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Cohort Study to Assess the Level of Compliance in Undertaking Breast Self Examination Among Women Attending Preventive Oncology Clinic

A Short Duration Pilot Cohort Study to Assess the Level of Compliance in Undertaking Breast Self Examination (BSE) Among Women Attending Preventive Oncology Clinic

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01271673
Enrollment
100
Registered
2011-01-07
Start date
2010-11-30
Completion date
2011-04-30
Last updated
2011-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Self Examination

Brief 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. 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.

Interventions

None listed

Sponsors

Tata Memorial Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Women attending Preventive Oncology Clinic during the month of November-December 2010. * Women undertaking BSE training. * Residential address mentioned as Mumbai. * Contact number available.

Exclusion criteria

* Women residing outside Mumbai, Maharashtra.

Design outcomes

Primary

MeasureTime frameDescription
Compliance to Breast Self Examination3 monthsTo assess the level of compliance in undertaking Breast Self Examination among women attending Preventive Oncology Clinic.

Secondary

MeasureTime frameDescription
Association of various socio-demographic factors and the level of compliance to Breast Self Examination3 monthsTo study the association of various socio-demographic factors and level of compliance with Breast Self Examination.

Countries

India

Contacts

Primary ContactKetaki G Karnik, MSc
ketakikarnik88@gmial.com+91-9920493177
Backup ContactGauravi A Mishra, MD
gauravi2005@yahoo.co.in+91-22-24157532

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026