Breast CancerPhase 1NCT00247013
Automated Tele Counseling for Screening Mammography
A Phase 1 study testing Breast Cancer Screening Compliance in people with Breast Cancer, run by Boston Medical Center at 1 site in United States.
Trial summary
The purpose and aim of this study is to test the use of a computer-based, automated telecommunications system and its effectiveness in increasing the rates of regular screening mammography among women ages 50-74. Read more about this study
- Who is it for?
- Ages 50 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Breast Cancer Screening Compliance
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,120 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1996to Jan 2006
- Phase
- Phase 1
- 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 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 50-74
- A recent (within the last 6 months) negative screening mammogram
Who cannot join
- Lack a permanent address or planning to move from the Boston area during the study period
- No home telephone or no touch tone service
- Cannot use a telephone unassisted
- Cannot understand conversational English over the telephone
- Major medical illness that would preclude participation
- History of breast cancer
- Mammography or other breast diagnostic procedures (except CBE) or therapeutic procedures since the last screening mammogram
- Another member of household enrolled in the study (to eliminate possible study contamination)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose and aim of this study is to test the use of a computer-based, automated telecommunications system and its effectiveness in increasing the rates of regular screening mammography among women ages 50-74. The system will not only help in scheduling appointments but will help women in overcoming any barriers that may deter them from having the procedure at all. The programs are designed to be user friendly and easy to implement in clinical practice.
Read the detailed description
The primary goal of this project is to evaluate the effectiveness and acceptability of a computer-based telecommunications system for increasing rates of regular screening mammography among women ages 50-74. The Telephone-Linked-Communications for Mammography Screening (TLC-M) is designed to educate, advise and motivate women to have regular screening mammograms. There will be two versions of TLC-M: one for women who are coming due for their annual screening mammography ("pre-due" women) and one for women who have missed their annual mammogram ("past-due" women). TLC-M uses a real human voice to speak to the women on the telephone; the subjects communicate by using the touch tone keypad on their telephones. The intervention will consist of up to three automated telephone conversations. During the call TLC-M assesses the woman's willingness to have a mammogram, helps interested women schedule a mammogram, and identifies and addresses difficulties or barriers she might have in getting a mammogram. This study will consist of two linked randomized controlled trials. We will recruit 2,120 participants over 12 months from two radiology departments. Three to four months prior to their due date for an annual screening mammogram, these women will receive a reminder letter to schedule a mammogram. In addition, a random sample of them will use TLC-M. All participants in this "pre-due" intervention study will be evaluated 3 months after their due date to determine whether or not they obtained a mammogram. Of the women who received the letter only in the first trial, those who did not obtain a mammogram during the observation period will enter a "past due" intervention trial. These women will be randomly assigned to receive a "past due" reminder letter or to use the TLC-M. Four months later, participants will be evaluated to determine whether they had a mammogram. For both trials mammography rates of those women who used the TLC-M and those who did not will be statistically compared.
- Conditions
- Breast Cancer
- Being tested
- Breast Cancer Screening Compliance
- Keywords
- automated telephone system, breast cancer, cancer prevention, intervention, mammography, screening
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Cancer Screening ComplianceBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of women who have repeat screening mammogram
Secondary outcomes (1)
Evaluation of intervention for those women who used TLC-M
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2005 (estimated)
- Study startJan 1996
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 2,120 participants
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Investigators
- Robert Friedman, MD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247013
- Sponsor's protocol ID
- R01CA084447-01
- Other IDs
- National Cancer Institute
- Status last verified
- Sep 2010
- First submitted
- 28 Oct 2005
- Last updated
- 22 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Tele Counseling for Screening Mammography
- ClinicalTrials.gov ID
- NCT00247013
- Acronym / sponsor ID
- R01CA084447-01
- Conditions
- Breast Cancer
- Keywords
- automated telephone system, breast cancer, cancer prevention, intervention, mammography, screening
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,120 participants
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- Jan 1996
- Study completion
- Jan 2006
- First posted
- 1 Nov 2005 (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.
The purpose and aim of this study is to test the use of a computer-based, automated telecommunications system and its effectiveness in increasing the rates of regular screening mammography among women ages 50-74. The system will not only help in scheduling appointments but will help women in overcoming any barriers that may deter them from having the procedure at all. The programs are designed to be user friendly and easy to implement in clinical practice.
Detailed description
The primary goal of this project is to evaluate the effectiveness and acceptability of a computer-based telecommunications system for increasing rates of regular screening mammography among women ages 50-74. The Telephone-Linked-Communications for Mammography Screening (TLC-M) is designed to educate, advise and motivate women to have regular screening mammograms. There will be two versions of TLC-M: one for women who are coming due for their annual screening mammography ("pre-due" women) and one for women who have missed their annual mammogram ("past-due" women). TLC-M uses a real human voice to speak to the women on the telephone; the subjects communicate by using the touch tone keypad on their telephones. The intervention will consist of up to three automated telephone conversations. During the call TLC-M assesses the woman's willingness to have a mammogram, helps interested women schedule a mammogram, and identifies and addresses difficulties or barriers she might have in getting a mammogram. This study will consist of two linked randomized controlled trials. We will recruit 2,120 participants over 12 months from two radiology departments. Three to four months prior to their due date for an annual screening mammogram, these women will receive a reminder letter to schedule a mammogram. In addition, a random sample of them will use TLC-M. All participants in this "pre-due" intervention study will be evaluated 3 months after their due date to determine whether or not they obtained a mammogram. Of the women who received the letter only in the first trial, those who did not obtain a mammogram during the observation period will enter a "past due" intervention trial. These women will be randomly assigned to receive a "past due" reminder letter or to use the TLC-M. Four months later, participants will be evaluated to determine whether they had a mammogram. For both trials mammography rates of those women who used the TLC-M and those who did not will be statistically compared.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 50 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ages 50-74
- A recent (within the last 6 months) negative screening mammogram
Key exclusion criteria (8 listed)
- Lack a permanent address or planning to move from the Boston area during the study period
- No home telephone or no touch tone service
- Cannot use a telephone unassisted
- Cannot understand conversational English over the telephone
- Major medical illness that would preclude participation
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 |
|---|---|---|
| Breast Cancer Screening Compliance | Behavioural | – |
Primary outcome
Number of women who have repeat screening mammogram
1 secondary outcome
Evaluation of intervention for those women who used TLC-M
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 22 Feb 2016.
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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.
Robert Friedman, MD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Breast Cancer Screening Compliance in people with Breast Cancer, run by Boston Medical Center 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 2 inclusion and 8 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 22 Feb 2016. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of women who have repeat screening mammogram. 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 22 Feb 2016.