Breast CancerNCT01292200
Breast Health in Chinese American Women
A study testing watch DVD and small group discussion and watch DVD in people with Breast Cancer, run by Georgetown University at 3 sites in United States.
Trial summary
This four-and-a-half-year study will test the efficacy of viewing a theoretically based and culturally sensitive video followed by group discussion (vs. single viewing) in increasing mammography use. Read more about this study
- Who is it for?
- Ages 42 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- watch DVD and small group discussion and watch DVD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 954 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2010to 21 Dec 2016
- Phase
- Interventional
- 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 42 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First generation Chinese women
- Aged 42 and older
- Have not had a mammogram in the past 2 years
- Have never had breast cancer
- Lived in the metropolitan DC, southern CA, and NY suburb; AND
- Have no mammography screening scheduled in the next 6 month from time of enrollment
Who cannot join
- Short-term visitors
- US-born Chinese Americans
Trial locations and contacts
3 sites in 1 country.
United States3 sites
UCLA
Los Angeles, California, 90095
Temple University
Philadelphia, Pennsylvania, 19122
Georgetown University
Washington D.C., District of Columbia, 20007
About this study
Official title: A RCT to Promote Mammography Adherence Among Chinese Immigrant Women
This four-and-a-half-year study will test the efficacy of viewing a theoretically based and culturally sensitive video followed by group discussion (vs. single viewing) in increasing mammography use. The results of this study will lead cancer control efforts to effectively decrease breast cancer screening disparities experienced by Chinese-America women.
Read the detailed description
We will conduct a 4.5-year community-based RCT to study the impact of intervention approaches (small-group video discussion vs. single video mode) on mammography used among Chinese immigrant women. The small-group video discussion will be led by trained Chinese community health educators and trained bilingual research staff using a standardized structured protocol at all sites. In the single video mode, we will mail the intervention materials to women to view and/or read at home. We will recruit 974 Chinese women through our strong and well-established Chinese community partnerships in the metropolitan areas of Washington, DC (Lead PI: Dr. Judy Wang, Georgetown University-GU), New York (Site PI: Dr. Grace Ma at Temple University), and southern California (Site PI: Dr. Annette Maxwell, University of California, Los Angeles-UCLA). Participants' eligibility are listed under "eligibility criteria". We will not enroll US-born Chinese women as they are least likely to face cultural and language barriers to mammography and less likely to engage in our small-group discussion, which will be conducted in Chinese languages. Also, we will not enroll short-term visitors as our study involves four interviews over a 2-year period.
- Conditions
- Breast Cancer
- Being tested
- watch DVD and small group discussion, watch DVD
- Keywords
- Chinese women, Mammography, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
watch DVD and small group discussionBehavioural
Women in the small-group discussion mode will be called by their community educators to determine possible dates, times, and places for group meetings. The small group sessions will be conducted near the participants' homes. Each small-group will consist of 5-10 participants who will first view a 20-minute video together and then discuss the content of the video as well as their barriers to screening for about 30 minutes. A community educator and an RA at the study site will facilitate the discussion in Chinese languages according to a structured guide.
watch DVDBehavioural
Women in the single video mode will receive a cultural video along with an information sheet on local free and low-cost screening programs by mail.
| Study group | Role | What they receive |
|---|---|---|
| watch DVD and small group discussion | Experimental | Participants will watch the video in a group and discuss the video. Receives: Behavioral: watch DVD and small group discussion |
| watch video only | Placebo comparator | watch a 22 minutes long video at home by herself. Receives: Behavioral: watch DVD |
What is being measured
The primary outcome is the main question the study is designed to answer.
3rd interview about receipt of mammography screening
Measure the effect of small group video discussion on mammography screening adherence.
Measured: 6-month post-intervention
Secondary outcomes (1)
4th interview about receipt of mammography screening
Measure the effect of small group video discussion on repeated mammography screening adherence.
Measured: 21-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 posted9 Feb 2011 (estimated)
- Study startJul 2010
- Primary completion21 Dec 2016
- Study completion21 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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 N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 954 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Temple University, University of California, Los Angeles, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Judy Wang, Georgetown University
- Investigators
- Judy (Huei-Yu) Wang, Ph.D., Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292200
- Sponsor's protocol ID
- 2010-185
- Other IDs
- R01CA142941-01A1
- Status last verified
- Jul 2016
- First submitted
- 7 Feb 2011
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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, Liang W, Schwartz MD, Lee MM, Kreling B, Mandelblatt JS. Development and evaluation of a culturally tailored educational video: changing breast cancer-related behaviors in Chinese women. Health Educ Behav. 2008 Dec;35(6):806-20. doi: 10.1177/1090198106296768. Epub 2007 Jun 29.
