Trial Outcomes & Findings for What Matters Most: Choosing the Right Breast Cancer Surgery for You (NCT NCT03136367)
NCT ID: NCT03136367
Last Updated: 2021-01-05
Results Overview
Change in decision quality, measured using the validated 16-item Decision Quality Worksheet for Breast Cancer Surgery. Decision quality is measured through three constructs: knowledge, decision process, and concordance. Knowledge is five questions that results in a score from 0 to 5 with higher numbers indicating higher knowledge. Decision process is a measure how much shared decision making process occurred, based on patient-report. It is a seven-item scale with higher numbers indicating higher shared decision process. For the concordance score, patients rated their goals and concerns on an 11-point importance scale from 0 (not important at all) to 10 (extremely important). They also indicated which surgery they intended to have at T2. A concordance summary score (0-100%) indicated the percentage of patients who received a treatment that matched their stated preference.
COMPLETED
NA
571 participants
Immediately before the index surgical consultation visit, immediately after the index surgical consultation visit and at one week post-surgery
2021-01-05
Participant Flow
Between September 2017 and February 2019, we screened 2,057 of a target 2,200 patients; 1,031 patients remained eligible. We approached 885 eligible patients, of which 622 (76.6%) consented. Sixteen surgeons saw 571 of 622 consented patients.
Sixteen surgeons saw 571 of 622 consented patients. The imbalanced allocation to arms was due to differences in the number of patients seen by each surgeon, or changes in their role or attendance. Of 440 patients who consented to recording, we collected 311 (70.7%) usable recordings.
Participant milestones
| Measure |
Arm 1: Option Grid
Patients in this arm will receive the Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.
Option Grid: The Option Grid(TM) encounter decision aid for early stage breast cancer surgery is a one-page, evidence-based summary of available options presented in a tabular format.
|
Arm 2: Picture Option Grid
Patients in this arm will receive the Picture Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.
Picture Option Grid: The Picture Option Grid was derived from the Option Grid for early stage breast cancer. It uses the same evidence and integrates images and simpler text, thus exploiting pictorial superiority. The Picture Option Grid has been specifically designed for women of lower SES and low health literacy.
|
Arm 3: Usual Care
In the usual care arm, surgeons provided their standard information about breast cancer.
|
|---|---|---|---|
|
T1 Consultation
STARTED
|
66
|
248
|
257
|
|
T1 Consultation
COMPLETED
|
64
|
241
|
256
|
|
T1 Consultation
NOT COMPLETED
|
2
|
7
|
1
|
|
T2 Post-consultation
STARTED
|
64
|
241
|
256
|
|
T2 Post-consultation
COMPLETED
|
61
|
235
|
225
|
|
T2 Post-consultation
NOT COMPLETED
|
3
|
6
|
31
|
|
T3 1 Week After Surgery
STARTED
|
61
|
235
|
225
|
|
T3 1 Week After Surgery
COMPLETED
|
51
|
203
|
194
|
|
T3 1 Week After Surgery
NOT COMPLETED
|
10
|
32
|
31
|
|
T4 12 Weeks After Surgery
STARTED
|
51
|
203
|
194
|
|
T4 12 Weeks After Surgery
COMPLETED
|
49
|
198
|
185
|
|
T4 12 Weeks After Surgery
NOT COMPLETED
|
2
|
5
|
9
|
|
T5 1 Year After Surgery
STARTED
|
49
|
198
|
185
|
|
T5 1 Year After Surgery
COMPLETED
|
13
|
62
|
56
|
|
T5 1 Year After Surgery
NOT COMPLETED
|
36
|
136
|
129
|
Reasons for withdrawal
| Measure |
Arm 1: Option Grid
Patients in this arm will receive the Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.
Option Grid: The Option Grid(TM) encounter decision aid for early stage breast cancer surgery is a one-page, evidence-based summary of available options presented in a tabular format.
|
Arm 2: Picture Option Grid
Patients in this arm will receive the Picture Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.
