Breast CancerPhase 1/2NCT00967824
Tamoxifen Citrate Decision Aids for Women at Increased Risk of Breast Cancer
A Phase 1/2 study testing informational intervention, questionnaire administration and survey administration in people with Breast Cancer, run by University of Michigan Rogel Cancer Center.
Trial summary
RATIONALE: Evaluating a decision aid that describes the risks and benefits of taking tamoxifen citrate to prevent breast cancer may be helpful for women at increased risk of breast cancer. PURPOSE: This randomized phase I/II trial is studying tamoxifen citrate decision aids for women at increased risk of breast cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- informational intervention, questionnaire administration and survey administration
- How many people
- 1,683 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to Aug 2008
- Phase
- Phase 1/2
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Believed to be at increased risk of breast cancer (risk of ≥ 1.66% over 5 years) according to electronic-based medical data
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Developing and Testing a Tamoxifen Prophylaxis Decision Aid
RATIONALE: Evaluating a decision aid that describes the risks and benefits of taking tamoxifen citrate to prevent breast cancer may be helpful for women at increased risk of breast cancer.
PURPOSE: This randomized phase I/II trial is studying tamoxifen citrate decision aids for women at increased risk of breast cancer.
Read the detailed description
OBJECTIVES:
- To develop and test a decision aid for describing the risks and benefits of taking tamoxifen citrate to prevent primary breast cancer in women at increased risk of breast cancer.
OUTLINE:
- Phase I: Patients are randomized to view 1 of 16 decision aids that vary in terms of how the information is presented based on 5 dimensions: 1) statistical information in pictographs vs plain text, 2) risk information presented with denominators of 100 vs 1000, 3) risk information presented in terms of total vs additional risk, 4) whether the risks of tamoxifen citrate are presented before or after the benefits are presented, and 5) contextual information about other risks the patient faces (all cause mortality, colon cancer, heart attack).
Patients complete baseline and post-test questionnaires.
- Phase II: Patients are randomized to 1 of 3 arms.
- Arm I (control): Patients do not view the decision aid, but complete baseline and post-test questionnaires.
- Arm II (control): Patients complete a baseline questionnaire only. They do not view the decision aid or complete the post-test questionnaire.
- Arm III (intervention): Patients view 1 of 16 decision aids that vary based on 5 factors: 1) providing (or not) comparative information about the average woman's breast cancer risk, 2) sequencing presentation of risks and benefits (risks first vs benefits first), 3) including (or not) a summary table following presentation of risks and benefits, 4) using second vs third person language ("your risk" vs "a person like you"), and 5) presenting the decision as having 2 vs 3 options (taking/not taking a breast cancer prevention drug vs taking tamoxifen citrate/raloxifene, or no drug). Patients also complete baseline and post-test questionnaires.
Patients in both phases complete an online follow-up survey at 3 months. Patients in arms I or II (of phase II) receive a decision aid after completion of the follow-up survey.
- Conditions
- Breast Cancer
- Being tested
- informational intervention, questionnaire administration, survey administration
- Keywords
- 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.
informational interventionOther
questionnaire administrationOther
survey administrationOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Development and testing of a decision aid that describes the risks and benefits of taking tamoxifen citrate to prevent primary breast cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2009 (estimated)
- Study startOct 2005
- Primary completionAug 2008
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 CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer 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 1/2
- Allocation
- Randomised
- Enrolment
- 1,683 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Angela Fagerlin, PhD, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967824
- Sponsor's protocol ID
- CDR0000649906
- Other IDs
- P50CA101451, P30CA046592, IRBMED-2004-0695
- Status last verified
- Mar 2011
- First submitted
- 27 Aug 2009
- Last updated
- 24 Mar 2011
- Results posted
- No
Publications
Korfage IJ, Fuhrel-Forbis A, Ubel PA, Zikmund-Fisher BJ, Greene SM, McClure JB, Smith DM, Alford SH, Fagerlin A. Informed choice about breast cancer prevention: randomized controlled trial of an online decision aid intervention. Breast Cancer Res. 2013;15(5):R74. doi: 10.1186/bcr3468.
