Study Chinese Women Who Have Not Adhered to American Cancer Society Mammography Screening GuidelinePhase 3NCT01261520
Chinese Women and Mammography Screening
A Phase 3 study testing Culturally-tailored video in people with Study Chinese Women Who Have Not Adhered to American Cancer Society Mammography Screening Guideline, run by Georgetown University at 1 site in United States.
Trial summary
This study examined whether a culturally-tailored video has a greater impact on increasing mammography use in Chinese American women and improving barriers to mammography screening compared to a generic, non-tailored video and a printed fact sheet (control group). Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Study Chinese Women Who Have Not Adhered to American Cancer Society Mammography Screening Guideline
- What is being tested?
- Culturally-tailored video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 671 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Aug 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chinese American women had not had a mammography in the past 12 months
- Chinese American women had no personal history of breast cancer
- Chinese American women had no mammogram scheduled when enrolled
Who cannot join
- Non-Chinese Women
- Regular mammography users
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Control Program, Georgetown University
Washington D.C., District of Columbia, 20007
About this study
Official title: Promoting Adherence to Mammography Use in Chinese Women
This study examined whether a culturally-tailored video has a greater impact on increasing mammography use in Chinese American women and improving barriers to mammography screening compared to a generic, non-tailored video and a printed fact sheet (control group).
Read the detailed description
This study examined the efficacy of a culturally-tailored video in increasing mammography use among non-adherent Chinese women (vs. a generic video and control fact sheet). A total of 671 Chinese American women from metropolitan Washington, DC and New York city were enrolled to participate in this study. The majority of participants were recruited from on-site community events and some were recruited through public advertisement and referrals. Participants who completed baseline assessment were randomized to one of the three groups: 1) viewing an 18-minute cultural video, 2) viewing an 18-minute generic video, and 3) reading a fact sheet (control group). Participants were interviewed twice after intervention:1) process evaluation 2-4 weeks post intervention regarding participants' feedback on the materials and repeated key measures of knowledge, cultural views, and health beliefs and 2) outcome evaluation six-months post intervention that assesses actual receipt of mammography use.
- Conditions
- Study Chinese Women Who Have Not Adhered to American Cancer Society Mammography Screening Guideline
- Being tested
- Culturally-tailored video
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally-tailored videoBehavioural
A 18 minute DVD made in Chinese language (i.e. Mandarin and Cantonese)
| Study group | Role | What they receive |
|---|---|---|
| Culturally-tailored video | Other | The culturally-tailored video was designed to focus on Chinese women's cultural health beliefs and align with Chinese customs, norms, and values, which includes two segments: 1) a soap-opera and 2) recommendation from a Chinese female physician. Receives: Behavioral: Culturally-tailored video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of mammography screening
Measured: six month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2010 (estimated)
- Study startJul 2005
- Primary completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Study Chinese Women Who Have Not Adhered to American Cancer Society Mammography Screening GuidelineStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 671 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc., National Cancer Institute (NCI), Susan G. Komen Breast Cancer Foundation
- Responsible party
- Principal investigator, Judy Wang, Georgetown University
- Investigators
- Judy H Wang, Ph.D., Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261520
- Sponsor's protocol ID
- GU 2005-167
- Other IDs
- MRSGT-05-104-01-CPPB, R03CA117552
- Status last verified
- Apr 2012
- First submitted
- 15 Dec 2010
- Last updated
- 24 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Wang JH, Mandelblatt JS, Liang W, Yi B, Ma IJ, Schwartz MD. Knowledge, cultural, and attitudinal barriers to mammography screening among nonadherent immigrant Chinese women: ever versus never screened status. Cancer. 2009 Oct 15;115(20):4828-38. doi: 10.1002/cncr.24517.
PubMed 19645031Wang JH, Sheppard VB, Liang W, Ma GX, Maxwell AE. Recruiting Chinese Americans into cancer screening intervention trials: strategies and outcomes. Clin Trials. 2014 Apr;11(2):167-77. doi: 10.1177/1740774513518849. Epub 2014 Feb 24.
PubMed 24567288
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Adherence to Mammography Use in Chinese Women
- ClinicalTrials.gov ID
- NCT01261520
- Acronym / sponsor ID
- GU 2005-167
- Conditions
- Study Chinese Women Who Have Not Adhered to American Cancer Society Mammography Screening Guideline
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 671 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc., National Cancer Institute (NCI), Susan G. Komen Breast Cancer Foundation
- Study start
- Jul 2005
- Primary completion
- Aug 2009 (actual)
- First posted
- 16 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examined whether a culturally-tailored video has a greater impact on increasing mammography use in Chinese American women and improving barriers to mammography screening compared to a generic, non-tailored video and a printed fact sheet (control group).
Detailed description
This study examined the efficacy of a culturally-tailored video in increasing mammography use among non-adherent Chinese women (vs. a generic video and control fact sheet). A total of 671 Chinese American women from metropolitan Washington, DC and New York city were enrolled to participate in this study. The majority of participants were recruited from on-site community events and some were recruited through public advertisement and referrals. Participants who completed baseline assessment were randomized to one of the three groups: 1) viewing an 18-minute cultural video, 2) viewing an 18-minute generic video, and 3) reading a fact sheet (control group). Participants were interviewed twice after intervention:1) process evaluation 2-4 weeks post intervention regarding participants' feedback on the materials and repeated key measures of knowledge, cultural views, and health beliefs and 2) outcome evaluation six-months post intervention that assesses actual receipt of mammography use.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Culturally-tailored video | Other | Behavioral: Culturally-tailored videoThe culturally-tailored video was designed to focus on Chinese women's cultural health beliefs and align with Chinese customs, norms, and values, which includes two segments: 1) a soap-opera and 2) recommendation from a Chinese female physician. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chinese American women had not had a mammography in the past 12 months
- Chinese American women had no personal history of breast cancer
- Chinese American women had no mammogram scheduled when enrolled
Key exclusion criteria (2 listed)
- Non-Chinese Women
- Regular mammography users
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturally-tailored videoA 18 minute DVD made in Chinese language (i.e. Mandarin and Cantonese) | Behavioural | Culturally-tailored video |
Primary outcome
Receipt of mammography screening
Time frame: six month post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2012.
- Results publication: PubMed 19645031Wang JH, Mandelblatt JS, Liang W, Yi B, Ma IJ, Schwartz MD. Knowledge, cultural, and attitudinal barriers to mammography screening among nonadherent immigrant Chinese women: ever versus never screened status. Cancer. 2009 Oct 15;115(20):4828-38. doi: 10.1002/cncr.24517.
- Derived from this study: PubMed 24567288Wang JH, Sheppard VB, Liang W, Ma GX, Maxwell AE. Recruiting Chinese Americans into cancer screening intervention trials: strategies and outcomes. Clin Trials. 2014 Apr;11(2):167-77. doi: 10.1177/1740774513518849. Epub 2014 Feb 24.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judy H Wang, Ph.D. principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Culturally-tailored video in people with Study Chinese Women Who Have Not Adhered to American Cancer Society Mammography Screening Guideline, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Receipt of mammography screening (time frame: six month post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01261520, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2012.