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Trial Outcomes & Findings for Acceptability of Active Monitoring (AM) as a Treatment Option for Ductal Carcinoma in Situ (DCIS) (NCT NCT03775213)

NCT ID: NCT03775213

Last Updated: 2023-01-30

Results Overview

Presented to participants as a categorical item: active monitoring (AM), lumpectomy, lumpectomy with radiation, mastectomy. Recorded for analysis as binary: AM vs non-AM.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

322 participants

Primary outcome timeframe

Up to 1 hour

Results posted on

2023-01-30

Participant Flow

Participants were recruited from Duke mammography clinics between October 2021 and January 2022. The first participant was enrolled on October 12th, 2021 and the last participant was enrolled on January 29th, 2022.

Participant milestones

Participant milestones
Measure
Standard Treatment Options + Active Monitoring (AM)
Participants explore decision support tool that includes current standard treatment options for ductal carcinoma in situ (DCIS), as well as active monitoring (AM). Decision Support Tool with Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including active monitoring and surgery options.
Standard Treatment Options
Participants explore decision support tool that includes current standard treatment options for ductal carcinoma in situ (DCIS). Decision Support Tool without Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only.
Overall Study
STARTED
160
162
Overall Study
COMPLETED
102
102
Overall Study
NOT COMPLETED
58
60

Reasons for withdrawal

Reasons for withdrawal
Measure
Standard Treatment Options + Active Monitoring (AM)
Participants explore decision support tool that includes current standard treatment options for ductal carcinoma in situ (DCIS), as well as active monitoring (AM). Decision Support Tool with Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including active monitoring and surgery options.
Standard Treatment Options
Participants explore decision support tool that includes current standard treatment options for ductal carcinoma in situ (DCIS). Decision Support Tool without Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only.
Overall Study
Withdrawal by Subject
51
53
Overall Study
Incomplete Survey
7
7

Baseline Characteristics

Acceptability of Active Monitoring (AM) as a Treatment Option for Ductal Carcinoma in Situ (DCIS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Standard Treatment Options + Active Monitoring
n=102 Participants
Participants explore decision support tool that includes current standard treatment options for DCIS, as well as active monitoring. Decision Support Tool with Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including active monitoring and surgery options.
Standard Treatment Options
n=102 Participants
Participants explore decision support tool that includes current standard treatment options for DCIS. Decision Support Tool without Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only.
Total
n=204 Participants
Total of all reporting groups
Age, Continuous
64 years
n=5 Participants
62 years
n=7 Participants
62 years
n=5 Participants
Age, Customized
50-64 years
55 Participants
n=5 Participants
61 Participants
n=7 Participants
116 Participants
n=5 Participants
Age, Customized
65-79 years
47 Participants
n=5 Participants
41 Participants
n=7 Participants
88 Participants
n=5 Participants
Sex: Female, Male
Female
102 Participants
n=5 Participants
102 Participants
n=7 Participants
204 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race/Ethnicity, Customized
White
69 Participants
n=5 Participants
63 Participants
n=7 Participants
132 Participants
n=5 Participants
Race/Ethnicity, Customized
Black
29 Participants
n=5 Participants
37 Participants
n=7 Participants
66 Participants
n=5 Participants
Race/Ethnicity, Customized
Other
4 Participants
n=5 Participants
2 Participants
n=7 Participants
6 Participants
n=5 Participants
Marital Status
In Relationship
6 Participants
n=5 Participants
8 Participants
n=7 Participants
14 Participants
n=5 Participants
Marital Status
Married
73 Participants
n=5 Participants
60 Participants
n=7 Participants
133 Participants
n=5 Participants
Marital Status
Divorced
8 Participants
n=5 Participants
13 Participants
n=7 Participants
21 Participants
n=5 Participants
Marital Status
Separated
0 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
Marital Status
Single
14 Participants
n=5 Participants
15 Participants
n=7 Participants
29 Participants
n=5 Participants
Marital Status
Other
1 Participants
n=5 Participants
4 Participants
n=7 Participants
5 Participants
n=5 Participants
Education
Some High School
2 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
Education
High School
14 Participants
n=5 Participants
19 Participants
n=7 Participants
33 Participants
n=5 Participants
Education
Bachelor's Degree
47 Participants
n=5 Participants
40 Participants
n=7 Participants
87 Participants
n=5 Participants
Education
Master's Degree
29 Participants
n=5 Participants
30 Participants
n=7 Participants
59 Participants
n=5 Participants
Education
Professional Degree (e.g., MD, JD)
5 Participants
n=5 Participants
9 Participants
n=7 Participants
14 Participants
n=5 Participants
Education
Doctorate Degree (e.g., PhD)
5 Participants
n=5 Participants
3 Participants
n=7 Participants
8 Participants
n=5 Participants
Household Finances
Extra for special
78 Participants
n=5 Participants
72 Participants
n=7 Participants
150 Participants
n=5 Participants
Household Finances
Just enough
16 Participants
n=5 Participants
23 Participants
n=7 Participants
39 Participants
n=5 Participants
Household Finances
Cut back to pay bills
8 Participants
n=5 Participants
3 Participants
n=7 Participants
11 Participants
n=5 Participants
Household Finances
Difficulty paying bills
0 Participants
n=5 Participants
4 Participants
n=7 Participants
4 Participants
n=5 Participants
Self-Reported Health Status, Median (Q1, Q3)
83 units on a scale
n=5 Participants
85 units on a scale
n=7 Participants
83.5 units on a scale
n=5 Participants
Personal Cancer History
29 Participants
n=5 Participants
25 Participants
n=7 Participants
54 Participants
n=5 Participants
Family Cancer History
86 Participants
n=5 Participants
81 Participants
n=7 Participants
167 Participants
n=5 Participants
Maximizer Minimizer Scale, Median (Q1, Q3)
4.0 units on a scale
n=5 Participants
4.0 units on a scale
n=7 Participants
4.0 units on a scale
n=5 Participants
Graph Literacy Score (0-3), Median (Q1, Q3)
2.0 units on a scale
n=5 Participants
2.0 units on a scale
n=7 Participants
2.0 units on a scale
n=5 Participants
Pre-tool Knowledge (1-5): Breast Cancer
3.0 units on a scale
n=5 Participants
3.0 units on a scale
n=7 Participants
3.0 units on a scale
n=5 Participants
Pre-tool Knowledge (1-5): DCIS
1.0 units on a scale
n=5 Participants
1.0 units on a scale
n=7 Participants
1.0 units on a scale
n=5 Participants

