Effectiveness of project EMPATHY on the improvement of Quality Of Life(QOL) in patients with advance cancer - A Randomized Control Trial

Cancer represents one of the leading causes ofmortality and morbidity worldwide. Common physical symptoms that can interferewith daily functioning and quality of life include Pain, fatigue,breathlessness and sleep disturbance among advance cancer patients. FromPsychological view point the term ‘Cancer’ is perceived as ‘Death’, ‘Suffering’for many, often eliciting anxiety, existential crisis, distress andanticipatory grief. This is more prominent when the treatment intend is notcure only palliation.

Typeof Research:

·        Randomized Control Trial

·        Open label Study

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

Objective:

ü  Totest  the feasibility and acceptabilityof project  -EMPATHY for  reducing the bio-psycho-social distress ofadvance cancer patients

ü  Toexplore moderators and mediators of intervention effects

Hypothesis:

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

A   Assessments:

·        Demographic History

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

Ø  MedicalHistory : Diagnosis , Stage, Treatment History,

Ø  Caregiver:  Primary caregiver , Gender , Age , maritalStatus, Education, Employment

·        Psychological Distress  ( HADS)

·        Quality of Life : QLQ

·

·         Symptoms severity - ESAS

·        Coping :  Brief Cope

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

·        Pt’s & caregiver’s Expectationrelated 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