Colorectal CancerSMILESNCT03174444
Small Media Interventions to Increase Colorectal Cancer Screening Among Chinese Americans
A study testing Small Media in people with Colorectal Cancer and Cancer Screening, run by University of California, San Francisco at 1 site in United States.
Trial summary
There have been few studies of small media interventions to promote colorectal cancer screening among Chinese Americans. Based on the results of strong preliminary studies on the promotion of colorectal cancer screening among Asian American populations, this community-academic research team propose to develop a… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Cancer Screening
- What is being tested?
- Small Media
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,707 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2017to 30 Sep 2019
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Not up-to-date for colorectal cancer screening; self-identified as Chinese or Chinese American, or Asian who speak Chinese, or Asian born in China.
Who cannot join
- Not eligible for colorectal cancer screening for any reason.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
There have been few studies of small media interventions to promote colorectal cancer screening among Chinese Americans. Based on the results of strong preliminary studies on the promotion of colorectal cancer screening among Asian American populations, this community-academic research team propose to develop a culturally and linguistically appropriate traditional small media print brochure and a novel small media electronic audio-visual application accessible through mobile applications and through a website to promote CRC screening in English, Cantonese, and Mandarin. The team will test in a randomized controlled trial in 3 healthcare systems the efficacy of a combination of these small media interventions and a mailed patient reminder compared to usual care on increasing CRC screening among Chinese American patients.
Read the detailed description
Chinese Americans are the largest group of Asian Americans, the fastest growing racial population in the U.S. Colorectal cancer is the second most common cancer among Chinese Americans. Screening reduces colorectal cancer mortality and is cost-effective but remains underutilized. Asian Americans and Chinese Americans are less likely than non-Hispanic whites to be screened for colorectal cancer. Factors associated with lack of screening among Asian Americans include recent immigration, lower education, lower English fluency, lack of knowledge, patient-physician language discordance, and lack of physician recommendation.
Although small media and client-reminders are effective in increasing colorectal cancer screening in the general population, no randomized controlled trial has assessed the effect of such interventions on Chinese Americans, particularly those who are limited English proficient. Building on an established community-based participatory research network and strong preliminary studies, the team propose to develop a culturally and linguistically appropriate booklet (small print media) and an audio-visual application accessible through mobile devices and a website (small electronic media) to promote screening. Through an innovative approach that links community organizations that have cultural and linguistic expertise to healthcare systems that have many Chinese American patients, the investigators will test the effect of combining these small media materials and a mailed patient reminder on the rate of screening for colorectal cancer screening among Chinese Americans in this Small Media Interventions for Limited English Speakers (SMILES). The investigators have developed English and Chinese (Cantonese and Mandarin) small print and electronic media materials to promote colorectal cancer screening among Chinese Americans. This RCT will compare the efficacy of a combination of mailed patient reminder and small print and electronic media versus usual care among Chinese American patients who are not up-to-date for colorectal cancer screening recruited from 3 healthcare systems in a randomized controlled trial.
- Conditions
- Colorectal Cancer, Cancer Screening
- Being tested
- Small Media
- Keywords
- Chinese American, Asian American, Colorectal cancer screening, Print materials
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small MediaBehavioural
Bilingual brochures and access to bilingual website
| Study group | Role | What they receive |
|---|---|---|
| Small Media | Experimental | Participants receive bilingual brochures and access to bilingual website about colorectal cancer screening. Receives: Behavioral: Small Media |
| Control | No intervention | Participants receive no information about colorectal cancer screening from the study during the intervention period, but may receive usual care from health care provider. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal Cancer Screening
Up-to-date receipt of any colorectal cancer screening
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start15 Aug 2017
- Primary completion30 Oct 2018
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individual randomized controlled trial with two arms.
