Breast Cancer ScreeningNCT02198690
Trial of a Mammography Decision Aid for Women Aged 75 and Older
A study testing Mammography decision aid and Home safety pamphlet in people with Breast Cancer Screening, run by Beth Israel Deaconess Medical Center at 4 sites in United States.
Trial summary
The aim of this study is to test whether an educational pamphlet on mammography designed for women aged 75 and older improves older women's decision-making around mammography screening. Read more about this study
- Who is it for?
- Ages 75 to 89 years, women only
- Conditions the study is for
- Breast Cancer Screening
- What is being tested?
- Mammography decision aid and Home safety pamphlet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 541 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2014to 1 Apr 2020
- 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 75 to 89 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- English-speaking women
- Aged 75 to 89 years
- Scheduled for a routine visit or physical with their PCP in the next 4-12 weeks
- Women who have not had a mammogram in 6 months but have had one in 2 years.
Who cannot join
- Women who have it documented in their screening sheet that they have chosen to stop screening
- Women with a history of atypical ductal hyperplasia (ADH) or non-invasive or invasive breast cancer
- Women with dementia (on problem list/reported by PCP).
- Women without capacity for informed consent.
- Women that report <7th grade education (the reading level of study materials)
- Patients from PCPs that participated in the pilot or are study investigators.
- Women whose PCPs already had 25 patients participate in the study (the cap per PCP)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Affiliated Physicians Group
Boston, Massachusetts, 02215
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Harvard Vanguard Medical Associates
Boston, Massachusetts, 02215
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27514
About this study
Official title: Randomized Trial of a Mammography Decision Aid for Women Aged 75 and Older
The aim of this study is to test whether an educational pamphlet on mammography designed for women aged 75 and older improves older women's decision-making around mammography screening. The investigators aim to show that the educational pamphlet improves older women's knowledge of the pros and cons or screening and leads to fewer women in poor health with short life expectancy being screened.
Read the detailed description
Women aged 75 and older are the fastest growing segment of the US population and breast cancer incidence increases with age. However, none of the randomized trials of mammography screening included women >74 years and it is not known if mammography helps these women live longer. Increasingly, data suggest that women need around 10 year life expectancy to have a chance at a mortality benefit from being screened with mammography. Meanwhile, there are immediate harms to screening older women including: pain, anxiety, complications from tests after a false positive mammogram (e.g., breast biopsy), and overdiagnosis (finding tumors that otherwise would never have caused symptoms in one's lifetime). Overdiagnosis is particularly concerning since some older women experience significant complications from breast cancer treatment. Guidelines state that there is insufficient evidence to recommend mammography screening for women aged 75 years or older and encourage clinicians to discuss the uncertainty about the balance of benefits and harms with older women. Yet, few older women are informed of potential harms of mammography before being screened, likely because explaining such uncertainty can be challenging and time consuming.
To improve older women's understanding of the benefits and risks of mammography screening, investigators previously developed and pilot tested a pamphlet decision aid (DA) on mammography screening for women aged 75+ years. The pilot pretest/posttest trial of 45 women 75+ years found that the DA resulted in older women being more knowledgeable about the benefits and risks of mammography, clearer in their values, and fewer intended to be screened, especially those with <10 year life expectancy.
Investigators now propose a large cluster randomized controlled trial (RCT) of the DA, using primary care physician (PCP) as the unit of randomization, to definitively evaluate the DA's efficacy. The investigators aim to recruit 550 women 75-89 years from 100 PCPs who provide care at an academic primary care or geriatrics practice in Boston, three community practices in the Boston metro area, or at an academic internal medicine or family practice in North Carolina. Patient participants will either receive the DA (intervention arm) or an educational pamphlet on home safety for older adults (control arm). The investigators chose to use PCPs as the unit of randomization rather than individual patients because they anticipate that some patients will share the DA with their PCPs. Once PCPs are exposed to the DA for one patient they could change their approach to screening which could lead to contamination of the control group making it more difficult to show an effect of the DA.
Aims:
The investigators will examine and evaluate the impact of providing information on benefits and risks of mammography screening to women aged 75 and older on:
- receipt of screening;
- intentions of being screened;
- knowledge of the pros and cons of being screened;
- decisional conflict around screening;
- preferred decision-making role around mammography (active vs. passive/shared with physician);
- documented discussions by PCPs of the risks and benefits of mammography screening in participants' notes.
