Breast CancerNCT01399359
Factors Influencing Decision-Making About the Use of Chemoprevention in Women at Increased Risk for Breast Cancer
An observational study of Breast Cancer, run by NSABP Foundation Inc at 1 site in United States.
Trial summary
RATIONALE: Learning about how patients make decisions about using chemoprevention may help doctors plan treatment in which more patients are willing to choose chemoprevention to reduce their breast cancer risk. Read more about this study
- Who is it for?
- Ages 35 to 120 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Counseling session, Questionnaire 1 and Questionnaire 2
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,023 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Oct 2014
- Phase
- Observational
- 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 35 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women at increased risk for breast cancer.
Who may be able to join
- The participant must be female.
- The participant must be greater than or equal to 35 years of age.
- The participant must be English-speaking.
- The participant must have been identified as being at increased risk for breast cancer as determined by the doctor/healthcare professional (HCP) . (Increased risk for breast cancer does not have to be based on a Gail score.)
- During the participant's counseling session, breast cancer risk and the use of SERMs for breast cancer risk reduction must have been discussed, as reported by the doctor/HCP who conducted the session. Note: This criterion does not apply to participants who are asked before the counseling session to participate in the video recording component of DMP-1 at the selected NSABP sites.
Who cannot join
- Previous invasive breast cancer of any type.
- Previous history of ductal carcinoma in situ (DCIS).
- Previous history of lobular carcinoma in situ (LCIS) if treated with mastectomy, radiation therapy, or endocrine therapy.
- Participation in any other cancer prevention study involving pharmacologic intervention(s) or osteoporosis prevention study involving pharmacologic intervention(s).
- Any history of or current tamoxifen, raloxifene, or other SERM therapy for any reason. (Participants are eligible if SERM use has been discussed prior to the counseling session as long as SERMs were never used.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate Different Decision-Making Approaches Used by Women Known to be at Increased Risk for Breast Cancer
RATIONALE: Learning about how patients make decisions about using chemoprevention may help doctors plan treatment in which more patients are willing to choose chemoprevention to reduce their breast cancer risk.
PURPOSE: This clinical trial studies factors influencing decision-making about the use of chemoprevention in women at increased risk for breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- To describe the influence of social, environmental, and psychological factors (sociality of medication intake, life-events, understanding of prevention, clinical situation) on the decision of women at risk for breast cancer as to whether or not to take chemoprevention agents.
Secondary
- To determine the implications of and influences on decision-making that a diagnosis of "being at risk for breast cancer" has for women.
- To determine what factors hinder women from taking chemoprevention for breast cancer.
- To field test a questionnaire that identifies the factors that influence the decision-making process of women at increased risk of breast cancer for whom chemoprevention is a medically indicated option.
- To describe the influence of social, environmental, and psychological factors on the decision of women at risk for breast cancer as to whether or not to take chemoprevention agents by menopausal status.
- For postmenopausal women who decide to take a selective estrogen-receptor modulator (SERM) for breast cancer prevention, to assess reasons for the choice of raloxifene versus tamoxifen.
OUTLINE: This is a multicenter study.
Participants undergo a counseling session about their increased risk for breast cancer and the use of a selective estrogen-receptor modulator (SERM), tamoxifen citrate or raloxifene, to reduce breast cancer risk. Some participants may have their counseling session video-recorded. They are also asked to review the video with their interviewers and to be contacted for a brief follow-up telephone interview.
Participants then complete an initial questionnaire to assess recall and understanding of risk information given to them during the counseling session. This first questionnaire is completed preferably on the same day of counseling before leaving the clinic or office. Participants also have the option to take the questionnaire home and return it to the study site within 2 weeks. Participants who return the first questionnaire complete a second one before leaving the clinic or office, or receive it by mail with a returned self-addressed stamped envelope. Participants who indicate on the second questionnaire that they do not want to take a SERM are asked to complete an online questionnaire. Participants who have not made a decision about SERM use within 3 months after counseling are contacted by telephone. They also receive the second questionnaire by mail 3 months after the telephone contact.
Interviewers, doctors, or other health-care professionals also complete questionnaires that indicate what was discussed during counseling sessions.
- Conditions
- Breast Cancer
- Being tested
- Counseling session, Questionnaire 1, Questionnaire 2, online questionnaire
- 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.
Counseling sessionBehavioural
Questionnaire 1Other
Questionnaire 1 assesses the recall and understanding of risk information given during the counseling session.