PubMed 24004815Banegas MP, McClure JB, Barlow WE, Ubel PA, Smith DM, Zikmund-Fisher BJ, Greene SM, Fagerlin A. Results from a randomized trial of a web-based, tailored decision aid for women at high risk for breast cancer. Patient Educ Couns. 2013 Jun;91(3):364-71. doi: 10.1016/j.pec.2012.12.014. Epub 2013 Feb 8.
PubMed 23395006
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing a Tamoxifen Prophylaxis Decision Aid
- ClinicalTrials.gov ID
- NCT00967824
- Acronym / sponsor ID
- CDR0000649906
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,683 participants (estimated)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2005
- Primary completion
- Aug 2008 (actual)
- First posted
- 28 Aug 2009 (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.
RATIONALE: Evaluating a decision aid that describes the risks and benefits of taking tamoxifen citrate to prevent breast cancer may be helpful for women at increased risk of breast cancer.
PURPOSE: This randomized phase I/II trial is studying tamoxifen citrate decision aids for women at increased risk of breast cancer.
Detailed description
OBJECTIVES:
- To develop and test a decision aid for describing the risks and benefits of taking tamoxifen citrate to prevent primary breast cancer in women at increased risk of breast cancer.
OUTLINE:
- Phase I: Patients are randomized to view 1 of 16 decision aids that vary in terms of how the information is presented based on 5 dimensions: 1) statistical information in pictographs vs plain text, 2) risk information presented with denominators of 100 vs 1000, 3) risk information presented in terms of total vs additional risk, 4) whether the risks of tamoxifen citrate are presented before or after the benefits are presented, and 5) contextual information about other risks the patient faces (all cause mortality, colon cancer, heart attack).
Patients complete baseline and post-test questionnaires.
- Phase II: Patients are randomized to 1 of 3 arms.
- Arm I (control): Patients do not view the decision aid, but complete baseline and post-test questionnaires.
- Arm II (control): Patients complete a baseline questionnaire only. They do not view the decision aid or complete the post-test questionnaire.
- Arm III (intervention): Patients view 1 of 16 decision aids that vary based on 5 factors: 1) providing (or not) comparative information about the average woman's breast cancer risk, 2) sequencing presentation of risks and benefits (risks first vs benefits first), 3) including (or not) a summary table following presentation of risks and benefits, 4) using second vs third person language ("your risk" vs "a person like you"), and 5) presenting the decision as having 2 vs 3 options (taking/not taking a breast cancer prevention drug vs taking tamoxifen citrate/raloxifene, or no drug). Patients also complete baseline and post-test questionnaires.
Patients in both phases complete an online follow-up survey at 3 months. Patients in arms I or II (of phase II) receive a decision aid after completion of the follow-up survey.
Study design
- Allocation
- Randomised
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| informational intervention | Other | – |
| questionnaire administration | Other | – |
| survey administration | Other | – |
Primary outcome
Development and testing of a decision aid that describes the risks and benefits of taking tamoxifen citrate to prevent primary breast cancer
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 24 Mar 2011.
- Derived from this study: PubMed 24004815Korfage IJ, Fuhrel-Forbis A, Ubel PA, Zikmund-Fisher BJ, Greene SM, McClure JB, Smith DM, Alford SH, Fagerlin A. Informed choice about breast cancer prevention: randomized controlled trial of an online decision aid intervention. Breast Cancer Res. 2013;15(5):R74. doi: 10.1186/bcr3468.
- Derived from this study: PubMed 23395006Banegas MP, McClure JB, Barlow WE, Ubel PA, Smith DM, Zikmund-Fisher BJ, Greene SM, Fagerlin A. Results from a randomized trial of a web-based, tailored decision aid for women at high risk for breast cancer. Patient Educ Couns. 2013 Jun;91(3):364-71. doi: 10.1016/j.pec.2012.12.014. Epub 2013 Feb 8.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Angela Fagerlin, PhD principal investigator
University of Michigan Rogel Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing informational intervention, questionnaire administration and survey administration in people with Breast Cancer, run by University of Michigan Rogel Cancer Center.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Development and testing of a decision aid that describes the risks and benefits of taking tamoxifen citrate to prevent primary breast cancer. 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 NCT00967824, 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 24 Mar 2011.