- Conditions
- Breast Cancer Screening
- Being tested
- Mammography decision aid, Home safety pamphlet
- Keywords
- Mammography, Older women, decision making
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mammography decision aidOther
Home safety pamphletOther
| Study group | Role | What they receive |
|---|---|---|
| Mammography Decision Aid | Experimental | Development and pilot testing of the decision aid (DA) has been described previously. In brief, the DA is written at a 6th grade reading level and includes information on 1) breast cancer risk factors for women >75 years; 2) health/life expectancy; 3) likely outcomes if screened and not screened with mammography; 4) competing mortality risks; 5) breast cancer treatments; and 6) a values clarification exercise. The last page asks users their intentions of being screened on a 15-point validated scale and invites users to share this information with their clinician. PCPs whose patients are randomized to receive the DA will be sent a copy of the DA via email and a link to an optional training on using the DA (5 informational slides and a 3-minute video). Receives: Other: Mammography decision aid |
| Home safety pamphlet | Placebo comparator | To reduce response bias and to compensate for the time and attention required by the intervention group to read the DA, patients in the control arm will be provided a two page pamphlet on home safety for older adults developed by the American Geriatrics Society (AGS) Foundation for Health in Aging. PCPs whose patients are randomized to the receive the home safety pamphlet, will be sent an email informing them that their patient will be coming in early to read health educational materials for older adults as part of a study. We otherwise do not plan any intervention for control group PCPs because we do not want to change their usual behavior. However, if PCPs in the control arm request a copy of the educational materials then we will email them a copy of the home safety pamphlet. Receives: Other: Home safety pamphlet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of mammography screening
The investigators chose receipt of screening as the primary outcome since they anticipate that implementation of the DA will require that the DA impacts mammography use, especially for women with short life expectancy. The investigators will follow women for 15 months to guarantee at least two years of data since their last mammogram (the upper bound of the recommended screening interval). Research staff will review primary care notes, radiology records, and screening sheets (mammograms performed outside the medical system are manually entered on screening sheets). Research staff will contact patients or an alternate if follow-up is not complete in the medical records.
Measured: 18 months
Secondary outcomes (10)
Screening intentions
The investigators will use a validated 15-point scale to assess one's propensity to being screened. The investigators will categorize scores as 1-5 (yes), 6-10 (unsure), or 11-15 (no). The investigators will compare participants who respond with yes vs. those who are unsure or plan not to be screened.
Measured: follow-up interview within 1 week
Knowledge of the pros and cons of mammography screening
11 questions (2 multiple choice and 9 true/false); 7 were adapted from other studies and 4 were developed based on the material in the decision aid. Correct answers will be summed.
Measured: follow-up interview within 1 week
Decisional Conflict Scale (DCS)
The DCS is a validated 16 item scale to measure uncertainty around a decision, whether one feels informed, clear about their personal values, and supported in their decision-making (Cronbach's alpha=0.78 to 0.92);scores range 0-100 and lower scores indicate less conflict.
Measured: Follow-up interview within 1 week
Decision-making role
The Control Preferences Scale (CPS) is commonly used to assess patients' preferred involvement in decision-making. Research staff will categorize responses as active (patient made the final decision) versus passive too or shared with doctor.
Measured: Follow-up interview within 1 week
Preparation for Decision-Making
The investigators will ask women in the intervention arm (DA group) this validated 10 item index to see if the DA prepared them to communicate with their clinician (Cronbach's alpha=0.92-0.96). For the control arm, the investigators will modify this index to ask participants how the pamphlet affects their thoughts around home safety.
Measured: Follow-up interview within 1 week
Acceptability
The investigators will ask about length, clarity, and whether women found the materials anxiety invoking and/or whether they would recommend them to a friend. For the DA only, the investigators will ask if the material is balanced.
Measured: Follow-up interview within 1 week
Anxiety
The investigators will examine whether the educational materials invoke anxiety using the short form of Spielberger State-Trait Anxiety Inventory.
Measured: Follow-up interview within 1 week
Home safety
The investigators will ask both groups their intentions to perform several home safety measures (e.g., check hot water setting) to keep participants blinded to whether they were randomized to the intervention of interest.
Measured: Follow-up interview within 1 week
Screening discussions
Research staff will review PCP notes up to 18 months after participation (in case patients choose to bring up screening at the next visit rather than the index visit) to see if PCPs documented a discussion on mammography. The investigators will categorize a woman as having received a balanced screening discussion if a note includes either: a) discussion of a limitation of screening or b) that mammography was discussed AND whether or not the patient chose to continue screening. To ensure the validity of coding of whether screening discussions occurred, at least 3 investigators will read the de-identified paragraphs of participants' records and code whether they think a balanced discussion occurred. Discrepancies will be adjudicated by consensus between investigators.
