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

Sponsor
Tata Memorial Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01271673
Collaborator
(none)
100
Enrollment
1
Location
5
Duration (Months)
20.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Study Start Date :
    Nov 1, 2010
    Anticipated Primary Completion Date :
    Feb 1, 2011
    Anticipated Study Completion Date :
    Apr 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Compliance to Breast Self Examination [3 months]

      To assess the level of compliance in undertaking Breast Self Examination among women attending Preventive Oncology Clinic.

    Secondary Outcome Measures

    1. Association of various socio-demographic factors and the level of compliance to Breast Self Examination [3 months]

      To study the association of various socio-demographic factors and level of compliance with Breast Self Examination.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    Female
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Preventive Oncology, Tata Memorial Hospital Mumbai Maharashtra India 400012

    Sponsors and Collaborators

    • Tata Memorial Hospital

    Investigators

    • Principal Investigator: Ketaki G Karnik, MSc, University of Pune
    • Principal Investigator: Gauravi A Mishra, MD, Tata Memorial Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01271673
    Other Study ID Numbers:
    • 827
    First Posted:
    Jan 7, 2011
    Last Update Posted:
    Jan 7, 2011
    Last Verified:
    Nov 1, 2010

    Study Results

    No Results Posted as of Jan 7, 2011