PRIMARY outcome

Timeframe: Up to 1 hour

Presented to participants as a categorical item: active monitoring (AM), lumpectomy, lumpectomy with radiation, mastectomy. Recorded for analysis as binary: AM vs non-AM.

Outcome measures

Outcome measures
Measure
Standard Treatment Options + Active Monitoring
n=102 Participants
Participants explore decision support tool that includes current standard treatment options for DCIS, as well as active monitoring. Decision Support Tool with Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including active monitoring and surgery options.
Standard Treatment Options
n=102 Participants
Participants explore decision support tool that includes current standard treatment options for DCIS. Decision Support Tool without Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only.
Number of Participants Who Chose Active Monitoring (AM).
28 Participants
18 Participants

SECONDARY outcome

Timeframe: Up to 1 hour

Acceptability was ascertained using 1-5 Likert scale. Acceptability, asked in terms of comfort with a given treatment choice, was anchored at 1="Not at all comfortable" and 5="Very comfortable." The outcome was dichotomized using responses of 4 or 5 to represent "Acceptable".

Outcome measures

Outcome measures
Measure
Standard Treatment Options + Active Monitoring
n=102 Participants
Participants explore decision support tool that includes current standard treatment options for DCIS, as well as active monitoring. Decision Support Tool with Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including active monitoring and surgery options.
Standard Treatment Options
n=102 Participants
Participants explore decision support tool that includes current standard treatment options for DCIS. Decision Support Tool without Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only.
Number of Participants Who Found the Treatment Option Acceptable.
Lumpectomy with Radiation
34 Participants
38 Participants
Number of Participants Who Found the Treatment Option Acceptable.
Active Monitoring
32 Participants
32 Participants
Number of Participants Who Found the Treatment Option Acceptable.
Lumpectomy
50 Participants
47 Participants
Number of Participants Who Found the Treatment Option Acceptable.
Mastectomy
18 Participants
22 Participants

SECONDARY outcome

Timeframe: Up to 1 hour

Perceived risk outcome was ascertained using 1-5 Likert scale. Perceived risk was asked for active monitoring only, and was anchored at 1="Not at all risky" and 5="Very risky". The outcome was dichotomized using responses of 4 or 5 to represent "Risky".

