Individualizing Surveillance Mammography for Older Breast Cancer Survivors

• ClinicalTrials.gov Identifier: NCT03865654
• Recruitment Status: Completed
• First Posted: March 7, 2019
• Results First Posted: August 24, 2022
• Last Update Posted: August 24, 2022
• Sponsor: Dana-Farber Cancer Institute
• Collaborators: National Institutes of Health (NIH); National Cancer Institute (NCI)
• Information provided by (Responsible Party): Rachel Freedman, MD, MPH, Dana-Farber Cancer Institute

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research
• Condition: Breast Cancer
• Intervention: Other: Communication Tool
• Enrollment: 45

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Surveillance Mammography Communication Tool
Arm/Group Description	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 Communication Tool: Summarizes recommendations for clinicians and patients for surveillance mammography and follow-up care for breast cancer survivors
Period Title: Overall Study
Started	45
Completed	40
Not Completed	5

Baseline Characteristics

Arm/Group Title		Surveillance Mammography Communication Tool
Arm/Group Description		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 Communication Tool: Summarizes recommendations for clinicians and patients for surveillance mammography and follow-up care for breast cancer survivors
Overall Number of Baseline Participants		45
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	45 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	0 0.0%
	>=65 years	45 100.0%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	45 participants
	Female	45 100.0%
	Male	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	45 participants
	American Indian or Alaska Native	0 0.0%
	Asian	1 2.2%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	1 2.2%
	White	43 95.6%
	More than one race	0 0.0%
	Unknown or Not Reported	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	45 participants
		45

Outcome Measures

1. Primary Outcome

Title	Rate of Change in Intentions for Mammography in the Next Year
Description	Survey measure on whether mammography will be done or not
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Surveillance Mammography Communication Tool
Arm/Group Description:	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 Communication Tool: Summarizes recommendations for clinicians and patients for surveillance mammography and follow-up care for breast cancer survivors
Overall Number of Participants Analyzed	40
Measure Type: Count of Participants; Unit of Measure: Participants
Intention to undergo mammogram	39 97.5%
Intention to not undergo mammogram	1 2.5%

2. Secondary Outcome

Title	Rate of Satisfaction
Description	Survey asking about satisfaction with the tool
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Surveillance Mammography Communication Tool
Arm/Group Description:	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 Communication Tool: Summarizes recommendations for clinicians and patients for surveillance mammography and follow-up care for breast cancer survivors
Overall Number of Participants Analyzed	40
Measure Type: Count of Participants; Unit of Measure: Participants
Tool was very, somewhat, or a little helpful	31 77.5%
Tool was not help	6 15.0%
Did not respond	3 7.5%

3. Secondary Outcome

Title	Preferred Decision-making Role
Description	Survey on preferred decision-making style
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Surveillance Mammography Communication Tool
Arm/Group Description:	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 Communication Tool: Summarizes recommendations for clinicians and patients for surveillance mammography and follow-up care for breast cancer survivors
Overall Number of Participants Analyzed	45
Measure Type: Count of Participants; Unit of Measure: Participants
I prefer to make the final decision.	14 31.1%
I prefer to make the final decision after seriously considering my health care provider's opinion.	15 33.3%
I prefer that my health care provider and I share responsibility for deciding .	13 28.9%
I prefer that my health care provider makes the final decision, but seriously considers my opinion.	3 6.7%

Adverse Events

Time Frame	Not applicable- no adverse events for this survey-based study
Adverse Event Reporting Description	Not applicable, no adverse events for this survey-based study
Arm/Group Title	Surveillance Mammography Communication Tool
Arm/Group Description	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 Communication Tool: Summarizes recommendations for clinicians and patients for surveillance mammography and follow-up care for breast cancer survivors
All-Cause Mortality
	Surveillance Mammography Communication Tool
	Affected / at Risk (%)
Total	0/0
Serious Adverse Events
	Surveillance Mammography Communication Tool
	Affected / at Risk (%)
Total	0/0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Surveillance Mammography Communication Tool
	Affected / at Risk (%)
Total	0/0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Rachel Freedman, M.D., M.P.H.
• Organization: Dana-Farber Cancer Institute
• Phone: 617-632-3800
• EMail: rafreedman@partners.org

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Rachel Freedman, MD, MPH, Dana-Farber Cancer Institute
• ClinicalTrials.gov Identifier: NCT03865654
• Other Study ID Numbers: 19-001; 1R21CA227615-01A1 ( U.S. NIH Grant/Contract )
• First Submitted: March 5, 2019
• First Posted: March 7, 2019
• Results First Submitted: June 21, 2022
• Results First Posted: August 24, 2022
• Last Update Posted: August 24, 2022