Measured: 18 months
Home safety discussions
Research staff will review PCP notes up to 18 months after participation (in case patients choose to bring up screening at the next visit rather than the index visit) to see if PCPs documented a discussion on home safety (e.g., fall prevention tips). The investigators plan to assess both screening and home safety to keep chart abstractors blinded to the outcome of interest. To ensure the validity of coding of whether home safety discussions occurred, at least 3 investigators will read the de-identified paragraphs of participants' records and code whether they think a discussion occurred. Discrepancies will be adjudicated by consensus between investigators.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startSep 2014
- Primary completion1 Aug 2019
- Study completion1 Apr 2020
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 Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 541 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Mara Schonberg, Beth Israel Deaconess Medical Center
- Investigators
- Mara A Schonberg, MD, MPH, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198690
- Sponsor's protocol ID
- 2014P000108
- Other IDs
- R01CA181357
- Status last verified
- Nov 2023
- First submitted
- 16 Jul 2014
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Schonberg MA, Kistler CE, Pinheiro A, Jacobson AR, Aliberti GM, Karamourtopoulos M, Hayes M, Neville BA, Lewis CL, Wee CC, Fagerlin A, Nekhlyudov L, Marcantonio ER, Hamel MB, Davis RB. Effect of a Mammography Screening Decision Aid for Women 75 Years and Older: A Cluster Randomized Clinical Trial. JAMA Intern Med. 2020 Jun 1;180(6):831-842. doi: 10.1001/jamainternmed.2020.0440.
PubMed 32310288
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of a Mammography Decision Aid for Women Aged 75 and Older
- ClinicalTrials.gov ID
- NCT02198690
- Acronym / sponsor ID
- 2014P000108
- Conditions
- Breast Cancer Screening
- Keywords
- Mammography, Older women, decision making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 541 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2014 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 24 Jul 2014 (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 aim of this study is to test whether an educational pamphlet on mammography designed for women aged 75 and older improves older women's decision-making around mammography screening. The investigators aim to show that the educational pamphlet improves older women's knowledge of the pros and cons or screening and leads to fewer women in poor health with short life expectancy being screened.
Detailed description
Women aged 75 and older are the fastest growing segment of the US population and breast cancer incidence increases with age. However, none of the randomized trials of mammography screening included women >74 years and it is not known if mammography helps these women live longer. Increasingly, data suggest that women need around 10 year life expectancy to have a chance at a mortality benefit from being screened with mammography. Meanwhile, there are immediate harms to screening older women including: pain, anxiety, complications from tests after a false positive mammogram (e.g., breast biopsy), and overdiagnosis (finding tumors that otherwise would never have caused symptoms in one's lifetime). Overdiagnosis is particularly concerning since some older women experience significant complications from breast cancer treatment. Guidelines state that there is insufficient evidence to recommend mammography screening for women aged 75 years or older and encourage clinicians to discuss the uncertainty about the balance of benefits and harms with older women. Yet, few older women are informed of potential harms of mammography before being screened, likely because explaining such uncertainty can be challenging and time consuming.
To improve older women's understanding of the benefits and risks of mammography screening, investigators previously developed and pilot tested a pamphlet decision aid (DA) on mammography screening for women aged 75+ years. The pilot pretest/posttest trial of 45 women 75+ years found that the DA resulted in older women being more knowledgeable about the benefits and risks of mammography, clearer in their values, and fewer intended to be screened, especially those with <10 year life expectancy.
Investigators now propose a large cluster randomized controlled trial (RCT) of the DA, using primary care physician (PCP) as the unit of randomization, to definitively evaluate the DA's efficacy. The investigators aim to recruit 550 women 75-89 years from 100 PCPs who provide care at an academic primary care or geriatrics practice in Boston, three community practices in the Boston metro area, or at an academic internal medicine or family practice in North Carolina. Patient participants will either receive the DA (intervention arm) or an educational pamphlet on home safety for older adults (control arm). The investigators chose to use PCPs as the unit of randomization rather than individual patients because they anticipate that some patients will share the DA with their PCPs. Once PCPs are exposed to the DA for one patient they could change their approach to screening which could lead to contamination of the control group making it more difficult to show an effect of the DA.
