| CTRI Number |
CTRI/2024/07/070373 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
10/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to find out impact of health symptoms on health -related quality of life of patients with breast cancer undergoing chemotherapy with a view to develop an e-pamphlet for symptoms alleviation and its effectiveness in a selected tertiary hospital in India. |
|
Scientific Title of Study
|
Impact of health symptoms on health -related quality of life of patients with breast cancer undergoing chemotherapy with a view to develop an e-pamphlet for symptoms alleviation, in a selected tertiary hospital in India. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sriparna Giri |
| Designation |
Assistant Nursing Superintendent Cum Assistant Professor |
| Affiliation |
Tata Medical Center |
| Address |
Tata Medical Center
Newtown
Kolkata , WestBengal,700160
Daycare Phase -1,ROOM NO:HL1 01
Phone no:03366057109
Tata Medical Center
Newtown
Kolkata, West Bengal 700160
Kolkata
WEST BENGAL
700160
India |
| Phone |
9051297990 |
| Fax |
|
| Email |
sriparna24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sriparna Giri |
| Designation |
Assistant Nursing Superintendent Cum Assistant Professor |
| Affiliation |
Tata Medical Center |
| Address |
Tata Medical Center
Newtown
Kolkata 700160
Daycare Phase -1,ROOM NO:HL1 01
Phone no:03366057109
Tata Medical Center
Newtown
Kolkata , West Bengal700160
Kolkata
WEST BENGAL
700160
India |
| Phone |
9051297990 |
| Fax |
|
| Email |
sriparna24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sriparna Giri |
| Designation |
Assistant Nursing Superintendent Cum Assistant Professor |
| Affiliation |
Tata Medical Center |
| Address |
Tata Medical Center
Newtown
Kolkata 700160
Daycare Phase -1,ROOM NO:HL1 01
Phone no:03366057109
Tata Medical Center
Newtown
Kolkata West Bengal 700160
Kolkata
WEST BENGAL
700160
India |
| Phone |
9051297990 |
| Fax |
|
| Email |
sriparna24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Medical Center, New Town, Kolkata, WestBengal, 700160
e-pamphlet development will be by the Principal Investigator |
|
|
Primary Sponsor
|
| Name |
Sriparna Giri |
| Address |
Tata Medical Center, Newtown, Kolkata, West Bengal, 700160 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sriparna Giri |
Tata Medical Center |
Daycare, Chemotherapy department .General medical ward and Private ward.
Kolkata
WEST BENGAL |
9051297990
sriparna24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Medical Center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50-C50||Malignant neoplasms of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
booklet on "managing Chemotherapy side effect" |
standard of care that is booklet on "managing Chemotherapy side effect" will be given on 1st cycle |
| Intervention |
e-pamphlet named "Flourish Femina" |
which is a teaching module which will contain about breast cancer, chemotherapy and how to manage side effects of chemotherapy , nutrition, infection prevention and life style modification details in writing and few videos and standard of care that is booklet on "managing Chemotherapy side effect" will be given on 1st cycle |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
Patients receiving chemotherapy regimens and willing to participate
Patients without evidence of psychosis, dementia and able to complete
Not suffering as a secondary cancer |
|
| ExclusionCriteria |
| Details |
Women who are unwilling or unable to consent and unable to complete the
questionnaire and unable to use smart phone.
ï‚· Patient who does not follow instructions and cannot speak in English,
Bengali or Hindi.
ï‚· Severely ill, foreign patients, or those not completing treatment at Tata
Medical Center |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Symptoms alleviation and improve quality of life of Ca breast patient receiving chemotherapy which will be measure by EORTC c-30 and EORTC BR 45 |
finishing 7cycle of chemotherapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| quality of life of patient will improve |
Health Symptoms & Quality of life will be checked base line before starting of chemotherapy, cycle 4 & cycle 8 |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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)
|
25/07/2024 |
| 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="6"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The ultimate aim of the study is to explore the impact of symptoms on quality of life of patients with breast cancer undergoing chemotherapy and develop a e-pamphlet and to find out its effect on symptoms alleviation and quality of life. Structured Interview Schedule on demographic variables, EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Standardized tool on Quality of life of Cancer patient) and EORTC QLQ BR 45 (Breast Cancer module is a supplementary questionnaire with QLQ-30) will be used to assess quality of patient receiving chemotherapy. It will be randomized control trial. Total sample size 126. In phase I, 12 sample will be taken to find out symptoms and based on result e-pamphlet will be develop. Control arm will receive normal health education and a booklet on “Managing Chemotherapy side effects†and experimental group will receive both health education, booklet and e-pamphlet on 1st cycle of chemotherapy. But experimental group will be reinforced to check e-pamphlet on 2nd and 5th cycle of chemotherapy. Base line data will be collected on 1st cycle and then 4th and last data will be collected after 7th cycle. So by this study we will be able to find out 1. Symptoms experienced by breast cancer patient during chemotherapy, 2. Effect of symptoms on quality of life (QoL), 3. E-pamphlet will have any effect on health symptoms and QoL or not and 4. there is any association between selected demographic criteria and symptoms and QoL. |