Outcome measures

Outcome measures
Measure
Standard Treatment Options + Active Monitoring
n=102 Participants
Participants explore decision support tool that includes current standard treatment options for DCIS, as well as active monitoring. Decision Support Tool with Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including active monitoring and surgery options.
Standard Treatment Options
n=102 Participants
Participants explore decision support tool that includes current standard treatment options for DCIS. Decision Support Tool without Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only.
Number of Participants Who Perceived Active Monitoring as Risky.
18 Participants
17 Participants

SECONDARY outcome

Timeframe: Up to 1 hour

Presented to participants as a categorical item: active monitoring, lumpectomy, lumpectomy with radiation, mastectomy. Recorded for analysis as binary: mastectomy vs non-mastectomy.

Outcome measures

Outcome measures
Measure
Standard Treatment Options + Active Monitoring
n=102 Participants
Participants explore decision support tool that includes current standard treatment options for DCIS, as well as active monitoring. Decision Support Tool with Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including active monitoring and surgery options.
Standard Treatment Options
n=102 Participants
Participants explore decision support tool that includes current standard treatment options for DCIS. Decision Support Tool without Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only.
Number of Participants Who Chose Mastectomy.
14 Participants
15 Participants

SECONDARY outcome

Timeframe: Baseline and 1 hour

Measured pre- and post-tool as a categorical 5-point Likert scale from "I know very little about DCIS" (1) to "I know a lot about DCIS" (5); analyzed as continuous variable.

Outcome measures

Outcome measures
Measure
Standard Treatment Options + Active Monitoring
n=102 Participants
Participants explore decision support tool that includes current standard treatment options for DCIS, as well as active monitoring. Decision Support Tool with Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including active monitoring and surgery options.
Standard Treatment Options
n=102 Participants
Participants explore decision support tool that includes current standard treatment options for DCIS. Decision Support Tool without Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only.
Change in Self-perceived Knowledge About DCIS.
2 Units on a scale
Interval 2.0 to 3.0
2.5 Units on a scale
Interval 2.0 to 3.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 1 hour

Measured pre-tool as 5-point Likert scale from "I know very little about breast cancer" (1) to "I know a lot about breast cancer" (5); analyzed as continuous variable.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 1 hour

Measured post-tool as an open text field.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 1 hour

Measured post-tool as categorical 5-point Likert scale from "Not at all confident" (1) to "Very confident" (5); analyzed as continuous variable.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 1 hour

Measured post-tool as 4-item scale, each item elicited on a 7-point Likert scale; items analyzed separately as continuous variables.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 1 hour

Measured post-tool (3 questions).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 1 hour

Measured post-tool (9 questions).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 1 hour

Measured post-tool as 9-item scale, each item elicited on a 5-point Likert scale from "Not at all" (1) to "A great deal" (5); for each participant, the average score across 9 items is recorded and analyzed as a continuous variable.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 1 hour

Measured post-tool as an open text field.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 1 hour

Measured post-tool as a 7-item scale, each item elicited on a scale from "Rarely" (1) to "Often" (3).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 1 hour

Measured post-tool. Single score derived from 4 items, each scored as correct or incorrect. Correct answers are summed for a total "graph literacy score" (0-4).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 1 hour

Measured post-tool as categorical 6-point Likert scale from "I strongly lean toward waiting and seeing" (1) to "I strongly lean toward taking action" (6); analyzed as continuous variable.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 1 hour

Measured post-tool as an 8-item scale, each item elicited on a 5-point Likert scale from "Strongly disagree" (1) to "Strongly agree" (5).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 1 hour

Measured post-tool as an 4-item scale, each item elicited on a 6-point Likert scale from "Never" (0) to "Always" (5).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 1 hour

Measured post-tool as a 4-item scale, each item elicited on a 6-point Likert scale from "Not at all important compared to other things in my life" (1) to "The very most important thing in my life" (6).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 1 hour

Measured post-tool as a 3-item scale, each item elicited on a 5-point Likert scale from "Not at all" (1) to "Almost all the time" (5)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 1 hour

Self-reported health status (visual analog scale, 0-100).

Outcome measures

Outcome data not reported

Adverse Events

Standard Treatment Options + Active Monitoring

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Standard Treatment Options

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

Dr. Marc D. Ryser

Duke University

Phone: (919) 684 8294

Results disclosure agreements

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