| CTRI Number |
CTRI/2024/07/071030 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
17/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Survey to assess the knowledge and practice of birth control methods among females with Breast cancer |
|
Scientific Title of Study
|
Awareness, attitude and practice of contraception among females with Breast cancer: A Hospital based survey |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shailley |
| Designation |
Associate Professor |
| Affiliation |
Pt B D Sharma Postgraduate Institute of Medical Sciences |
| Address |
Regional Cancer center
Department of Radiation Oncology,Pt B D Sharma PGIMS,Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8708536926 |
| Fax |
|
| Email |
pranjal.shailley@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailley |
| Designation |
Associate Professor |
| Affiliation |
Pt B D Sharma Postgraduate Institute of Medical Sciences |
| Address |
Regional Cancer center
Department of Radiation Oncology,Pt B D Sharma PGIMS,Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8708536926 |
| Fax |
|
| Email |
pranjal.shailley@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailley |
| Designation |
Associate Professor |
| Affiliation |
Pt B D Sharma Postgraduate Institute of Medical Sciences |
| Address |
Regional Cancer center
Department of Radiation Oncology,Pt B D Sharma PGIMS,Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8708536926 |
| Fax |
|
| Email |
pranjal.shailley@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt B D Sharma PGIMS,Rohtak -124001,Haryana, India |
|
|
Primary Sponsor
|
| Name |
Pt B D Sharma PGIMSRohtak |
| Address |
Regional cancer center,Department of Radiation Oncology,Pt B D Sharma PGIMS,Rohtak 124001
India |
| Type of Sponsor |
Government medical college |
|
|
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 Shailley |
Pt B D Sharma Postgraduate Institute of Medical Sciences |
Regional Cancer Center,
Department of Radiation Oncology,Pt B D Sharma PGIMS,Rohtak
Rohtak
HARYANA |
8708536926
pranjal.shailley@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Carcinoma Breast patients living with husband/sexual partner
Eastern Cooperative Oncology Group Performance status less than 2
Willing for informed consent |
|
| ExclusionCriteria |
| Details |
Menstrual irregularities/Menopausal
History of Hysterectomy
Eastern Cooperative Oncology Group PS ≥ 2 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Knowledge about awareness, attitude and current practice of contraception in carcinoma breast patients |
at Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Contraceptive counselling assessment |
After questionnaire completion of sample size or 6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
29/07/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Breast cancer is the most frequent cancer among females worldwide as per Globocan 2022. Approx. 645000 premenopausal breast cancer cases were diagnosed worldwide in 2018 which constitute 30.9% of total breast cancer cases.With increasing incidence and survival rates survivorship issues including motherhood and contraception, are increasingly being encountered in routine practice.Several studies that suggest increased rates of therapeutic abortion in any cancer survivor/patient in reproductive age group.Unintended pregnancy risk need to be shorten and ensure that they are planned when they are truly willing and in better health to bear pregnancy. Many a times less time is allotted to discuss regarding issues related to pregnancy and contraception. After diagnosis of cancer, psychological issues and other factors, female doesn’t want pregnancy. In a study based in France on 517 Breast cancer patients 15% pregnancies were unplanned and they found that these patients were less likely to have received fertility counseling (p=0.02) and contraceptive counseling (p=0.08) at the time of diagnosis. Multiple studies done internationally are suggestive of suboptimal counselling related to contraception.Thus there is high demand of effective and safe contraceptive method as well as counselling.There are multiple methods in use by general population with their advantages and disadvantages and also marked differences in efficacy during typical use. But there are limited guidelines by family planning societies on contraceptive use in cancer survivors and also they are not cancer specific. Which method is safest and easy to be used in this group is a big question/dilemma.Hormonal contraception is not indicated in such patients due to risk of thromboembolism and as it is itself predicted as risk factor for carcinoma breast. Behavioral and barrier methods have low efficacy. Depot medroxyprogesterone acetate is not recommended for patients with osteoporosis. In these women, the copper intrauterine device (IUD) seems to be a good choice. Schwarz et al also recommended the Copper T380A intrauterine device (IUD) as a highly effective, reversible, long-acting, hormone-free method for cancer survivors In India permanent method of contraception especially female sterilization is widely employed method with statistics suggesting that 37% of women in India aged between 15 and 49 are sterilized. But sterilization rate in breast cancer patients is not known in India. To the best of our knowledge no Indian data is available regarding contraceptive counseling as well as usage. Thus, we conducted this cross-sectional study in regional cancer center to know the awareness, attitude and most commonly utilized method. Contraceptive counseling present status will be assessed. If we know about the particular Patients’ need family planning methods/contraceptive counseling can be promoted accordingly. Contraceptive clinic reference can be done in timely manner and risk of unwanted pregnancies can be prevented.The aim is to assess the knowledge and attitude towards contraception and current utilization practices so as to fill up the lacunae in current contraceptive counselling. |