- Masking
- None (open label)
- Enrolment
- 1,707 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, NICOS Chinese Health Coalition, Chinese Community Health Resource Center, Northeast Medical Services, Chinese Hospital Clinics
- Responsible party
- Sponsor
- Investigators
- Tung Nguyen, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03174444
- Sponsor's protocol ID
- 174519
- Other IDs
- 3U48DP004998-03S6
- Acronym
- SMILES
- Status last verified
- Feb 2020
- First submitted
- 30 May 2017
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Media Interventions to Increase Colorectal Cancer Screening Among Chinese Americans
- ClinicalTrials.gov ID
- NCT03174444
- Acronym / sponsor ID
- SMILES / 174519
- Conditions
- Colorectal Cancer, Cancer Screening
- Keywords
- Chinese American, Asian American, Colorectal cancer screening, Print materials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,707 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, NICOS Chinese Health Coalition, Chinese Community Health Resource Center, Northeast Medical Services, Chinese Hospital Clinics
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 2 Jun 2017 (actual)
- 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.
There have been few studies of small media interventions to promote colorectal cancer screening among Chinese Americans. Based on the results of strong preliminary studies on the promotion of colorectal cancer screening among Asian American populations, this community-academic research team propose to develop a culturally and linguistically appropriate traditional small media print brochure and a novel small media electronic audio-visual application accessible through mobile applications and through a website to promote CRC screening in English, Cantonese, and Mandarin. The team will test in a randomized controlled trial in 3 healthcare systems the efficacy of a combination of these small media interventions and a mailed patient reminder compared to usual care on increasing CRC screening among Chinese American patients.
Detailed description
Chinese Americans are the largest group of Asian Americans, the fastest growing racial population in the U.S. Colorectal cancer is the second most common cancer among Chinese Americans. Screening reduces colorectal cancer mortality and is cost-effective but remains underutilized. Asian Americans and Chinese Americans are less likely than non-Hispanic whites to be screened for colorectal cancer. Factors associated with lack of screening among Asian Americans include recent immigration, lower education, lower English fluency, lack of knowledge, patient-physician language discordance, and lack of physician recommendation.
Although small media and client-reminders are effective in increasing colorectal cancer screening in the general population, no randomized controlled trial has assessed the effect of such interventions on Chinese Americans, particularly those who are limited English proficient. Building on an established community-based participatory research network and strong preliminary studies, the team propose to develop a culturally and linguistically appropriate booklet (small print media) and an audio-visual application accessible through mobile devices and a website (small electronic media) to promote screening. Through an innovative approach that links community organizations that have cultural and linguistic expertise to healthcare systems that have many Chinese American patients, the investigators will test the effect of combining these small media materials and a mailed patient reminder on the rate of screening for colorectal cancer screening among Chinese Americans in this Small Media Interventions for Limited English Speakers (SMILES). The investigators have developed English and Chinese (Cantonese and Mandarin) small print and electronic media materials to promote colorectal cancer screening among Chinese Americans. This RCT will compare the efficacy of a combination of mailed patient reminder and small print and electronic media versus usual care among Chinese American patients who are not up-to-date for colorectal cancer screening recruited from 3 healthcare systems in a randomized controlled trial.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Individual randomized controlled trial with two arms.
| Arm | Type | Receives |
|---|---|---|
| Small Media | Experimental | Behavioral: Small MediaParticipants receive bilingual brochures and access to bilingual website about colorectal cancer screening. |
| Control | No intervention | –Participants receive no information about colorectal cancer screening from the study during the intervention period, but may receive usual care from health care provider. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Not up-to-date for colorectal cancer screening; self-identified as Chinese or Chinese American, or Asian who speak Chinese, or Asian born in China.
Key exclusion criteria (1 listed)
- Not eligible for colorectal cancer screening for any reason.
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 |
|---|---|---|
| Small MediaBilingual brochures and access to bilingual website | Behavioural | Small Media |
Primary outcome
Colorectal Cancer Screening
Time frame: 9 months
Up-to-date receipt of any colorectal cancer screening
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 11 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Tung Nguyen, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Small Media in people with Colorectal Cancer and Cancer Screening, run by University of California, San Francisco 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 1 inclusion and 1 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 11 Feb 2020. 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.
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?
Colorectal Cancer Screening (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2020.