Breast Self ExaminationNCT01271673
Cohort Study to Assess the Level of Compliance in Undertaking Breast Self Examination Among Women Attending Preventive Oncology Clinic
An observational study of Breast Self Examination, run by Tata Memorial Hospital at 1 site in India.
Trial summary
Breast cancer is the most common cancer among women residing in majority of the urban areas in India. The deaths due to breast cancer are mainly a result of late presentation of the symptoms due to lack of awareness of the signs and symptoms of the disease and lack of knowledge of performing BSE. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Self Examination
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2010to Apr 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women attending Preventive Oncology Clinic in the month of November-December 2010.
Who may be able to join
- Women attending Preventive Oncology Clinic during the month of November-December 2010.
- Women undertaking BSE training.
- Residential address mentioned as Mumbai.
- Contact number available.
Who cannot join
- Women residing outside Mumbai, Maharashtra.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Department of Preventive Oncology, Tata Memorial Hospital
Mumbai, Maharashtra, 400012
Ketaki G Karnik, MSc Health Sciences, +91-9920493177, ketakikarnik88@gmail.com
Gauravi A Mishra, MD, +91-22-24157532, gauravi2005@yahoo.co.in
About this study
Official title: A Short Duration Pilot Cohort Study to Assess the Level of Compliance in Undertaking Breast Self Examination (BSE) Among Women Attending Preventive Oncology Clinic
Breast cancer is the most common cancer among women residing in majority of the urban areas in India. The deaths due to breast cancer are mainly a result of late presentation of the symptoms due to lack of awareness of the signs and symptoms of the disease and lack of knowledge of performing BSE. The BSE technique can be a good tool for improving the awareness about the symptoms of breast cancer. Hence, we propose a pilot study of short duration (3 months follow-up), to assess the level of compliance to BSE and assess the various reasons for non-compliance. Based on the results of this study a long term cohort study will be planned with similar objectives.
Read the detailed description
This is an observational cohort study about BSE among women attending the Preventive Oncology (PO) Clinic, TMH. All women attending for screening of common cancers at the Preventive Oncology OPD at TMH are demonstrated the technique of BSE and advised on when, how and why to perform BSE.
Women attending the PO clinic and who have mentioned their residential address as Mumbai and provided contact number will be invited to participate in the study. They will be explained the study protocol and those who are interested in participating will be offered informed consent forms. The women who sign the informed consent form will be enrolled into the trial.
The data regarding the socio-demographic details and level of knowledge, attitude and practice (KAP) about breast cancer and BSE will be collected from the participating women. They will be asked if they have any doubts regarding the technique of BSE and their willingness to perform BSE. Thereafter, a follow-up period of 3 months, the women will be contacted telephonically to collect the data to assess the level of compliance to BSE and the reasons for non-compliance, if any. Also, the compliant women will be asked if they have observed any abnormal changes in their breasts and have they visited the clinician for the same. And subsequently, their health care seeking behaviour will be studied.
The data collected before and after the follow-up will be entered in the SPSS software and analyzed using simple statistical tests like mean, chi-square, t-test and univariate and multivariate analysis.
- Conditions
- Breast Self Examination
- Medical subject headings
- Breast Self-Examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women undertaking Breast Self Examination | Women attending Preventive Oncology Clinic during the month of November- December 2010,and undertaking BSE training whose Residential address mentioned as Mumbai and whose Contact number is available. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance to Breast Self Examination
To assess the level of compliance in undertaking Breast Self Examination among women attending Preventive Oncology Clinic.
Measured: 3 months
Secondary outcomes (1)
Association of various socio-demographic factors and the level of compliance to Breast Self Examination
To study the association of various socio-demographic factors and level of compliance with Breast Self Examination.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study startNov 2010
- Primary completionFeb 2011 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Self ExaminationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Investigators
- Ketaki G Karnik, MSc, Principal investigator, University of PuneGauravi A Mishra, MD, Principal investigator, Tata Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01271673
- Sponsor's protocol ID
- 827
- Status last verified
- Nov 2010
- First submitted
- 6 Jan 2011
- Last updated
- 7 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Short Duration Pilot Cohort Study to Assess the Level of Compliance in Undertaking Breast Self Examination (BSE) Among Women Attending Preventive Oncology Clinic
- ClinicalTrials.gov ID
- NCT01271673
- Acronym / sponsor ID
- 827
- Conditions
- Breast Self Examination
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tata Memorial HospitalOther government
- Study start
- Nov 2010
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 7 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast cancer is the most common cancer among women residing in majority of the urban areas in India. The deaths due to breast cancer are mainly a result of late presentation of the symptoms due to lack of awareness of the signs and symptoms of the disease and lack of knowledge of performing BSE. The BSE technique can be a good tool for improving the awareness about the symptoms of breast cancer. Hence, we propose a pilot study of short duration (3 months follow-up), to assess the level of compliance to BSE and assess the various reasons for non-compliance. Based on the results of this study a long term cohort study will be planned with similar objectives.
Detailed description
This is an observational cohort study about BSE among women attending the Preventive Oncology (PO) Clinic, TMH. All women attending for screening of common cancers at the Preventive Oncology OPD at TMH are demonstrated the technique of BSE and advised on when, how and why to perform BSE.
Women attending the PO clinic and who have mentioned their residential address as Mumbai and provided contact number will be invited to participate in the study. They will be explained the study protocol and those who are interested in participating will be offered informed consent forms. The women who sign the informed consent form will be enrolled into the trial.
The data regarding the socio-demographic details and level of knowledge, attitude and practice (KAP) about breast cancer and BSE will be collected from the participating women. They will be asked if they have any doubts regarding the technique of BSE and their willingness to perform BSE. Thereafter, a follow-up period of 3 months, the women will be contacted telephonically to collect the data to assess the level of compliance to BSE and the reasons for non-compliance, if any. Also, the compliant women will be asked if they have observed any abnormal changes in their breasts and have they visited the clinician for the same. And subsequently, their health care seeking behaviour will be studied.
The data collected before and after the follow-up will be entered in the SPSS software and analyzed using simple statistical tests like mean, chi-square, t-test and univariate and multivariate analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women undertaking Breast Self Examination | – | –Women attending Preventive Oncology Clinic during the month of November- December 2010,and undertaking BSE training whose Residential address mentioned as Mumbai and whose Contact number is available. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women attending Preventive Oncology Clinic in the month of November-December 2010.
Key inclusion criteria (4 listed)
- Women attending Preventive Oncology Clinic during the month of November-December 2010.
- Women undertaking BSE training.
- Residential address mentioned as Mumbai.
- Contact number available.
Key exclusion criteria (1 listed)
- Women residing outside Mumbai, Maharashtra.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compliance to Breast Self Examination
Time frame: 3 months
To assess the level of compliance in undertaking Breast Self Examination among women attending Preventive Oncology Clinic.
1 secondary outcome
Association of various socio-demographic factors and the level of compliance to Breast Self Examination
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ketaki G Karnik, MSc principal investigator
University of Pune
Gauravi A Mishra, MD principal investigator
Tata Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Self Examination, run by Tata Memorial Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ketaki G Karnik, MSc (+91-9920493177, ketakikarnik88@gmial.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance to Breast Self Examination (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2011.