- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02108314
Video-assisted Intervention for Increasing Mammography Uptake in Private Primary Care in Singapore
Physician-led Video-assisted Intervention for Increasing Mammography Uptake in Private Primary Care Practice in Singapore: A Cluster-Randomized Trial
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Breast cancer is the second leading cause of cancer-related deaths in women with an estimate of 508 000 deaths in 2011 worldwide . Incidence rates vary from 19.3 per 100,000 women in Eastern Africa to 89.7 per 100,000 women in Western Europe . Locally, 1 in every 16 Singaporean women in their lifetime is affected, making it the most common cancer in women in Singapore, with 17.9% of cancer deaths in women attributed to it. The Singapore Cancer Registry (2012) also revealed that the age-standardised incidence rates of newly diagnosed breast cancer have increased from 22.0 per 100,000 in the 1973-1977 period to 62.4 per 100,000 in the 2008-2012 period .
Studies have consistently shown that mammography is effective in early detection of breast cancer - , reducing breast cancer mortality of 20-22% . However, recent studies have questioned the efficacy of mammography. Gotszche et al. challenged that past trials had inadequate randomization , while a 1998 Cochrane Review questioned the potential confounding effect of advances in adjuvant chemotherapy (i.e. Tamoxifen) on overall breast cancer survival rates . With reference to the 2005 New England Journal of Medicine paper by Berry et al, screening remains an effective tool, and with therapy, has contributed to the decline in related mortality. In a 2011 local paper, Wang et al compared screen-detected and symptomatic women, concluding that screen-detected patients had an overall higher survival rates that their symptomatic counterparts .
For the past 15 years, the nationwide breast cancer-screening programme in Singapore has been recommending women aged 40-69 to undergo screening mammography, emphasizing that women in the younger age group of 40-49 should be screened once a year due to the unique local age-specific incidence rates showing an unusually high incidence of 34.4% in women aged 45-54 . Despite aggressive efforts and incentives, mammography uptake rates poor. A National Health Survey in 2010 revealed that 3 in 5 women are not going for their regular mammography at recommended frequencies . A pre-pilot study by Seow et al in 2009 showed that up to 27.4% of women surveyed had never had a mammogram before. A recent paper published in 2013 by Teo et al. also reported that regular mammography uptake rates are at a dismal rate of 26% . Dismal uptake rates are notably equally rampant in other countries, with a varying 40% to 90% of women quoted to be non-compliant to their respective breast cancer screening programmes . Local studies have revealed fear of pain and a belief that cancer would not happen to them as some barriers to screening . Teo et al. also revealed predictors of poor uptake as that of low income group, poor educational level, fear of pain/discomfort as well as being Malay. This illustrates the multidimensional influence of race, ethnicity, knowledge and health-seeking behavior in determining the compliance to regular screening.
With previous studies identifying various barriers to Singapore's mammography-screening program, the investigators hope to go further by evaluating the effectiveness of targeted interventions in helping women overcome said barriers. While there have been multiple trials done overseas - to determine the effectiveness of various interventions, there has only been two such local trials by Seow et al in 2012 and 1998 done in a public sector primary care setting - . As 80% of primary care in Singapore occurs in the private sector, conducting the study there would represent a different demographic of patient characteristics that has wider applicability. Furthermore, the strong doctor-patient relationship may help with the effectiveness of General Practitioner (GP)-based intervention. A key factor may therefore be lack of physician recommendation . Published evidence suggests patients were more likely to follow up with mammography screening when their primary care practitioner ordered testing - . As such, the investigators hope to design and evaluate a cost effective, feasible and relevant intervention that can be realistically implemented with the resources available in the workflow of the average GP clinic without additional resources and manpower requirements.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Singapore, Singapore
- Multiple General Practitioner Clinics in Singapore
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
All women aged 40 - 69 years old registering at the clinic will be screened. For inclusion into either the intervention or control procedures, participants must be:
- 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
Exclusion Criteria:
- 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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Undersökning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Inget ingripande: Control Group
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.
|
|
Aktiv komparator: Video Screening and Counselling
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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Mammography Uptake
Tidsram: 3 days after intervention
|
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
Tidsram: 120 days after intervention
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Stages of behavior change
Tidsram: 3 days after intervention
|
The investigators also measure if there is an intention to have a mammogram as indicated by making of an appointment, and intention to make an appointment based on self-reporting.
|
3 days after intervention
|
Stages of behavior change
Tidsram: 120 days after intervention
|
The investigators also measure if there is an intention to have a mammogram as indicated by making of an appointment, and intention to make an appointment based on self-reporting.
|
120 days after intervention
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Mark Chen, PhD, NUHS
- Studierektor: Fong Seng Lim, M.Med, NUHS
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 13-494
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Mammogram Schemalagt
-
University of North Carolina, Chapel HillIndragenJämförelse av stationär brösttomosyntes och 2-D digital mammografi hos patienter med bröstförstoringMammogram SchemalagtFörenta staterna
-
Micrima, Ltd.Avslutad
Kliniska prövningar på Video Screening and Counselling
-
Icahn School of Medicine at Mount SinaiNational Institute of Mental Health (NIMH)RekryteringFörsta episod psykos (FEP) | Klinisk högrisk för psykos (CHR)Förenta staterna
-
Northwell HealthNational Institute on Aging (NIA)Aktiv, inte rekryterande
-
Northwell HealthNational Institute on Aging (NIA)Aktiv, inte rekryterandeDeliriumFörenta staterna
-
NYU Langone HealthUnited States Department of DefenseAvslutad
-
Abramson Cancer Center at Penn MedicineGilead SciencesRekryteringBröstcancer | Sociala bestämningsfaktorer för hälsa (SDOH)Förenta staterna
-
Massachusetts General HospitalCenter for Survey Research, University of Massachusetts, BostonAvslutadKolorektal cancer | Högt kolesterolFörenta staterna
-
Vanderbilt UniversityAvslutad
-
Washington State UniversityNational Institute on Drug Abuse (NIDA)AvslutadSubstansmissbrukFörenta staterna
-
University of PennsylvaniaAmerican Heart AssociationAvslutadKranskärlssjukdom | Hjärtstopp | Kardiovaskulära riskfaktorerFörenta staterna
-
University of PennsylvaniaAvslutadKranskärlssjukdom | Hjärtstopp | Kardiovaskulära riskfaktorerFörenta staterna