Breast CancerNCT03865654
Individualizing Surveillance Mammography for Older Breast Cancer Survivors
A study testing Communication Tool in people with Breast Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
This research is being conducted to develop consensus on surveillance mammography and follow-up for breast cancer survivors who are age ≥75. Read more about this study
- Who is it for?
- Ages 75 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Communication Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2019to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Female gender, given that screening guidelines do not exist for men
- Receiving part or all of their care at DFCI
- Ages 75-79 (approximately 15 patients)
- Age ≥80 (approximately 15 patients)
- History of stage 0-II breast cancer
- -≥1 Charlson comorbidity present72, defined as one of the following:
Show all 50Show fewer
- Diabetes
- Liver disease
- History of or other active malignancy other than non-melanoma skin cancers
- HIV or AIDS
- Chronic kidney disease
- History of myocardial infarction and/or congestive heart failure
- Chronic lung disease (emphysema/chronic bronchitis/chronic obstructive pulmonary disease [COPD], interstitial lung disease)
- Peripheral vascular disease
- Cerebrovascular disease (history of TIA or stroke)
- Dementia
- Hemiplegia/paralysis
- Connective tissue disorder
- Underwent breast conserving surgery for treatment of this cancer
- Completed all active breast cancer therapy >3 months prior to enrollment (i.e. any chemotherapy, trastuzumab, radiation). Ongoing hormonal therapy or enrollment in survivorship clinical trials (aspirin, exercise, etc) is allowed.
- English-speaking and reading (for this initial work)
- Aim 1.1. Cognitive testing of the communication tool. The criteria for this are intentionally more flexible than in other aims, as we are simply working to initially test the tool and its readability and understandability. Patients will be eligible to cognitively test the tool if they meet the following criteria:
- Female gender
- Previous diagnosis of breast cancer
- Age ≥75
- Receive some/all care at Dana-Farber Cancer Institute
- English speaking-reading
- Aim 1.2. Pilot testing the communication tool in clinic.
- Previous diagnosis of stage 0-II breast cancer
- Receive some/all care at Dana-Farber Cancer Institute (main campus or St. Elizabeth's site)
- Completed any active breast cancer therapy > 3 months prior to enrollment (i.e. any chemotherapy, trastuzumab, radiation). Ongoing hormonal therapy or enrollment in survivorship clinical trials (aspirin, exercise, etc) is allowed.
- Age ≥75
- Had breast-conserving surgery to treat this cancer
- -≥1 the following comorbid conditions72 present, defined as the following:
- Diabetes
- Liver disease
- History of or other active malignancy other than non-melanoma skin cancers
- HIV or AIDS
- Chronic kidney disease
- History of myocardial infarction and/or congestive heart failure
- Chronic lung disease (COPD, interstitial lung disease)
- Peripheral vascular disease
- Cerebrovascular disease (history of TIA or stroke)
- Dementia
- Hemiplegia/paralysis
- Connective tissue disorder
- Provider does not opt out of the patient's enrollment via email notification
- Blessed Orientation Memory Concentration (COMC) score is <10 and capacity is met73 (see Appendix A for BOMC scale)
- Providers of participating patients will be sent a one-time survey but there are no other eligibility for providers to participate in this other than their patient participated
- English speaking and reading
Who cannot join
- Are unable to consent
- Who do not read and write English (for this initial pilot)
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
This research is being conducted to develop consensus on surveillance mammography and follow-up for breast cancer survivors who are age ≥75.
Read the detailed description
The investigators will develop a communication tool that summarizes recommendations for clinicians and patients for surveillance mammography and follow-up care for breast cancer survivors age ≥75. Developing expert-panel recommendations, examining clinician and patient attitudes towards these recommendations, and testing a strategy for communication of expert recommendations on mammography cessation through direct engagement of specialists, primary care clinicians (PCs), and patients.
This is a multi-step study, the investigators will build on prior steps to develop consensus on surveillance mammography and follow-ups for breast cancer survivors who are age >= 75.
This study includes a physician focus group.
- Conditions
- Breast Cancer
- Being tested
- Communication Tool
- 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.