Picture Option Grid: The Picture Option Grid was derived from the Option Grid for early stage breast cancer. It uses the same evidence and integrates images and simpler text, thus exploiting pictorial superiority. The Picture Option Grid has been specifically designed for women of lower SES and low health literacy.
|
Arm 3: Usual Care
In the usual care arm, surgeons provided their standard information about breast cancer.
|
|---|---|---|---|
|
T1 Consultation
discontinued mistakenly included
|
2
|
6
|
1
|
|
T1 Consultation
Discontinued other
|
0
|
1
|
0
|
|
T2 Post-consultation
Withdrawal by Subject
|
1
|
1
|
5
|
|
T2 Post-consultation
discontinued mistakenly included
|
2
|
2
|
17
|
|
T2 Post-consultation
Discontinued other
|
0
|
2
|
6
|
|
T2 Post-consultation
Discontinued transferred care
|
0
|
0
|
3
|
|
T2 Post-consultation
Discontinued lost contact
|
0
|
1
|
0
|
|
T3 1 Week After Surgery
Discontinued mistakenly included
|
5
|
9
|
8
|
|
T3 1 Week After Surgery
Discontinued transferred care
|
2
|
11
|
14
|
|
T3 1 Week After Surgery
other discontinued
|
2
|
4
|
3
|
|
T3 1 Week After Surgery
Withdrawal by Subject
|
0
|
6
|
2
|
|
T3 1 Week After Surgery
Discontinued lost contact
|
1
|
2
|
4
|
|
T4 12 Weeks After Surgery
Withdrawal by Subject
|
1
|
3
|
0
|
|
T4 12 Weeks After Surgery
Death
|
0
|
1
|
3
|
|
T4 12 Weeks After Surgery
discontinued lost contact
|
1
|
0
|
0
|
|
T4 12 Weeks After Surgery
discontinued transferred care
|
0
|
1
|
5
|
|
T4 12 Weeks After Surgery
discontinued mistakenly included
|
0
|
0
|
1
|
|
T5 1 Year After Surgery
discontinued mistakenly included
|
1
|
1
|
1
|
|
T5 1 Year After Surgery
Withdrawal by Subject
|
1
|
0
|
0
|
|
T5 1 Year After Surgery
Death
|
0
|
0
|
1
|
|
T5 1 Year After Surgery
Discontinued lost contact
|
1
|
6
|
0
|
|
T5 1 Year After Surgery
Lost to Follow-up
|
2
|
22
|
15
|
|
T5 1 Year After Surgery
study ended before due
|
31
|
103
|
110
|
|
T5 1 Year After Surgery
logistical issues prevented contact
|
0
|
4
|
2
|
Baseline Characteristics
What Matters Most: Choosing the Right Breast Cancer Surgery for You
Baseline characteristics by cohort
| Measure |
Arm 1: Option Grid
n=69 Participants
Patients in this arm will receive the Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.
Option Grid: The Option Grid(TM) encounter decision aid for early stage breast cancer surgery is a one-page, evidence-based summary of available options presented in a tabular format.
|
Arm 2: Picture Option Grid
n=276 Participants
Patients in this arm will receive the Picture Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.
Picture Option Grid: The Picture Option Grid was derived from the Option Grid for early stage breast cancer. It uses the same evidence and integrates images and simpler text, thus exploiting pictorial superiority. The Picture Option Grid has been specifically designed for women of lower SES and low health literacy.
|
Arm 3: Usual Care
n=271 Participants
In the usual care arm, surgeons provided their standard information about breast cancer
|
Total
n=616 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.1 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
58.9 years
STANDARD_DEVIATION 13.0 • n=7 Participants
|
60.4 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
59.7 years
STANDARD_DEVIATION 12.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
276 Participants
n=7 Participants
|
271 Participants
n=5 Participants
|
616 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
218 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
472 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Immediately before the index surgical consultation visit, immediately after the index surgical consultation visit and at one week post-surgeryChange in decision quality, measured using the validated 16-item Decision Quality Worksheet for Breast Cancer Surgery. Decision quality is measured through three constructs: knowledge, decision process, and concordance. Knowledge is five questions that results in a score from 0 to 5 with higher numbers indicating higher knowledge. Decision process is a measure how much shared decision making process occurred, based on patient-report. It is a seven-item scale with higher numbers indicating higher shared decision process. For the concordance score, patients rated their goals and concerns on an 11-point importance scale from 0 (not important at all) to 10 (extremely important). They also indicated which surgery they intended to have at T2. A concordance summary score (0-100%) indicated the percentage of patients who received a treatment that matched their stated preference.
Outcome measures
| Measure |
Arm 1: Option Grid
n=66 Participants
Patients in this arm will receive the Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.
Option Grid: The Option Grid(TM) encounter decision aid for early stage breast cancer surgery is a one-page, evidence-based summary of available options presented in a tabular format.
|
Arm 2: Picture Option Grid
n=248 Participants
Patients in this arm will receive the Picture Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.
