| CTRI Number |
CTRI/2017/06/008858 [Registered on: 19/06/2017] Trial Registered Retrospectively |
| Last Modified On: |
21/08/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Qualitative |
| Study Design |
Other |
|
Public Title of Study
|
A study on experiences and requirements of breast cancer patients who have completed chemotherapy,radiotherapy or surgery in South Canara region of Karnataka |
|
Scientific Title of Study
|
A qualitative study on experiences and needs of breast cancer survivors in South Canara region of Karnataka |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sushma Marita Dsouza |
| Designation |
2nd Year Master of Public Health Student |
| Affiliation |
Manipal University |
| Address |
Department of Public Health,
Manipal University,
Manipal.
Manipal University,
Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9008897827 |
| Fax |
9008897827 |
| Email |
sushmadsouza22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navya Vyas |
| Designation |
Assistant professor |
| Affiliation |
Manipal University |
| Address |
Department of Public Health, Manipal University,
Manipal.
Manipal University,
Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9538126121 |
| Fax |
|
| Email |
navya.vyas@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sushma Marita Dsouza |
| Designation |
2nd Year Master of Public Health Student |
| Affiliation |
Manipal University |
| Address |
Department of Public Health,
Manipal University,
Manipal.
Manipal University,
Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9008897827 |
| Fax |
|
| Email |
sushmadsouza22@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sushma Marita Dsouza |
| Address |
DOOR NO: 3-119
MARCEL DSOUZA
BORGALGUDEDE HOUSE
MANIPURA POST
UDUPI - 576120 |
| Type of Sponsor |
Other [Private sponser] |
|
|
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 |
| DR KRISHNA SHARAN |
Shirdi Sai Baba Cancer Hospital and Research center |
Kasturba Medical College,
Manipal, Udupi -576104
Udupi
KARNATAKA |
9448625116
tk.sharan@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KASTURBA HOSPITAL,MANIPAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Breast cancer survivors those who have completed chemotherapy, radiotherapy or surgery, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
Those who are willing to participate.
Women with breast cancer who have completed chemotherapy, radiation therapy or surgery. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Experiences and Needs of breast cancer survivors can be explored. |
January 2017 to June 2017 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
22/01/2017 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Globally the incidence of breast cancer is high among women aged above 50 years whereas in India the incidence is high among women aged above 40 years. In India Breast cancer is diagnosed most commonly after cervical cancer. The incidence rate of breast cancer varies from 9 to 32 per 1, 00,000 women which is age standardized in India. Moreover largest estimated numbers of breast cancer deaths occur in India.The breast cancer patients suffer from physical, emotional, psychological, financial and social disturbances at a large extent and it is found that unmet needs were high in the post-treatment phase among cancer patients than any other phase of cancer continuum. Health care practitioners should address needs of breast cancer survivors in order to support them to return to the normal way of life.Understanding the needs of cancer survivors makes the health care patient-centered.In low and middle income countries the breast cancer.Many cancer survivors will have unmet supportive care needs beyond the successful treatment where the care shifts to community settings, where the community plays an important role in meeting the needs of cancer survivors along with health care facilities. In order to enhance the quality of life it is necessary to understand needs and experiences of the breast cancer patients. The existing knowledge on needs and experiences of the breast cancer survivors is very limited. Few studies have been conducted in India with regard to needs and experiences of breast cancer survivors. Hence this study is intended to explore the experiences and needs of breast cancer survivors. |