| CTRI Number |
CTRI/2019/06/019663 [Registered on: 14/06/2019] Trial Registered Prospectively |
| Last Modified On: |
13/06/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Quality of life and the factors determining the quality of life of long term breast cancer survivors |
|
Scientific Title of Study
|
Quality of life and its determinants among long term survivors of Breast Cancer |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Binsha Pappachan C |
| Designation |
Associate Professor |
| Affiliation |
Father Muller College of Nursing |
| Address |
Father Muller College of Nursing, Mangalore
Father Muller College of Nursing, Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9964340783 |
| Fax |
|
| Email |
binshadennis@fathermuller.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Binsha Pappachan C |
| Designation |
Associate Professor |
| Affiliation |
Father Muller Medical College Hospital |
| Address |
Father Muller College of Nursing, Mangalore
Father Muller Charitable Institutions, Mangalore Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9964340783 |
| Fax |
|
| Email |
binshadennis@fathermuller.in |
|
Details of Contact Person
Public Query
|
| Name |
Binsha Pappachan C |
| Designation |
Associate Professor |
| Affiliation |
Father Muller Medical College Hospital |
| Address |
Father Muller College of Nursing, Mangalore
Father Muller College of Nursing, Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9964340783 |
| Fax |
|
| Email |
binshadennis@fathermuller.in |
|
|
Source of Monetary or Material Support
|
| Father Muller Research Centre, Father Muller Medical College Hospital, Kankanady, Mangalore |
|
|
Primary Sponsor
|
| Name |
Father Muller Research Centre |
| Address |
Father Muller Charitable Institutions, Kankanady, Mangalore |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Mrs Binsha Pappachan C |
Father Muller Medical College Hospital |
Out Patient Department and wards of Father Muller Oncology Department
Dakshina Kannada
KARNATAKA |
9964340783
binshadennis@fathermuller.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1 Breast cancer survivors aged between 20-70 years
2. Women who can read, write and speak English or Kannada
|
|
| ExclusionCriteria |
| Details |
1. Breast cancer survivors who had a relapse
2. Breast cancer survivors who are not willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Quality of Life
|
Follow up visit after one year of active treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Determinants of Quality of Life |
Follow up visit after one year of active treatment |
|
|
Target Sample Size
|
Total Sample Size="267"
Sample Size from India="267"
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 1 |
|
Date of First Enrollment (India)
|
01/08/2019 |
| 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
|
not yet started |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is selected with an aim of understanding the level of Quality of Life and the factors that decides the level of Quality of life among women living as survivors of breast cancer. The hypothesis is there will be a significant association of quality of life with selected demographic variables |