Questionnaire 2Other
Questionnaire 2 focuses on what factors, other thana the numerical risk-benefit analysis of SERM intake, are important in the decision-making process of women at increased risk for breast cancer.
online questionnaireOther
| Study group | Role | What they receive |
|---|---|---|
| Women who decide not to take a SERM | Women participate in the counseling session, questionnaire 1, and questionnaire 2, and the online questionnaire. Receives: Behavioral: Counseling session; Other: Questionnaire 1; Other: Questionnaire 2; Other: online questionnaire | |
| Women who decide to take a SERM | Women participate in the counseling session, questionnaire 1 and questionnaire 2. Receives: Behavioral: Counseling session; Other: Questionnaire 1; Other: Questionnaire 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social, environmental, and psychological influences on the decision of women at risk for breast cancer as to whether or not to take a SERM
Measured: Measured at start of study and at 3 to 6 months
Secondary outcomes (5)
Factors hindering women from taking chemoprevention for breast cancer
Measured: Measured at start of study and at 3 to 6 months
Reasons for the choice of raloxifene vs tamoxifen among menopausal women
Measured: Measured at start of study and at 3 to 6 months
The implications of and influences on decision-making that a diagnosis of "being at risk for breast cancer" has for women.
Measured: Measured at start of study and at 3 to 6 months
To test a questionnaire that identifies the factors that influence the decision-making process of women at increased risk of breast cancer for whom chemoprevention is a medically-indicated option.
Measured: Measured at start of study and at 3 to 6 months
To describe the influence of social, environmental, and psychological factors on the decision of women at risk for breast cancer as to whether or not to take chemoprevention agents by menopausal status.
Measured: Measured at start of study and at 3 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2014
- Study completionOct 2014
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,023 participants (actual)
Sponsor and investigators
- Lead sponsor
- NSABP Foundation Inc
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Norman Wolmark, MD, Principal investigator, NSABP Foundation Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399359
- Sponsor's protocol ID
- NSABP-DMP-1
- Other IDs
- NSABP-DMP-1
- Status last verified
- Oct 2021
- First submitted
- 20 Jul 2011
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Blakeslee SB, Gunn CM, Parker PA, Fagerlin A, Battaglia T, Bevers TB, Bandos H, McCaskill-Stevens W, Kennedy JW, Holmberg C. Talking numbers: how women and providers use risk scores during and after risk counseling - a qualitative investigation from the NRG Oncology/NSABP DMP-1 study. BMJ Open. 2023 Nov 19;13(11):e073138. doi: 10.1136/bmjopen-2023-073138.
PubMed 37984961Gunn CM, Bokhour BG, Parker VA, Battaglia TA, Parker PA, Fagerlin A, McCaskill-Stevens W, Bandos H, Blakeslee SB, Holmberg C. Understanding Decision Making about Breast Cancer Prevention in Action: The Intersection of Perceived Risk, Perceived Control, and Social Context: NRG Oncology/NSABP DMP-1. Med Decis Making. 2019 Apr;39(3):217-227. doi: 10.1177/0272989X19827258. Epub 2019 Feb 25.
PubMed 30803311
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Different Decision-Making Approaches Used by Women Known to be at Increased Risk for Breast Cancer
- ClinicalTrials.gov ID
- NCT01399359
- Acronym / sponsor ID
- NSABP-DMP-1
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,023 participants (actual)
- Lead sponsor
- NSABP Foundation IncResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 21 Jul 2011 (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: Learning about how patients make decisions about using chemoprevention may help doctors plan treatment in which more patients are willing to choose chemoprevention to reduce their breast cancer risk.
PURPOSE: This clinical trial studies factors influencing decision-making about the use of chemoprevention in women at increased risk for breast cancer.
Detailed description
OBJECTIVES:
Primary
- To describe the influence of social, environmental, and psychological factors (sociality of medication intake, life-events, understanding of prevention, clinical situation) on the decision of women at risk for breast cancer as to whether or not to take chemoprevention agents.
Secondary
- To determine the implications of and influences on decision-making that a diagnosis of "being at risk for breast cancer" has for women.
- To determine what factors hinder women from taking chemoprevention for breast cancer.
- To field test a questionnaire that identifies the factors that influence the decision-making process of women at increased risk of breast cancer for whom chemoprevention is a medically indicated option.
- To describe the influence of social, environmental, and psychological factors on the decision of women at risk for breast cancer as to whether or not to take chemoprevention agents by menopausal status.
- For postmenopausal women who decide to take a selective estrogen-receptor modulator (SERM) for breast cancer prevention, to assess reasons for the choice of raloxifene versus tamoxifen.
OUTLINE: This is a multicenter study.
Participants undergo a counseling session about their increased risk for breast cancer and the use of a selective estrogen-receptor modulator (SERM), tamoxifen citrate or raloxifene, to reduce breast cancer risk. Some participants may have their counseling session video-recorded. They are also asked to review the video with their interviewers and to be contacted for a brief follow-up telephone interview.
Participants then complete an initial questionnaire to assess recall and understanding of risk information given to them during the counseling session. This first questionnaire is completed preferably on the same day of counseling before leaving the clinic or office. Participants also have the option to take the questionnaire home and return it to the study site within 2 weeks. Participants who return the first questionnaire complete a second one before leaving the clinic or office, or receive it by mail with a returned self-addressed stamped envelope. Participants who indicate on the second questionnaire that they do not want to take a SERM are asked to complete an online questionnaire. Participants who have not made a decision about SERM use within 3 months after counseling are contacted by telephone. They also receive the second questionnaire by mail 3 months after the telephone contact.
