Trial Outcomes & Findings for Individualizing Surveillance Mammography for Older Breast Cancer Survivors (NCT NCT03865654)

NCT ID: NCT03865654

Last Updated: 2022-08-24

Results Overview

Survey measure on whether mammography will be done or not

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 45 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2022-08-24

Participant Flow

Participant milestones

Measure	Surveillance Mammography 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 Communication Tool: Summarizes recommendations for clinicians and patients for surveillance mammography and follow-up care for breast cancer survivors
Overall Study STARTED	45
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Individualizing Surveillance Mammography for Older Breast Cancer Survivors

Baseline characteristics by cohort

Measure	Surveillance Mammography Communication Tool n=45 Participants * 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	45 Participants n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Survey measure on whether mammography will be done or not

Outcome measures

Measure	Surveillance Mammography Communication Tool n=40 Participants * 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
Rate of Change in Intentions for Mammography in the Next Year Intention to undergo mammogram	39 Participants
Rate of Change in Intentions for Mammography in the Next Year Intention to not undergo mammogram	1 Participants

SECONDARY outcome

Timeframe: 2 years

Survey asking about satisfaction with the tool

Outcome measures

Measure	Surveillance Mammography Communication Tool n=40 Participants * 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
Rate of Satisfaction Tool was very, somewhat, or a little helpful	31 Participants
Rate of Satisfaction Tool was not help	6 Participants
Rate of Satisfaction Did not respond	3 Participants

SECONDARY outcome

Timeframe: 2 years

Survey on preferred decision-making style

Outcome measures

Measure	Surveillance Mammography Communication Tool n=45 Participants * 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
Preferred Decision-making Role I prefer to make the final decision.	14 Participants
Preferred Decision-making Role I prefer to make the final decision after seriously considering my health care provider's opinion.	15 Participants
Preferred Decision-making Role I prefer that my health care provider and I share responsibility for deciding .	13 Participants
Preferred Decision-making Role I prefer that my health care provider makes the final decision, but seriously considers my opinion.	3 Participants

Adverse Events

Surveillance Mammography Communication Tool

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rachel Freedman, M.D., M.P.H.

Dana-Farber Cancer Institute

Phone: 617-632-3800

Email: rafreedman@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place