| 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
|
|
|
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
|
|
|
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
|