Picture Option Grid: The Picture Option Grid was derived from the Option Grid for early stage breast cancer. It uses the same evidence and integrates images and simpler text, thus exploiting pictorial superiority. The Picture Option Grid has been specifically designed for women of lower SES and low health literacy.
|
Arm 3: Usual Care
n=257 Participants
In the usual care arm, surgeons provided their standard information about breast cancer.
|
|---|---|---|---|
|
Change in Decision Quality: Knowledge Subscale
Immediately before the index surgical consultation visit
|
2.83 score on a scale
Standard Deviation 1.29
|
2.95 score on a scale
Standard Deviation 1.22
|
2.77 score on a scale
Standard Deviation 1.21
|
|
Change in Decision Quality: Knowledge Subscale
Immediately after the index surgical consultation visit
|
2.82 score on a scale
Standard Deviation 1.13
|
2.90 score on a scale
Standard Deviation 1.07
|
2.74 score on a scale
Standard Deviation 1.07
|
|
Change in Decision Quality: Knowledge Subscale
One week post-surgery
|
3.00 score on a scale
Standard Deviation 1.11
|
2.88 score on a scale
Standard Deviation 1.05
|
2.87 score on a scale
Standard Deviation 1.12
|
PRIMARY outcome
Timeframe: Immediately after the index surgical consultation visit and at one week post-surgeryChange in decision quality, measured using the validated 16-item Decision Quality Worksheet for Breast Cancer Surgery. Decision quality is measured through three constructs: knowledge, decision process, and concordance. Knowledge is five questions that results in a score from 0 to 5 with higher numbers indicating higher knowledge. Decision process is a measure how much shared decision making process occurred, based on patient-report. It is a seven-item scale from 0 to 7 with higher numbers indicating higher shared decision process. For the concordance score, patients rated their goals and concerns on an 11-point importance scale from 0 (not important at all) to 10 (extremely important). They also indicated which surgery they intended to have at T2. A concordance score indicated the percentage of patients who received a treatment that matched their stated preference.
Outcome measures
| Measure |
Arm 1: Option Grid
n=66 Participants
Patients in this arm will receive the Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.
Option Grid: The Option Grid(TM) encounter decision aid for early stage breast cancer surgery is a one-page, evidence-based summary of available options presented in a tabular format.
|
Arm 2: Picture Option Grid
n=248 Participants
Patients in this arm will receive the Picture Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.
Picture Option Grid: The Picture Option Grid was derived from the Option Grid for early stage breast cancer. It uses the same evidence and integrates images and simpler text, thus exploiting pictorial superiority. The Picture Option Grid has been specifically designed for women of lower SES and low health literacy.
|
Arm 3: Usual Care
n=257 Participants
In the usual care arm, surgeons provided their standard information about breast cancer.
|
|---|---|---|---|
|
Change in Decision Quality: Decison Process Subscale
Immediately after the index surgical consultation visit
|
5.66 score on a scale
Standard Deviation 1.24
|
5.47 score on a scale
Standard Deviation 1.58
|
4.57 score on a scale
Standard Deviation 2.10
|
|
Change in Decision Quality: Decison Process Subscale
One week post-surgery
|
5.67 score on a scale
Standard Deviation 1.26
|
5.02 score on a scale
Standard Deviation 1.73
|
4.64 score on a scale
Standard Deviation 1.95
|
PRIMARY outcome
Timeframe: Immediately after the index surgical consultation visit and at one week post-surgeryPopulation: Only participants who remained in the trial through when they had their surgery were analyzed for this outcome in order to assess the match between treatment intent and treatment received.
Change in decision quality, measured using the validated 16-item Decision Quality Worksheet for Breast Cancer Surgery. Decision quality is measured through three constructs: knowledge, decision process, and concordance. Knowledge is five questions that results in a score from 0 to 5 with higher numbers indicating higher knowledge. Decision process is a measure how much shared decision making process occurred, based on patient-report. It is a seven-item scale with higher numbers indicating higher shared decision process. For the concordance score, patients rated their goals and concerns on an 11-point importance scale from 0 (not important at all) to 10 (extremely important). They also indicated which surgery they intended to have at T2. A concordance summary score (0-100%) indicated the percentage of patients who received a treatment that matched their stated preference at T2 (lumpectomy vs mastectomy).
Outcome measures
| Measure |
Arm 1: Option Grid
n=43 Participants
Patients in this arm will receive the Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.
