| CTRI Number |
CTRI/2024/11/076490 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
08/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Interventional package on modifiable risk factors of breast cancer |
|
Scientific Title of Study
|
Effectiveness of Interventional package on modifiable risk factors of breast cancer among high risk women-Randomized control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Catherine K |
| Designation |
Assistant Professor / Research Scholar |
| Affiliation |
College of Nursing Pondicherry Institute of Medical Sciences |
| Address |
Catherine K
Assistant Professor
Department of Obstetrics and Gynecological Nursing
College of Nursing
Pondicherry Institute of Medical Sciences
Ganapathichettikulam
Puducherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
7868023531 |
| Fax |
|
| Email |
derickyadhon@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Catherine K |
| Designation |
Assistant Professor / Research Scholar |
| Affiliation |
College of Nursing Pondicherry Institute of Medical Sciences |
| Address |
Catherine K
Assistant Professor
Department of Obstetrics and Gynecological Nursing
College of Nursing
Pondicherry Institute of Medical Sciences
Ganapathichettikulam
Puducherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
7868023531 |
| Fax |
|
| Email |
derickyadhon@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Catherine K |
| Designation |
Assistant Professor / Research Scholar |
| Affiliation |
College of Nursing Pondicherry Institute of Medical Sciences |
| Address |
Catherine K
Assistant Professor
Department of Obstetrics and Gynecological Nursing
College of Nursing
Pondicherry Institute of Medical Sciences
Ganapathichettikulam
Puducherry
India
Pondicherry
PONDICHERRY
605014
India |
| Phone |
7868023531 |
| Fax |
|
| Email |
derickyadhon@gmail.com |
|
|
Source of Monetary or Material Support
|
| Health and wellness center Ariyankuppam and Thavalakuppam
Church street
Near church
Ariyankuppam
Puducherry
Pincode 605007
India
|
|
|
Primary Sponsor
|
| Name |
Catherine K |
| Address |
Catherine K
Assistant Professor
Department of Obstetrics and Gynecological Nursing
College of Nursing
Pondicherry Institute of Medical Sciences
Ganapathichettikulam
Puducherry
Pincode 605014
India |
| Type of Sponsor |
Other [Self ] |
|
|
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 |
| DrShyamala |
Ariyankuppam and Thavalakuppam PHC and its community areas |
Ariyankuppam Primary Health Centre
Church street
Near Church
Ariyankuppam
Puducherry
Puducherry
Pondicherry
PONDICHERRY |
9790646300
yadhonsavin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIMS INSTITUTE ETHICS COMMITTEE (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Preventive and screening interventions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Interventional package on Modifiable risk factors of breast cancer |
1. Information Education Communication IEC on breast cancer - Teaching sessions (PPT) and training sessions on practice of breast self examination using breast model
2. Nutritional education by flash cards
3. Phytoestrogen diet-soya administration 5 grams daily for 5 days in a week
4. Exercise-moderate intensity brisk walking for 60minutes per session -3 days in a week
5. Mindfulness therapy- 3 days in a week for about 20 minutes per session
Total duration of intervention is 9 months |
| Intervention |
routine practice |
women in control group will follow routine practice
They will be followed for a period of 9 months |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
High risk for breast cancer according to Snehita Breast cancer risk calculator tool
Age group of 30-45 years
Regular menstrual cycle
Obese and Overweight as per WHO BMI |
|
| ExclusionCriteria |
| Details |
Women with personal history of any cancer at present or treated earlier
History of allergy to soya beans
Hypothyroidism ( Soya can interfere with absorption of thyroid medication )
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| changes in the modifiable risk factors of breast cancer ( level of lifestyle practices, 24 hours dietary pattern and clinical parameters) among high risk women |
At baseline
end of 3rd month
end of 6th month
end of 9th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in the level of awareness among high risk women
correlation between level of awareness & level of lifestyle practice |
At baseline
at 21st day after teaching session
at the end of 3rd month
end of 6th month
end of 9th month
|
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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)
|
02/12/2024 |
| 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="0"
Months="10"
Days="0" |
|
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [derickyadhon@gmail.com].
- For how long will this data be available start date provided 02-12-2024 and end date provided 02-12-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
After obtaining formal permission from medical officer in the concerned rural area, women between 30-45 years will be screened for high risk category by Snehita brisk model (online calculator).women fulfilling the inclusion criteria will be selected and informed consent will be obtained. women in the control group will follow routine practice and experimental group will be given package of interventions for 9 months. Pre-test on level of awareness, level of lifestyle practices, 24 hours dietary recall and Clinical parameters ( SBP, DBP, height, weight, BMI, Body composition- body fat, visceral fat, skeletal muscle, WhtR, Fasting Blood glucose and serum Estradiol will be done for both the groups.
The interventions include 1. Information Education Communication IEC on Breast cancer by teaching sessions (PPT) and training sessions on practice of Breast self examination (Breast model) 2. Nutritional Education using flash cards 3. Phytoestrogen diet -Soya beans 5 grams daily - 5 days per week . It will be provided by the researcher. It has to be soaked previous day night and has to be consumed next day morning after breakfast 4.Exercise - Moderate intensity brisk walking for 3 days in a week for about 60 minutes per session starting and ending with warm up exercises 5. Mindfulness therapy - must practice 3 days in a week for about 20 minutes as taught by the researcher
Post test will be done at the end of 3rd month, 6th month and 9th month Post test on Serum estradiol alone will be done at the end of the study
|