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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG089237-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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This study evaluates the effectiveness of a Shared Decision-Making (SDM) toolkit designed to support older breast cancer survivors aged 80 and above in making informed decisions about continuing surveillance mammography.
This study evaluates the effectiveness of a Shared Decision-Making (SDM) toolkit designed to support older breast cancer survivors aged 80 and above in making informed decisions about continuing surveillance mammography.
A participant will be placed into one of two groups: Group A: Usual Care vs. Group B: SDM Toolkit according to the randomized placement of the assigned study clinician.
Study procedures include questionnaires and option interviews with study staff.
Participation in this research study is expected to last about 2 years.
It is expected about 52 clinicians and 312 participants will take part in this research study.
The National Institute on Aging is providing funding for this research study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shared-Decision Making Toolkit | Experimental | Enrolled participants will complete:
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| Usual Care | No Intervention | Enrolled participants will continue with standard care practices without the SDM toolkit and will complete:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shared Decision-Making Toolkit | Behavioral | The SDM toolkit is designed to support discussions on the continuation of surveillance mammography. It provides evidence-based guidelines, communication strategies, and education materials to aid in personalized decision-making. |
| Measure | Description | Time Frame |
|---|---|---|
| Mammography Rate | Mammography Rate is defined as the proportion of participants that undergo mammography by 2 years post-enrollment. | Assessed at 2 years post-enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Mammography Count | Mammography Count is defined as the count of all mammograms each participant underwent during study follow-up. | Assessed at 2 years post-enrollment. |
| Participant Knowledge Score |
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Participant Inclusion Criteria:
Women aged ≥ 80 years at the time of registration
History of stage 0-III breast cancer (Of note: ductal carcinoma in situ [DCIS], pleomorphic lobular carcinoma in situ [because it is typically treated like DCIS], or invasive breast cancer of any subtype are all eligible)
No history of a recurrent breast cancer (i.e., a breast cancer that is deemed metastatic or a locoregional recurrence of a prior cancer per clinician judgement rather than a new primary breast cancer). If a person has been diagnosed with multiple distinct breast cancers over time (e.g., history of left and right breast cancer), they are eligible as long as they meet other requirements for time since surgery, etc.
Has at least one intact breast
Has had mammogram screening/surveillance within the last 24 months
-≥ 12 months since most recent breast surgery to affected breast (e.g., breast reduction surgery on an unaffected breast within 12 months is ok)
No active cancer-directed therapy other than hormonal therapy and/or CDK 4/6 inhibitor therapy
Ability and willingness to take surveys
Receiving at least some of their oncology follow-up care at a participating site
Most recent mammogram report for the potential participant did not recommend additional diagnostic work-up or close interval follow-up imaging
Participant Exclusion Criteria:
Clinician Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Freedman, MD, MPH | Contact | 617-632-4587 | Rachel_freedman@dfci.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rachel Freedman, MD, MPH | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02115 | United States |
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
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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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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Randomized at the clinician level in a 1:1 fashion, stratified by site
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randomized to having educational material or not.
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Participant Knowledge Score will be defined as the proportion of correct knowledge questions (range: 0 to 1).
| Annually through 2 years of follow-up post-enrollment. |
| Participant Decisional Quality Score | Participant Decisional Quality Score will be defined as the sum of response scores (range of 0-4), with each individual response scored 0 or 1. Higher scores indicate higher decisional quality. | Annually through 2 years of follow-up post-enrollment. |
| D017437 |
| Skin and Connective Tissue Diseases |