aims to pilot the NCG SHS Tool (annexure 1) to check the feasibility and validity. The NCG SHS screening tool will be administered to English speaking patients from the Medical Oncology Department (OP and IP settings). They will also be interviewed by a trained psychologist as a comparable standard. This will be done on a minimum of 256 participants across ten cancer-care centers in India. The feasibility, validity and usefulness of this NCG SHS tool will be studied. The assessor and respondent burden, right personnel and setting for administration of the tool and the training material and delivery to administer this tool will also be evaluated.

Annexure 1: NCG-SHS Tool for Field Testing - https://efficiency365.com/shs/

NCG - SHS Tool for Field Testing

Domains of Health-related Suffering

Not at all

Score 0

A little

 

Score 1

A lot

 

Score 2

Domain Score

Associated with your health, do you suffer physically? With pain/ breathing difficulty/ vomiting/ constipation/ weakness / feeding/loose motion/ bleeding/ itching/ wounds /difficulty with senses (see, hear, smell, touch, taste) / difficulty moving/ other issues

 

 

 

P =

Associated with your health, do you suffer emotionally? Feeling sad/ unloved / worried/ angry/ lonely/ difficulty sleeping/ confused/ poor memory / other issues

 

 

 

E =

Associated with your health, do you suffer due to issues with family/ relationships/ friends/ community/ feeling isolated/ difficulty at work/ difficulty with hospital visits/ difficulty communicating/ other issues

 

 

 

S =

­Associated with your health, do you suffer due to feeling punished/ fearful/ shame / guilty / angry with God / no meaning in life/ disconnected / other issues

 

 

 

Sp =

Associated with your health, do you suffer due to lost job/ stopped studies/ stopped working/ loan/ debt / sold property/sold assets/migrated out / other issues

 

 

 

F =

Is there Presence of Health-related Suffering?  

P + E + S + Sp + F

Total Score

 > 2    

Total Score

< 2   

Domains: P- Physical; E – Emotional; S – Relations/Social; Sp – Spiritual; F- Financial

 

Checkbox CrossedTotal Score  < 2   à SHS

The screening for SHS is continued at pre-decided intervals, as per the Institutional policy

 

Total Score  > 2   

Check for Seriousness of the health-related suffering by asking the 2nd level questions

 

A)   Has this suffering limited you from doing what you need to do, for > 14 days over the last 30 days? e.g. self-care (feed, bathe, dress, walk, toilet); care for others; communicate; learn /think/perform duties; sleep / rest?                   Yes / No

B)   Ask the patient – Do you seek additional help for your concerns?

 

Yes / No

 

 

Responses to the 2nd level questions

Screening Outcome to be recorded on the Case Sheet

 

1.    o    YES to both A and B   

Notify the treating team and activate further evaluation and care-pathways as decided by the department/institution

Checkbox Checked SHS

Checkbox CheckedPatient Seeks Help

 

2.    o    NO to A and YES to B

Notify the treating team, so they may evaluate further and activate care-pathways as decided by the administration.

Checkbox Checked SHS

Checkbox CheckedPatient Seeks Help

 

3.    o    YES to A and NO to B  

Educate patient/family about availability of support and encourage to seek support when they need; empower with information.

Checkbox CheckedSHS

Checkbox CrossedPatient Seeks Help

 

4.    o    NO to both A and B

The screening for SHS is continued at pre-decided intervals, as per the Institutional policy.

Checkbox CrossedSHS

Checkbox CrossedPatient Seeks Help

 


 

 
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