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

Breast Self Examination Clinical Trial

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01271673
• Other study ID #: 827
• Status: Unknown status
• Phase: N/A
• First received: January 6, 2011
• Last updated: January 6, 2011
• Start date: November 2010
• Est. completion date: April 2011

Study information

• Verified date: November 2010
• Source: Tata Memorial Hospital
• Contact: Ketaki G Karnik, MSc
• Phone: +91-9920493177
• Email: ketakikarnik88[@]gmial.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 100
• Est. completion date: April 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Self Examination

Locations

Country	Name	City	State
India	Department of Preventive Oncology, Tata Memorial Hospital	Mumbai	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Tata Memorial Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance to Breast Self Examination	To assess the level of compliance in undertaking Breast Self Examination among women attending Preventive Oncology Clinic.	3 months
Secondary	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.	3 months