Assessment of cancer awareness

Not yet recruiting

• Conditions: For Arm 1 and Arm 2 – all alive women who were participants of earlier trial. For Arm 3 – similar age matched general female population residing in the nearby selected slums

• Registration Number: CTRI/2018/06/014554
• Lead Sponsor: Tata Memorial Hospital

Brief Summary

Cancers ofcervix and breast account for 50% of cancers and 42% of all deaths respectivelyfrom cancers among women in India. A research project entitled "EarlyDetection of Common Cancers in Women in India" was set up in 1998 by theTata Memorial Hospital to investigate the efficacy of simple low cost testssuch as Visual Inspection of the cervix with Acetic Acid (VIA) for the earlydetection of cervical cancers and Clinical Breast Examination (CBE) for theearly detection of breast cancers. In this project around 75,000 women wereenrolled in the Screening Arm. These women were invited for health education oncancer awareness and screening for breast and cervical cancers four times at aninterval of two years. The last time they received health education was arounda decade back. Another group of approximately 76,000 women were enrolled in theControl Arm of the trial. These women were invited for one single round ofcancer related health education at the time of enrollment, which was nearly 15years ago. The current sub-study is planned according to the instructions fromthe present External Data Safety Monitoring Committee (DSMC) after their reviewof the study in March 2016 and March 2017. It was advised by the DSMC toconduct a companion nested case control study to the main trial to evaluate thelong-term retention of the given cancer awareness education.

The PrimaryObjectives of the trial are to evaluate the long term retention of cancerawareness education among the trial participants.

**Methodology:Study Area:** Twentyslum-clusters of Mumbai, which were already selected by simple random samplingand randomized into 10 Screening-Clusters and 10 Control-Clusters, from theongoing study and one nearby slum cluster with similar socio – economicbackground, which was not included in the prior intervention.

**StudyPopulation:**

1) Arm 1:Randomly selected participants from one of the randomly selected clusters ofthe screening arm, from among the 10 screening clusters of the ongoing study

2) Arm 2:Randomly selected participants from one of the randomly selected clusters ofthe control arm, from among the 10 control clusters of the ongoing study

3) Arm 3:Socio-economically and age wise similar women from one new cluster which israndomly selected from the three slum clusters in Mumbai (wherein women havenot been exposed to such cancer awareness programme before).

The women willbe enrolled in the study only after obtaining the informed consent . Personalinterviews using a pre-designed questionnaire will be conducted for each ofthese enrolled women to evaluate the retention of health education amongparticipants in Arm 1 and Arm 2. The women from Arm 3 will also be interviewedusing the same questionnaire to assess their knowledge regarding variousaspects of cancer. The questionnaire will mainly cover the risk factors, signsand symptoms, methods of early detection, prevention and basic modality ofmanagement of breast, cervical and oral cavity cancers, since these topics werecovered in the health education delivered in the main study.

Sample size:Around 400 randomly selected participants from each arm will be listed.

Benefits:

a) Theinformation gained by conducting personal interviews will help us understandthe duration and content retention of health education about common cancers inwomen when delivered once and when delivered up to four times, as compared tothe similar general population of women who have never been exposed tostructured, organized cancer related health education. b) The results of thisstudy would be beneficial to guide the public health professionals and policymakers to understand better the modality, frequency and impact of communitybased health education.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2018-06-14
• Study Start: 2018-06-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 1200

Inclusion Criteria

• For Arm 1 and Arm 2 – all alive women who were participants of the selected cluster of the Intervention Arm and from the Control Arm respectively, of the earlier cluster randomized trial.
• For Arm 3 – similar age matched general female population residing in the nearby selected slum cluster and belonging to similar socio-economically disadvantaged population of Mumbai.

Exclusion Criteria

• Arm 1 & Arm 2: All women who were not a part of the earlier trial will be excluded.
• Arm 3: All women who are included in Arm 1 and Arm 2 will be excluded.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The long term retention of cancer awareness education among the trial participants will be assessed.	12 months

Secondary Outcome Measures

Name	Time	Method
b) We will investigate the prevalence of cancer awareness in socio-economically and age – wise similar general female population, who are not a part of the trial.
a) We will evaluate the long-term retention of cancer awareness education among the trial participants enrolled in the screening arm (received cancer awareness education up to four times) as compared to participants enrolled in the control arm (received cancer awareness education only once).	12 months

Trial Locations

Locations (1)

Tata Memorial Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Tata Memorial Hospital

🇮🇳Mumbai, MAHARASHTRA, India

Dr R A Badwe

Principal investigator

22-24177000

badwera@tmc.gov.in