Option Grid: The Option Grid(TM) encounter decision aid for early stage breast cancer surgery is a one-page, evidence-based summary of available options presented in a tabular format.
|
Arm 2: Picture Option Grid
n=148 Participants
Patients in this arm will receive the Picture Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.
Picture Option Grid: The Picture Option Grid was derived from the Option Grid for early stage breast cancer. It uses the same evidence and integrates images and simpler text, thus exploiting pictorial superiority. The Picture Option Grid has been specifically designed for women of lower SES and low health literacy.
|
Arm 3: Usual Care
n=168 Participants
In the usual care arm, surgeons provided their standard information about breast cancer.
|
|---|---|---|---|
|
Change in Decision Quality: Concordance Subscale
|
95.3 percentage with treatment match
|
92.9 percentage with treatment match
|
95.4 percentage with treatment match
|
SECONDARY outcome
Timeframe: 1 week post-surgeryPopulation: The number of participants analyzed for treatment choice was different from other outcome measures as it is based on the number of participants for whom treatment choice data was available.
Treatment choice, or which surgical or treatment option the patient chose, mastectomy or lumpectomy (breast conserving surgery)
Outcome measures
| Measure |
Arm 1: Option Grid
n=52 Participants
Patients in this arm will receive the Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.
Option Grid: The Option Grid(TM) encounter decision aid for early stage breast cancer surgery is a one-page, evidence-based summary of available options presented in a tabular format.
|
Arm 2: Picture Option Grid
n=200 Participants
Patients in this arm will receive the Picture Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.
Picture Option Grid: The Picture Option Grid was derived from the Option Grid for early stage breast cancer. It uses the same evidence and integrates images and simpler text, thus exploiting pictorial superiority. The Picture Option Grid has been specifically designed for women of lower SES and low health literacy.
|
Arm 3: Usual Care
n=192 Participants
In the usual care arm, surgeons provided their standard information about breast cancer.
|
|---|---|---|---|
|
Number of Participants Who Chose Lumpectomy or Mastectomy as Their Treatment Choice
lumpectomy
|
42 Participants
|
161 Participants
|
146 Participants
|
|
Number of Participants Who Chose Lumpectomy or Mastectomy as Their Treatment Choice
mastectomy
|
10 Participants
|
39 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: Immediately before the index surgical consultation visit and at 12 weeks post-surgeryQuality of life reported by the patient measured using the validated 6-item EQ-5D-5L measure. We used the available resources from EuroQol to convert EQ-5D-5L states into an index value, using the EQ-5D-5L crosswalk value sets. Index values ranged from full health (1) and to no health (-0.109), according to the US crosswalk value set.
Outcome measures
| Measure |
Arm 1: Option Grid
n=66 Participants
Patients in this arm will receive the Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.
Option Grid: The Option Grid(TM) encounter decision aid for early stage breast cancer surgery is a one-page, evidence-based summary of available options presented in a tabular format.
|
Arm 2: Picture Option Grid
n=248 Participants
Patients in this arm will receive the Picture Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.
Picture Option Grid: The Picture Option Grid was derived from the Option Grid for early stage breast cancer. It uses the same evidence and integrates images and simpler text, thus exploiting pictorial superiority. The Picture Option Grid has been specifically designed for women of lower SES and low health literacy.
|
Arm 3: Usual Care
n=257 Participants
In the usual care arm, surgeons provided their standard information about breast cancer.
|
|---|---|---|---|
|
Change in Quality of Life
Immediately before the index surgical consultation visit
|
0.83 score on a scale
Standard Deviation 0.13
|
0.82 score on a scale
Standard Deviation 0.13
|
0.82 score on a scale
Standard Deviation 0.14
|
|
Change in Quality of Life
12 weeks post-surgery
|
0.82 score on a scale
Standard Deviation 0.10
|
0.85 score on a scale
Standard Deviation 0.13
|
0.82 score on a scale
Standard Deviation 0.12
|
SECONDARY outcome
Timeframe: Immediately before the index surgical consultation visit, immediately after the index surgical consultation visit, at 1 week post-surgery, and at 12 weeks post-surgeryPatient-reported anxiety, measured using the validated 8-item PROMIS anxiety short form. Each question was coded from one to five. Total scores were obtained by scoring the raw score of each item answered. The lowest possible raw score was 8; the highest possible raw score was 40 with higher numbers indicating higher anxiety.