PubMed 17602099Tan NQP, Ma GX, Maxwell AE, Brown RL, Zhou K, Loh A, Young L, Volk RJ, Lu Q, Wang JH. The impact of a small-group mammography video discussion on promoting screening uptake among nonadherent Chinese American immigrant women: A randomized controlled trial. Cancer. 2025 Jan 1;131(1):e35524. doi: 10.1002/cncr.35524. Epub 2024 Sep 10.
PubMed 39257218
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RCT to Promote Mammography Adherence Among Chinese Immigrant Women
- ClinicalTrials.gov ID
- NCT01292200
- Acronym / sponsor ID
- 2010-185
- Conditions
- Breast Cancer
- Keywords
- Chinese women, Mammography, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 954 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- Temple University, University of California, Los Angeles, National Cancer Institute (NCI)
- Study start
- Jul 2010
- Primary completion
- 21 Dec 2016 (actual)
- Study completion
- 21 Dec 2016 (actual)
- First posted
- 9 Feb 2011 (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 four-and-a-half-year study will test the efficacy of viewing a theoretically based and culturally sensitive video followed by group discussion (vs. single viewing) in increasing mammography use. The results of this study will lead cancer control efforts to effectively decrease breast cancer screening disparities experienced by Chinese-America women.
Detailed description
We will conduct a 4.5-year community-based RCT to study the impact of intervention approaches (small-group video discussion vs. single video mode) on mammography used among Chinese immigrant women. The small-group video discussion will be led by trained Chinese community health educators and trained bilingual research staff using a standardized structured protocol at all sites. In the single video mode, we will mail the intervention materials to women to view and/or read at home. We will recruit 974 Chinese women through our strong and well-established Chinese community partnerships in the metropolitan areas of Washington, DC (Lead PI: Dr. Judy Wang, Georgetown University-GU), New York (Site PI: Dr. Grace Ma at Temple University), and southern California (Site PI: Dr. Annette Maxwell, University of California, Los Angeles-UCLA). Participants' eligibility are listed under "eligibility criteria". We will not enroll US-born Chinese women as they are least likely to face cultural and language barriers to mammography and less likely to engage in our small-group discussion, which will be conducted in Chinese languages. Also, we will not enroll short-term visitors as our study involves four interviews over a 2-year period.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| watch DVD and small group discussion | Experimental | Behavioral: watch DVD and small group discussionParticipants will watch the video in a group and discuss the video. |
| watch video only | Placebo comparator | Behavioral: watch DVDwatch a 22 minutes long video at home by herself. |
Who may qualify
- Ages
- 42 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- First generation Chinese women
- Aged 42 and older
- Have not had a mammogram in the past 2 years
- Have never had breast cancer
- Lived in the metropolitan DC, southern CA, and NY suburb; AND
Key exclusion criteria (2 listed)
- Short-term visitors
- US-born Chinese Americans
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 |
|---|---|---|
| watch DVD and small group discussionWomen in the small-group discussion mode will be called by their community educators to determine possible dates, times, and places for group meetings. The small group sessions will be conducted near the participants' homes. Each small-group will consist of 5-10 participants who will first view a 20-minute video together and then discuss the content of the video as well as their barriers to screening for about 30 minutes. A community educator and an RA at the study site will facilitate the discussion in Chinese languages according to a structured guide. | Behavioural | watch DVD and small group discussion |
| watch DVDWomen in the single video mode will receive a cultural video along with an information sheet on local free and low-cost screening programs by mail. | Behavioural | watch video only |
Primary outcome
3rd interview about receipt of mammography screening
Time frame: 6-month post-intervention
Measure the effect of small group video discussion on mammography screening adherence.
1 secondary outcome
4th interview about receipt of mammography screening
Time frame: 21-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 2 Jul 2017.
- Background: 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.
- Background: PubMed 17602099Wang JH, Liang W, Schwartz MD, Lee MM, Kreling B, Mandelblatt JS. Development and evaluation of a culturally tailored educational video: changing breast cancer-related behaviors in Chinese women. Health Educ Behav. 2008 Dec;35(6):806-20. doi: 10.1177/1090198106296768. Epub 2007 Jun 29.
- Derived from this study: PubMed 39257218Tan NQP, Ma GX, Maxwell AE, Brown RL, Zhou K, Loh A, Young L, Volk RJ, Lu Q, Wang JH. The impact of a small-group mammography video discussion on promoting screening uptake among nonadherent Chinese American immigrant women: A randomized controlled trial. Cancer. 2025 Jan 1;131(1):e35524. doi: 10.1002/cncr.35524. Epub 2024 Sep 10.
- Individual participant dataSharing planned: Undecided
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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 (Huei-Yu) Wang, Ph.D. principal investigator
Georgetown University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing watch DVD and small group discussion and watch DVD in people with Breast Cancer, run by Georgetown University at 3 sites 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 6 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
3rd interview about receipt of mammography screening (time frame: 6-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 NCT01292200, which also lists 3 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 2 Jul 2017.