Interviewers, doctors, or other health-care professionals also complete questionnaires that indicate what was discussed during counseling sessions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women who decide not to take a SERM | – | Behavioral: Counseling session, Other: Questionnaire 1, Other: Questionnaire 2, Other: online questionnaireWomen participate in the counseling session, questionnaire 1, and questionnaire 2, and the online questionnaire. |
| Women who decide to take a SERM | – | Behavioral: Counseling session, Other: Questionnaire 1, Other: Questionnaire 2Women participate in the counseling session, questionnaire 1 and questionnaire 2. |
Who may qualify
- Ages
- 35 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women at increased risk for breast cancer.
Key inclusion criteria (5 listed)
- The participant must be female.
- The participant must be greater than or equal to 35 years of age.
- The participant must be English-speaking.
- The participant must have been identified as being at increased risk for breast cancer as determined by the doctor/healthcare professional (HCP) . (Increased risk for breast cancer does not have to be based on a Gail score.)
- During the participant's counseling session, breast cancer risk and the use of SERMs for breast cancer risk reduction must have been discussed, as reported by the doctor/HCP who conducted the session. Note: This criterion does not apply to participants who are asked before the counseling session to participate in the video recording component of DMP-1 at the selected NSABP sites.
Key exclusion criteria (5 listed)
- Previous invasive breast cancer of any type.
- Previous history of ductal carcinoma in situ (DCIS).
- Previous history of lobular carcinoma in situ (LCIS) if treated with mastectomy, radiation therapy, or endocrine therapy.
- Participation in any other cancer prevention study involving pharmacologic intervention(s) or osteoporosis prevention study involving pharmacologic intervention(s).
- Any history of or current tamoxifen, raloxifene, or other SERM therapy for any reason. (Participants are eligible if SERM use has been discussed prior to the counseling session as long as SERMs were never used.)
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 |
|---|---|---|
| Counseling session | Behavioural | Women who decide not to take a SERM, Women who decide to take a SERM |
| Questionnaire 1Questionnaire 1 assesses the recall and understanding of risk information given during the counseling session. | Other | Women who decide not to take a SERM, Women who decide to take a SERM |
| Questionnaire 2Questionnaire 2 focuses on what factors, other thana the numerical risk-benefit analysis of SERM intake, are important in the decision-making process of women at increased risk for breast cancer. | Other | Women who decide not to take a SERM, Women who decide to take a SERM |
| online questionnaire | Other | Women who decide not to take a SERM |
Primary outcome
Social, environmental, and psychological influences on the decision of women at risk for breast cancer as to whether or not to take a SERM
Time frame: Measured at start of study and at 3 to 6 months
5 secondary outcomes
Factors hindering women from taking chemoprevention for breast cancer
Time frame: Measured at start of study and at 3 to 6 months
Reasons for the choice of raloxifene vs tamoxifen among menopausal women
Time frame: Measured at start of study and at 3 to 6 months
The implications of and influences on decision-making that a diagnosis of "being at risk for breast cancer" has for women.
Time frame: Measured at start of study and at 3 to 6 months
To test a questionnaire that identifies the factors that influence the decision-making process of women at increased risk of breast cancer for whom chemoprevention is a medically-indicated option.
Time frame: Measured at start of study and at 3 to 6 months
To describe the influence of social, environmental, and psychological factors on the decision of women at risk for breast cancer as to whether or not to take chemoprevention agents by menopausal status.
Time frame: Measured at start of study and at 3 to 6 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 5 Oct 2021.
- Derived from this study: PubMed 37984961Blakeslee SB, Gunn CM, Parker PA, Fagerlin A, Battaglia T, Bevers TB, Bandos H, McCaskill-Stevens W, Kennedy JW, Holmberg C. Talking numbers: how women and providers use risk scores during and after risk counseling - a qualitative investigation from the NRG Oncology/NSABP DMP-1 study. BMJ Open. 2023 Nov 19;13(11):e073138. doi: 10.1136/bmjopen-2023-073138.
- Derived from this study: PubMed 30803311Gunn CM, Bokhour BG, Parker VA, Battaglia TA, Parker PA, Fagerlin A, McCaskill-Stevens W, Bandos H, Blakeslee SB, Holmberg C. Understanding Decision Making about Breast Cancer Prevention in Action: The Intersection of Perceived Risk, Perceived Control, and Social Context: NRG Oncology/NSABP DMP-1. Med Decis Making. 2019 Apr;39(3):217-227. doi: 10.1177/0272989X19827258. Epub 2019 Feb 25.
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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.
Norman Wolmark, MD principal investigator
NSABP Foundation Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by NSABP Foundation Inc 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 5 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 5 Oct 2021. 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?
Social, environmental, and psychological influences on the decision of women at risk for breast cancer as to whether or not to take a SERM (time frame: Measured at start of study and at 3 to 6 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 NCT01399359, 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 5 Oct 2021.