NCT02108314

Brief Summary

Breast cancer is the leading female cancer in Singapore, but 3 in 5 women are not going for their regular mammography screenings at recommended frequencies despite 15 years of nationwide efforts by Breast Screen Singapore. The investigators aim to determine the efficacy of opportunistic health promotion for uptake of mammography screening in Singaporean women attending private sector primary care clinics in Singapore by implementing a simple and feasible questionnaire to identify potential candidates for mammography screening, coupled with recommendations by the primary care provider and a directed promotional video produced by Kandang Kerbau Hospital (KKH) that is aimed at addressing some of the barriers to screening.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
448

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 9, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

September 30, 2016

Status Verified

September 1, 2016

Enrollment Period

10 months

First QC Date

March 31, 2014

Last Update Submit

September 29, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • Mammography Uptake

    The primary outcome is assessing the effectiveness of specific interventions in promoting mammography uptake in Singaporean females who are non-compliant to regular mammography. This was measured via self-reporting of mammography at 3 and 120 days.

    3 days after intervention

  • Mammography Uptake

    The primary outcome is assessing the effectiveness of specific interventions in promoting mammography uptake in Singaporean females who are non-compliant to regular mammography. This was measured via self-reporting of mammography at 3 and 120 days.

    120 days after intervention

Secondary Outcomes (2)

  • Stages of behavior change

    3 days after intervention

  • Stages of behavior change

    120 days after intervention

Study Arms (2)

Control Group

NO INTERVENTION

Participants in the control arm were blinded as to the hypothesis of the study, undergoing a series of questions in about general health behaviours before their consultation, allowing the investigators to determine eligibility for the study. The associated participant information sheets for the control arm did not specifically mention breast cancer screening, maintaining blinding throughout. There was no reminder to the physician to promote mammography to participants. The physician continued with his or her usual counseling on health screening and mammography, if any. A 3-minute health promotion video by the Singapore Heart Foundation on healthy eating habits was administered to each participant, followed by a post-consultation questionnaire. The entire process took approximately 10 minutes.

Video Screening and Counselling

ACTIVE COMPARATOR

The intervention comprises 1) GP counseling, 2) 3-minute promotional video on mammography and 3) an informational brochure with relevant contact details and information for arranging a mammography screening. Pre- and post-consultation questionnaire were administered to participants to evaluate their health beliefs, with emphasis on breast cancer and mammography.

Behavioral: Video Screening and Counselling

Interventions

The intervention comprises 1) GP counseling, 2) 3-minute promotional video on mammography and 3) an informational brochure with relevant contact details and information for arranging a mammography screening. Pre- and post-consultation questionnaire were administered to participants to evaluate their health beliefs, with emphasis on breast cancer and mammography.

Video Screening and Counselling

Eligibility Criteria

Age40 Years - 69 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Singapore citizens or Permanent Residents
  • Women aged 40 - 69 years old who are not regularly undergoing mammography screening as per Singapore breast cancer screening guidelines, i.e.:
  • A) Not done a mammogram in the past 1 year if they are 40 to 49 years old B) Not done a mammogram in the past 2 years if they are 50 to 69 years old

You may not qualify if:

  • Women who have already enrolled in the study (i.e. at a previous visit to the same or even other GP).
  • Women who undergo regular mammography screenings (see above).
  • Women with a personal history of breast cancer.
  • Women who are unable to give informed consent (e.g. mentally incapacitated).
  • Women who have requested to be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Multiple General Practitioner Clinics in Singapore

Singapore, Singapore, Singapore

Location

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Mark Chen, PhD

    NUHS

    PRINCIPAL INVESTIGATOR
  • Fong Seng Lim, M.Med

    NUHS

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 31, 2014

First Posted

April 9, 2014

Study Start

February 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

September 30, 2016

Record last verified: 2016-09

Locations