Breast Cancer ScreeningPhase 3NCT00287040
Breast Cancer Screening Via Computer V. Phone
A Phase 3 study testing Tailored, interactive intervention for mammography screening in people with Breast Cancer Screening, run by Indiana University at 2 sites in United States.
Trial summary
The purpose of this study is to compare mammography adherence among women receiving tailored, interactive mammography interventions via DVD and telephone counseling to usual care. Read more about this study
- Who is it for?
- Ages 41 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Screening
- What is being tested?
- Tailored, interactive intervention for mammography screening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,686 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2007to Jun 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 41 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Must have been a member of their HMO/insurance plan for at least 15 months with records indicating no mammogram (screening or diagnostic) in that 15-month period
- Current member of the plan at time of study enrollment
- No history of breast cancer diagnosis
- Complete telephone number and mailing address
Who cannot join
- • Any claim submitted for a mammogram (screening or diagnostic) in the last 15 months within the HMO/insurance plan or an outside source
- Previous breast cancer diagnosis
- Incomplete telephone number or mailing address
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University
Durham, North Carolina
Indiana University
Indianapolis, Indiana, 46202
About this study
The purpose of this study is to compare mammography adherence among women receiving tailored, interactive mammography interventions via DVD and telephone counseling to usual care.
Read the detailed description
Efficacy Study - We will use stratified block randomization based on race to ensure that the treatment groups maintain comparable race composition. Participants will be randomly assigned to one of the intervention groups or to usual care. Intervention Group 1 will receive, by mail, a DVD version of the interactive computer program; based on responses to its queries, the program will supply immediate feedback to promote mammography. Intervention Group 2 will receive a telephone version of the tailored intervention delivered by a counselor stationed at a computer. The counselor will use questions from the interactive program and deliver messages the program generates in response to each woman's answers. A third group will receive usual care. All women will be asked to participate in 6-month and 21-month follow-up telephone interviews querying stage of mammography adherence and beliefs.
- Conditions
- Breast Cancer Screening
- Being tested
- Tailored, interactive intervention for mammography screening
- Keywords
- Breast Cancer, Mammography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored, interactive intervention for mammography screeningBehavioural
Follow ups will occur at 6-, 12-, and 21-months in order to determine effectiveness of intervention as well as cost effectiveness and variation based on participant characteristics to facilitate a more effective program for mammography screenings
| Study group | Role | What they receive |
|---|---|---|
| 1 - Usual Care | No intervention | This arm looks at mammogram adherence in those individuals who at this time are not receiving booster mammogram interventions. |
| 2. DVD Intervention | Experimental | This arm will receive the initial information provided in usual care and will also receive booster mammography interventions via DVD. Receives: Behavioral: Tailored, interactive intervention for mammography screening |
| 3. Telephone Counseling | Experimental | This arm will receive the initial information provided in usual care and receive boosters through tailored telephone counseling. Receives: Behavioral: Tailored, interactive intervention for mammography screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
To increase annual mammography adherence
Measured: at 6-, 12-, and 21-Months
Secondary outcomes (1)
Cost-effectiveness of DVD versus telephone survey
Measured: at 6-, 12-, and 21-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2006 (estimated)
- Study startSep 2007
- Primary completionJun 2009
- Study completionJun 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 Breast Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by Indiana 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,686 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Victoria Champion, DNS, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287040
- Sponsor's protocol ID
- 0408-03B
- Other IDs
- R01NR008434, NIH: R01 NR0083434
- Status last verified
- Aug 2008
- First submitted
- 3 Feb 2006
- Last updated
- 17 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gathirua-Mwangi WG, Monahan PO, Stump T, Rawl SM, Skinner CS, Champion VL. Mammography Adherence in African-American Women: Results of a Randomized Controlled Trial. Ann Behav Med. 2016 Feb;50(1):70-8. doi: 10.1007/s12160-015-9733-0.
