Breast CancerNCT01972048
Mobile Phone Multimedia Messaging Intervention for Breast Cancer Screening
A study testing mMammogram and Print brochure in people with Breast Cancer, run by University of Minnesota at 1 site in United States.
Trial summary
Korean American (KA) women have among the highest breast cancer mortality rates and lowest breast cancer screening rates of U.S. American women across racial/ethical groups. This innovative project seeks to harness mobile phone technology as a means to take preventative health care to a new level among this… Read more about this study
- Who is it for?
- Ages 40 to 79 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- mMammogram and Print brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to May 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 40 to 79 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Korean American immigrant women
- Aged 40-79
- Residence in Minnesota
- Possession of mobile phone with text-message function
- Possession of active email account
Who cannot join
- Mammogram receipt within the past 2 years
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, 55455
About this study
Official title: Mobile Phone Multimedia Messaging Intervention for Breast Cancer Screening: Intervention Phase
Korean American (KA) women have among the highest breast cancer mortality rates and lowest breast cancer screening rates of U.S. American women across racial/ethical groups. This innovative project seeks to harness mobile phone technology as a means to take preventative health care to a new level among this population. Using the Fogg Behavioral Model this study proposes to develop a mobile phone-based intervention designed to motivate KA women to undergo an annual mammogram (mMammogram). The overall study aim is to develop and assess the feasibility and effectiveness of a 7-day long mMammogram intervention designed to persuade KA women to undergo breast cancer screening.
Read the detailed description
Specific aims over the three-year period include the following: (1) The first year will be devoted to intervention and protocol development. A major emphasis in year 1 will be developing the community advisory board (CAB), conducting a series of pre-intervention focus groups, and working with pertinent persuasive technology consultants to develop and pilot-test the intervention. (2) The second year and the first half of the third year will focus on delivery of the intervention. (3) the second half of the third year will be devoted to data analysis and dissemination.
- Conditions
- Breast Cancer
- Being tested
- mMammogram, Print brochure
- Keywords
- breast cancer, breast cancer screening, mammogram
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mMammogramBehavioural
Text messages delivered via mobile app to participants designed to inform them about breast cancer screening and encourage them to schedule a mammogram.
Print brochureOther
Mailed print brochure about breast cancer screening and community resources.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Participants in the control group will receive the mailed print brochure about breast cancer screening and community resources. Receives: Other: Print brochure |
| Intervention group | Experimental | Participants will receive the mMammogram intervention. Receives: Behavioral: mMammogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mammogram receipt
The receipt of mammogram (or scheduled appointment) will be measured by self-report.
Measured: 1 week
Secondary outcomes (4)
Breast cancer knowledge
Breast cancer knowledge will be measured by means of McCance, Mooney and Smith's ten-item "Breast Cancer Knowledge" test.
Measured: 1 week
Breast cancer health beliefs
Change in health beliefs will be measured using Champion's Health Belief Model scales.
Measured: 1 week
Culture specific attitudes toward breast cancer
Culture-specific attitudes toward breast cancer screening, such as modesty, will be measured utilizing six items from Tang and colleagues and fatalistic attitudes toward breast cancer will be measured by means of three items from Taylor and colleagues.
Measured: 1 week
Participant intent to undergo screening
We will measure participant intent to undergo screening by use of an adapted version of the transtheoretical model.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2013 (estimated)
- Study startJan 2014
- Primary completionMar 2016 (estimated)
- Study completionMay 2016 (estimated)
Why it stopped: PI Left University
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 University of MinnesotaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hee Y Lee, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01972048
- Sponsor's protocol ID
- 2013NTLS063
- Status last verified
- Jan 2018
- First submitted
- 24 Oct 2013
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee H, Ghebre R, Le C, Jang YJ, Sharratt M, Yee D. Mobile Phone Multilevel and Multimedia Messaging Intervention for Breast Cancer Screening: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2017 Nov 7;5(11):e154. doi: 10.2196/mhealth.7091.
PubMed 29113961
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Phone Multimedia Messaging Intervention for Breast Cancer Screening: Intervention Phase
- ClinicalTrials.gov ID
- NCT01972048
- Acronym / sponsor ID
- 2013NTLS063
- Conditions
- Breast Cancer
- Keywords
- breast cancer, breast cancer screening, mammogram
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI Left University
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 30 Oct 2013 (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.
Korean American (KA) women have among the highest breast cancer mortality rates and lowest breast cancer screening rates of U.S. American women across racial/ethical groups. This innovative project seeks to harness mobile phone technology as a means to take preventative health care to a new level among this population. Using the Fogg Behavioral Model this study proposes to develop a mobile phone-based intervention designed to motivate KA women to undergo an annual mammogram (mMammogram). The overall study aim is to develop and assess the feasibility and effectiveness of a 7-day long mMammogram intervention designed to persuade KA women to undergo breast cancer screening.
Detailed description
Specific aims over the three-year period include the following: (1) The first year will be devoted to intervention and protocol development. A major emphasis in year 1 will be developing the community advisory board (CAB), conducting a series of pre-intervention focus groups, and working with pertinent persuasive technology consultants to develop and pilot-test the intervention. (2) The second year and the first half of the third year will focus on delivery of the intervention. (3) the second half of the third year will be devoted to data analysis and dissemination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Print brochureParticipants in the control group will receive the mailed print brochure about breast cancer screening and community resources. |
| Intervention group | Experimental | Behavioral: mMammogramParticipants will receive the mMammogram intervention. |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Korean American immigrant women
- Aged 40-79
- Residence in Minnesota
- Possession of mobile phone with text-message function
- Possession of active email account
Key exclusion criteria (1 listed)
- Mammogram receipt within the past 2 years
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 |
|---|---|---|
| mMammogramText messages delivered via mobile app to participants designed to inform them about breast cancer screening and encourage them to schedule a mammogram. | Behavioural | Intervention group |
| Print brochureMailed print brochure about breast cancer screening and community resources. | Other | Control group |
Primary outcome
Mammogram receipt
Time frame: 1 week
The receipt of mammogram (or scheduled appointment) will be measured by self-report.
4 secondary outcomes
Breast cancer knowledge
Time frame: 1 week
Breast cancer health beliefs
Time frame: 1 week
Culture specific attitudes toward breast cancer
Time frame: 1 week
Participant intent to undergo screening
Time frame: 1 week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- Derived from this study: PubMed 29113961Lee H, Ghebre R, Le C, Jang YJ, Sharratt M, Yee D. Mobile Phone Multilevel and Multimedia Messaging Intervention for Breast Cancer Screening: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2017 Nov 7;5(11):e154. doi: 10.2196/mhealth.7091.
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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.
Hee Y Lee, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mMammogram and Print brochure in people with Breast Cancer, run by University of Minnesota 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 5 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: withdrawn, as of the sponsor's last update on 26 Jan 2018. 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 was withdrawn before enrolling participants, so there are no results.
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?
Mammogram receipt (time frame: 1 week). 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 NCT01972048, which also lists 1 linked publication.
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 26 Jan 2018.