| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- 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.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [aanandini@gmail.com].
- 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.
- 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 = | | ÂAssociated 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 | | | Total 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 | SHS | Patient 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. | SHS | Patient 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. | SHS | Patient 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. | SHS | Patient Seeks Help | | | | | | | | | | | | |