Aims:
The investigators will examine and evaluate the impact of providing information on benefits and risks of mammography screening to women aged 75 and older on:
- receipt of screening;
- intentions of being screened;
- knowledge of the pros and cons of being screened;
- decisional conflict around screening;
- preferred decision-making role around mammography (active vs. passive/shared with physician);
- documented discussions by PCPs of the risks and benefits of mammography screening in participants' notes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mammography Decision Aid | Experimental | Other: Mammography decision aidDevelopment and pilot testing of the decision aid (DA) has been described previously. In brief, the DA is written at a 6th grade reading level and includes information on 1) breast cancer risk factors for women >75 years; 2) health/life expectancy; 3) likely outcomes if screened and not screened with mammography; 4) competing mortality risks; 5) breast cancer treatments; and 6) a values clarification exercise. The last page asks users their intentions of being screened on a 15-point validated scale and invites users to share this information with their clinician. PCPs whose patients are randomized to receive the DA will be sent a copy of the DA via email and a link to an optional training on using the DA (5 informational slides and a 3-minute video). |
| Home safety pamphlet | Placebo comparator | Other: Home safety pamphletTo reduce response bias and to compensate for the time and attention required by the intervention group to read the DA, patients in the control arm will be provided a two page pamphlet on home safety for older adults developed by the American Geriatrics Society (AGS) Foundation for Health in Aging. PCPs whose patients are randomized to the receive the home safety pamphlet, will be sent an email informing them that their patient will be coming in early to read health educational materials for older adults as part of a study. We otherwise do not plan any intervention for control group PCPs because we do not want to change their usual behavior. However, if PCPs in the control arm request a copy of the educational materials then we will email them a copy of the home safety pamphlet. |
Who may qualify
- Ages
- 75 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- English-speaking women
- Aged 75 to 89 years
- Scheduled for a routine visit or physical with their PCP in the next 4-12 weeks
- Women who have not had a mammogram in 6 months but have had one in 2 years.
Key exclusion criteria (7 listed)
- Women who have it documented in their screening sheet that they have chosen to stop screening
- Women with a history of atypical ductal hyperplasia (ADH) or non-invasive or invasive breast cancer
- Women with dementia (on problem list/reported by PCP).
- Women without capacity for informed consent.
- Women that report <7th grade education (the reading level of study materials)
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 |
|---|---|---|
| Mammography decision aid | Other | Mammography Decision Aid |
| Home safety pamphlet | Other | Home safety pamphlet |
Primary outcome
Receipt of mammography screening
Time frame: 18 months
The investigators chose receipt of screening as the primary outcome since they anticipate that implementation of the DA will require that the DA impacts mammography use, especially for women with short life expectancy. The investigators will follow women for 15 months to guarantee at least two years of data since their last mammogram (the upper bound of the recommended screening interval). Research staff will review primary care notes, radiology records, and screening sheets (mammograms performed outside the medical system are manually entered on screening sheets). Research staff will contact patients or an alternate if follow-up is not complete in the medical records.
10 secondary outcomes
Screening intentions
Time frame: follow-up interview within 1 week
Knowledge of the pros and cons of mammography screening
Time frame: follow-up interview within 1 week
Decisional Conflict Scale (DCS)
Time frame: Follow-up interview within 1 week
Decision-making role
Time frame: Follow-up interview within 1 week
Preparation for Decision-Making
Time frame: Follow-up interview within 1 week
Acceptability
Time frame: Follow-up interview within 1 week
Anxiety
Time frame: Follow-up interview within 1 week
Home safety
Time frame: Follow-up interview within 1 week
Screening discussions
Time frame: 18 months
Home safety discussions
Time frame: 18 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 14 Nov 2023.
- Derived from this study: PubMed 32310288Schonberg MA, Kistler CE, Pinheiro A, Jacobson AR, Aliberti GM, Karamourtopoulos M, Hayes M, Neville BA, Lewis CL, Wee CC, Fagerlin A, Nekhlyudov L, Marcantonio ER, Hamel MB, Davis RB. Effect of a Mammography Screening Decision Aid for Women 75 Years and Older: A Cluster Randomized Clinical Trial. JAMA Intern Med. 2020 Jun 1;180(6):831-842. doi: 10.1001/jamainternmed.2020.0440.
- Individual participant dataSharing planned: No
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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.
Mara A Schonberg, MD, MPH principal investigator
Beth Israel Deaconess Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mammography decision aid and Home safety pamphlet in people with Breast Cancer Screening, run by Beth Israel Deaconess Medical Center at 4 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 7 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 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. Some participants in this study may receive a placebo. 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?
Receipt of mammography screening (time frame: 18 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 NCT02198690, 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 14 Nov 2023.