PubMed 26416127Champion VL, Rawl SM, Bourff SA, Champion KM, Smith LG, Buchanan AH, Fish LJ, Monahan PO, Stump TE, Springston JK, Gathirua-Mwangi WG, Skinner CS. Randomized trial of DVD, telephone, and usual care for increasing mammography adherence. J Health Psychol. 2016 Jun;21(6):916-26. doi: 10.1177/1359105314542817. Epub 2014 Jul 28.
PubMed 25070967
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Screening Via Computer V. Phone
- ClinicalTrials.gov ID
- NCT00287040
- Acronym / sponsor ID
- 0408-03B
- Conditions
- Breast Cancer Screening
- Keywords
- Breast Cancer, Mammography
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,686 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), National Cancer Institute (NCI)
- Study start
- Sep 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 6 Feb 2006 (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 of this study is to compare mammography adherence among women receiving tailored, interactive mammography interventions via DVD and telephone counseling to usual care.
Detailed description
Efficacy Study - We will use stratified block randomization based on race to ensure that the treatment groups maintain comparable race composition. Participants will be randomly assigned to one of the intervention groups or to usual care. Intervention Group 1 will receive, by mail, a DVD version of the interactive computer program; based on responses to its queries, the program will supply immediate feedback to promote mammography. Intervention Group 2 will receive a telephone version of the tailored intervention delivered by a counselor stationed at a computer. The counselor will use questions from the interactive program and deliver messages the program generates in response to each woman's answers. A third group will receive usual care. All women will be asked to participate in 6-month and 21-month follow-up telephone interviews querying stage of mammography adherence and beliefs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 - Usual Care | No intervention | –This arm looks at mammogram adherence in those individuals who at this time are not receiving booster mammogram interventions. |
| 2. DVD Intervention | Experimental | Behavioral: Tailored, interactive intervention for mammography screeningThis arm will receive the initial information provided in usual care and will also receive booster mammography interventions via DVD. |
| 3. Telephone Counseling | Experimental | Behavioral: Tailored, interactive intervention for mammography screeningThis arm will receive the initial information provided in usual care and receive boosters through tailored telephone counseling. |
Who may qualify
- Ages
- 41 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Must have been a member of their HMO/insurance plan for at least 15 months with records indicating no mammogram (screening or diagnostic) in that 15-month period
Key exclusion criteria (3 listed)
- • Any claim submitted for a mammogram (screening or diagnostic) in the last 15 months within the HMO/insurance plan or an outside source
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 |
|---|---|---|
| Tailored, interactive intervention for mammography screeningFollow ups will occur at 6-, 12-, and 21-months in order to determine effectiveness of intervention as well as cost effectiveness and variation based on participant characteristics to facilitate a more effective program for mammography screenings | Behavioural | 2. DVD Intervention, 3. Telephone Counseling |
Primary outcome
To increase annual mammography adherence
Time frame: at 6-, 12-, and 21-Months
1 secondary outcome
Cost-effectiveness of DVD versus telephone survey
Time frame: at 6-, 12-, and 21-months
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 17 May 2012.
- Derived from this study: PubMed 26416127Gathirua-Mwangi WG, Monahan PO, Stump T, Rawl SM, Skinner CS, Champion VL. Mammography Adherence in African-American Women: Results of a Randomized Controlled Trial. Ann Behav Med. 2016 Feb;50(1):70-8. doi: 10.1007/s12160-015-9733-0.
- Derived from this study: PubMed 25070967Champion VL, Rawl SM, Bourff SA, Champion KM, Smith LG, Buchanan AH, Fish LJ, Monahan PO, Stump TE, Springston JK, Gathirua-Mwangi WG, Skinner CS. Randomized trial of DVD, telephone, and usual care for increasing mammography adherence. J Health Psychol. 2016 Jun;21(6):916-26. doi: 10.1177/1359105314542817. Epub 2014 Jul 28.
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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.
Victoria Champion, DNS principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tailored, interactive intervention for mammography screening in people with Breast Cancer Screening, run by Indiana University at 2 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 4 inclusion and 3 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 17 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
To increase annual mammography adherence (time frame: at 6-, 12-, and 21-Months). 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 NCT00287040, 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 17 May 2012.