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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21CA227615-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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This research is being conducted to develop consensus on surveillance mammography and follow-up for breast cancer survivors who are age ≥75.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surveillance Mammography Communication Tool | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Communication Tool | Other | Summarizes recommendations for clinicians and patients for surveillance mammography and follow-up care for breast cancer survivors |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Change in Intentions for Mammography in the Next Year | Survey measure on whether mammography will be done or not | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Satisfaction | Survey asking about satisfaction with the tool | 2 years |
| Preferred Decision-making Role | Survey on preferred decision-making style |
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Inclusion Criteria:
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:
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:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Freedman, MD, MPH | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35908120 | Derived | 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. |
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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
Data can be shared no earlier than 1 year following the date of publication.
BCH - Contact the Technology & Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation
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| ID | Title | Description |
|---|---|---|
| FG000 | Surveillance Mammography Communication Tool |
Communication Tool: Summarizes recommendations for clinicians and patients for surveillance mammography and follow-up care for breast cancer survivors |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Surveillance Mammography Communication Tool |
Communication Tool: Summarizes recommendations for clinicians and patients for surveillance mammography and follow-up care for breast cancer survivors |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Change in Intentions for Mammography in the Next Year | Survey measure on whether mammography will be done or not | Posted | Count of Participants | Participants | 2 years |
|
|
Not applicable- no adverse events for this survey-based study
Not applicable, no adverse events for this survey-based study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Surveillance Mammography Communication Tool |
Communication Tool: Summarizes recommendations for clinicians and patients for surveillance mammography and follow-up care for breast cancer survivors |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel Freedman, M.D., M.P.H. | Dana-Farber Cancer Institute | 617-632-3800 | rafreedman@partners.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 1, 2020 | Jun 21, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 1, 2020 | Jun 21, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 2 years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Secondary | Rate of Satisfaction | Survey asking about satisfaction with the tool | Posted | Count of Participants | Participants | 2 years |
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| Secondary | Preferred Decision-making Role | Survey on preferred decision-making style | Posted | Count of Participants | Participants | 2 years |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| I prefer that my health care provider makes the final decision, but seriously considers my opinion. |
|