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CTRI Number  CTRI/2021/09/036567 [Registered on: 16/09/2021] Trial Registered Prospectively
Last Modified On: 15/09/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Effectiveness of project EMPATHY on the improvement of Quality Of Life in the patients with advance cancer - A Randomized Control Trial 
Scientific Title of Study   Effectiveness of project EMPATHY on the improvement of Quality Of Life(QOL) in patients with advance cancer - A Randomized Control Trial 
Trial Acronym  EMPATHY 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arati Hota 
Designation  Psycho-oncologist 
Affiliation  Bhagwan Mahaveer Cancer Hospital and Research Centre 
Address  Psychology Department Room No-119, 1st Floor Bhagwan Mahaveer Cancer Hospital and Research Centre JLN Marg Jaipur

Jaipur
RAJASTHAN
302017
India 
Phone  9672986322  
Fax    
Email  arati.hota5@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Arati Hota 
Designation  Psycho-oncologist 
Affiliation  Bhagwan Mahaveer Cancer Hospital and Research Centre 
Address  Psychology Department Room No. 119, 1st Floor Bhagwan Mahaveer Cancer Hospital and Research Centre JLN Marg Jaipur

Jaipur
RAJASTHAN
302017
India 
Phone  9672986322  
Fax    
Email  arati.hota5@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Arati Hota 
Designation  Psycho-oncologist 
Affiliation  Bhagwan Mahaveer Cancer Hospital and Research Centre 
Address  Psychology Department Room No-119, 1st floor Bhagwan Mahaveer Cancer Hospital and Research Centre JLN Marg Jaipur

Jaipur
RAJASTHAN
302017
India 
Phone  9672986322  
Fax    
Email  arati.hota5@gmail.com  
 
Source of Monetary or Material Support  
Bhagwan Mahaveer Cancer Hospital and Research Centre  
 
Primary Sponsor  
Name  The study is not sponsored by anybody or organization 
Address  Not Applicable 
Type of Sponsor  Other [This study is not sponsored study] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Arati Hota  Bhagwan Mahaveer Cancer Hospital and Research Centre  Psychology Department Room No-119, 1st floor JLN Marg, Jaipur-302017
Jaipur
RAJASTHAN 
9672986322

arati.hota5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee BMCHRC Jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J948||Other specified pleural conditions,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  A. Physical symptoms( Examination & documentation) B. Psycho education C. Prognostic Discussion D. Relaxation Training   • Involves information giving and receiving • Discussion of concerns • Problem Solving • Coping skill training • Expression of emotion • Simple Breathing Exercise ( 2-3-5) /3times/5 mints/day • PMR ( 20-30 mints) /3 days/Week • Pleasant nature imagery exercise ( 15-20 mints) every day (Morning ) • Assessment of the problems (Role changes, physical limitations, family problem, pain, loss of hair, sexual problem etc.) • Setting up GOAL • Generating solution • Choosing solution • Implementation and evaluation of outcomes Physical Symptoms Examination- 10-15 minutes Psycho education - 30-40 minutes session Prognostic discussion - 25-30 minutes Relaxation Training 20-30 minutes  
Intervention  Physical Symptoms Examination  Duration - 10-15 minutes/each visit Total Duration - 3 months Visit schedule: Day-1,Day- 7,Day-15 , Day- 30, Day-45, Day-60, Day-75, Day-90 Unscheduled visit will be documented if any Symptoms - Pain, Fatigue, Breathlessness, Vomiting etc. will be checked and documented in Numerical Rating Scale ( NRS) in each visit  
Intervention  Prognostic Discussion  Duration : 25-30 minutes Details : 1. Discussion points are symptoms severity 2.Further treatment 3. Prognosis 4. Noticeable points for deterioration of symptoms and overall general condition 5. How the patient can be managed at home with common symptoms at advance stage Total Duration - 3 months Day-1 , Day-30, Day-60, Day-90 Unscheduled visit will be documented if any 
Intervention  Psycho education  Duration : 30-40 minutes session Total Duration - 3 months Visit schedule: Day-1,Day- 7,Day-15 , Day- 30, Day-45, Day-60, Day-75, Day-90 Unscheduled visit will be documented if any Details : 1.Involves information giving and receiving 2.Discussion of concerns 3.Coping skill training 4.Problem solving 5.Expression of emotions 
Intervention  Relaxation Training  1.Simple Breathing exercise ( 2-3-5) cycle- 3 times / 5 minutes/day 2. Progressive Muscle Relaxation ( JPMR) Duration (20-30 minutes) 3days/Week 3. Pleasant nature imagery exercise with music Duration - 15-20 minutes Schedule - Morning ( Everyday) Total Duration : 3 months  
Comparator Agent  Usual Care available at the hospital  Medical and social intervention and general psychological intervention of regular practice 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Advance cancer patients ( Head and Neck / Lung)
2.Age should be 18 yrs and above
3. ECOG : 0-3
4. Physical symptoms severity (moderate - Severe)… ( pain, fatigue etc…) in NRS
5.HADS score greater than 11
6.Patient knows about diagnosis
7.Able to understand Hindi & English
 
 
ExclusionCriteria 
Details  1.Patient with any type of diagnosed psychiatric illness
2. GC is very poor
3.Not willing to participate in the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
• QOL
• Symptoms Severity
 
• At three months ( 12 weeks)

 
 
Secondary Outcome  
Outcome  TimePoints 
• Psychological Distress
• Changes in Decision Making
 
At 3 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   25/10/2021 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Cancer represents one of the leading causes of mortality and morbidity worldwide. Common physical symptoms that can interfere with daily functioning and quality of life include Pain, fatigue, breathlessness and sleep disturbance among advance cancer patients. From Psychological view point the term ‘Cancer’ is perceived as ‘Death’, ‘Suffering’ for many, often eliciting anxiety, existential crisis, distress and anticipatory grief. This is more prominent when the treatment intend is not cure only palliation.

Type of Research:   

·         Randomized Control Trial

·         Open label Study

·         Two Groups- Project EMPATHY vs.   Usual care (Intervention Arm vs.  Control Arm)

Objective:

ü  To test  the feasibility and acceptability of project  -EMPATHY for  reducing the bio-psycho-social distress of advance cancer patients

ü  To explore moderators and mediators of intervention effects

Hypothesis:

·         Participants who received Project ‘EMPATHY’ interventions would report less distress and QOL would be better compare to usual treatment                   

 A   Assessments:

·         Demographic History

Ø  Personal History :  Age , Gender, Domicile,  Marital Status ,Education , Employment Status ( Both Present & Past ), Family history of Cancer,

Ø  Medical History : Diagnosis , Stage, Treatment History,

Ø  Caregiver:  Primary caregiver , Gender , Age , marital Status, Education, Employment

·         Psychological Distress  ( HADS)

·         Quality of Life : QLQ 

·         

·          Symptoms severity - ESAS

·         Coping  :  Brief Cope

·         Treatment Decision making – One open ended question( Qualitative part) - for both pt. & care givers

·         Pt’s & caregiver’s Expectation related to treatment -One open ended question( Qualitative part)

-          Treatment outcome expectancy

EMPATHY

E    E= Educate

M= Monitor Symptoms Severity

P= Prognostic Discussion

A= Assurance

T = Training

H= Help to resolve problem

Y= You mean a lot to me


 
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