Communication ToolOther
Summarizes recommendations for clinicians and patients for surveillance mammography and follow-up care for breast cancer survivors
| Study group | Role | What they receive |
|---|---|---|
| Surveillance Mammography Communication Tool | Experimental | * Conduct 30 telephone-based patient interviews
* 4-6 focus groups with oncologists and primary care providers (PCs) to learn their perceptions and thoughts about when to stop surveillance mammography
* Perform cognitive testing of the communication tool Receives: Other: Communication Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Change in Intentions for Mammography in the Next Year
Survey measure on whether mammography will be done or not
Measured: 2 years
Secondary outcomes (2)
Rate of Satisfaction
Survey asking about satisfaction with the tool
Measured: 2 years
Preferred Decision-making Role
Survey on preferred decision-making style
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start16 May 2019
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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 Dana-Farber Cancer InstituteThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Rachel Freedman, MD, MPH, Dana-Farber Cancer Institute
- Investigators
- Rachel Freedman, MD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865654
- Sponsor's protocol ID
- 19-001
- Other IDs
- 1R21CA227615-01A1
- Status last verified
- Aug 2022
- First submitted
- 5 Mar 2019
- Last updated
- 24 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Publications
Freedman RA, Revette AC, Gagnon H, Perilla-Glen A, Kokoski M, Hussein SO, Leone E, Hixon N, Lovato R, Loeser W, Lin NU, Minami CA, Canin B, LeStage B, Faggen M, Poorvu PD, McKenna J, Ruddy KJ, Keating NL, Schonberg MA. Acceptability of a companion patient guide to support expert consensus guidelines on surveillance mammography in older breast cancer survivors. Breast Cancer Res Treat. 2022 Sep;195(2):141-152. doi: 10.1007/s10549-022-06676-3. Epub 2022 Jul 30.
PubMed 35908120
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualizing Surveillance Mammography for Older Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT03865654
- Acronym / sponsor ID
- 19-001
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 16 May 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 7 Mar 2019 (actual)
- Results
- Posted 24 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is being conducted to develop consensus on surveillance mammography and follow-up for breast cancer survivors who are age ≥75.
Detailed description
The investigators will develop a communication tool that summarizes recommendations for clinicians and patients for surveillance mammography and follow-up care for breast cancer survivors age ≥75. Developing expert-panel recommendations, examining clinician and patient attitudes towards these recommendations, and testing a strategy for communication of expert recommendations on mammography cessation through direct engagement of specialists, primary care clinicians (PCs), and patients.
This is a multi-step study, the investigators will build on prior steps to develop consensus on surveillance mammography and follow-ups for breast cancer survivors who are age >= 75.
This study includes a physician focus group.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surveillance Mammography Communication Tool | Experimental | Other: Communication Tool* Conduct 30 telephone-based patient interviews * 4-6 focus groups with oncologists and primary care providers (PCs) to learn their perceptions and thoughts about when to stop surveillance mammography * Perform cognitive testing of the communication tool |
Who may qualify
- Ages
- 75 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (50 listed)
- Female gender, given that screening guidelines do not exist for men
- Receiving part or all of their care at DFCI
- Ages 75-79 (approximately 15 patients)
- Age ≥80 (approximately 15 patients)
- History of stage 0-II breast cancer
Key exclusion criteria (2 listed)
- Are unable to consent
- Who do not read and write English (for this initial pilot)
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 |
|---|---|---|
| Communication ToolSummarizes recommendations for clinicians and patients for surveillance mammography and follow-up care for breast cancer survivors | Other | Surveillance Mammography Communication Tool |
Primary outcome
Rate of Change in Intentions for Mammography in the Next Year
Time frame: 2 years
Survey measure on whether mammography will be done or not
2 secondary outcomes
Rate of Satisfaction
Time frame: 2 years
Preferred Decision-making Role
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35908120Freedman RA, Revette AC, Gagnon H, Perilla-Glen A, Kokoski M, Hussein SO, Leone E, Hixon N, Lovato R, Loeser W, Lin NU, Minami CA, Canin B, LeStage B, Faggen M, Poorvu PD, McKenna J, Ruddy KJ, Keating NL, Schonberg MA. Acceptability of a companion patient guide to support expert consensus guidelines on surveillance mammography in older breast cancer survivors. Breast Cancer Res Treat. 2022 Sep;195(2):141-152. doi: 10.1007/s10549-022-06676-3. Epub 2022 Jul 30.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
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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.
Rachel Freedman, MD, MPH principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication Tool in people with Breast Cancer, run by Dana-Farber Cancer Institute 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 50 inclusion and 2 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 24 Aug 2022. 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?
Yes. Results are posted in the registry (first posted 24 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rate of Change in Intentions for Mammography in the Next Year (time frame: 2 years). 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 NCT03865654, 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 24 Aug 2022.