Outcome measures
| Measure |
Arm 1: Option Grid
n=66 Participants
Patients in this arm will receive the Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.
Option Grid: The Option Grid(TM) encounter decision aid for early stage breast cancer surgery is a one-page, evidence-based summary of available options presented in a tabular format.
|
Arm 2: Picture Option Grid
n=248 Participants
Patients in this arm will receive the Picture Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.
Picture Option Grid: The Picture Option Grid was derived from the Option Grid for early stage breast cancer. It uses the same evidence and integrates images and simpler text, thus exploiting pictorial superiority. The Picture Option Grid has been specifically designed for women of lower SES and low health literacy.
|
Arm 3: Usual Care
n=257 Participants
In the usual care arm, surgeons provided their standard information about breast cancer.
|
|---|---|---|---|
|
Anxiety
Immediately before the index surgical consultation visit
|
20.8 score on a scale
Standard Deviation 6.8
|
20.2 score on a scale
Standard Deviation 7.4
|
20.7 score on a scale
Standard Deviation 7.7
|
|
Anxiety
immediately after the index surgical consultation visit
|
20.0 score on a scale
Standard Deviation 6.7
|
20.4 score on a scale
Standard Deviation 8.1
|
20.6 score on a scale
Standard Deviation 7.9
|
|
Anxiety
1 week post-surgery
|
17.2 score on a scale
Standard Deviation 7.3
|
17.0 score on a scale
Standard Deviation 7.1
|
17.1 score on a scale
Standard Deviation 6.7
|
|
Anxiety
12 weeks post-surgery
|
13.1 score on a scale
Standard Deviation 6.5
|
13.0 score on a scale
Standard Deviation 5.6
|
14.9 score on a scale
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: Immediately after the index surgical consultation visitSelf-reported shared decision-making about breast cancer surgical options measured using the validated 3-item CollaboRATE measure. Each item was rated on a scale from 0 to 9 with a possible score range from 0 to 27. We dichotomized this measure using the top score approach, grouping participants scoring 9 on all three items versus all others.
Outcome measures
| Measure |
Arm 1: Option Grid
n=66 Participants
Patients in this arm will receive the Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.
Option Grid: The Option Grid(TM) encounter decision aid for early stage breast cancer surgery is a one-page, evidence-based summary of available options presented in a tabular format.
|
Arm 2: Picture Option Grid
n=248 Participants
Patients in this arm will receive the Picture Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.
Picture Option Grid: The Picture Option Grid was derived from the Option Grid for early stage breast cancer. It uses the same evidence and integrates images and simpler text, thus exploiting pictorial superiority. The Picture Option Grid has been specifically designed for women of lower SES and low health literacy.
|
Arm 3: Usual Care
n=257 Participants
In the usual care arm, surgeons provided their standard information about breast cancer.
|
|---|---|---|---|
|
Shared Decision-making (Self-reported)
|
73 percentage of patients with a top score
Interval 48.0 to 99.0
|
76 percentage of patients with a top score
Interval 55.0 to 97.0
|
58 percentage of patients with a top score
Interval 52.0 to 65.0
|
SECONDARY outcome
Timeframe: During the index surgical consultation visitShared decision-making observed during the surgical consultation, measured using the validated observer-rated OPTION5. The five items on the measure ask raters to score the consultation on how much the clinician: 1) confirms that alternatives exist, 2) reassures that they will support the patient to become informed, 3) gives information or checks understanding about the options, 4) makes an effort to elicit the patient's preferences, and 5) integrates the patient's elicited preferences. Each of the five items is scored from zero to four for a summary score ranging from zero to 20 and a scaled score ranging from zero to 100. Higher numbers indicate more shared decision making was observed.
Outcome measures
| Measure |
Arm 1: Option Grid
n=41 Participants
Patients in this arm will receive the Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.
Option Grid: The Option Grid(TM) encounter decision aid for early stage breast cancer surgery is a one-page, evidence-based summary of available options presented in a tabular format.
|
Arm 2: Picture Option Grid
n=143 Participants
Patients in this arm will receive the Picture Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.
Picture Option Grid: The Picture Option Grid was derived from the Option Grid for early stage breast cancer. It uses the same evidence and integrates images and simpler text, thus exploiting pictorial superiority. The Picture Option Grid has been specifically designed for women of lower SES and low health literacy.
|
Arm 3: Usual Care
n=127 Participants
In the usual care arm, surgeons provided their standard information about breast cancer.
|
|---|---|---|---|
|
Shared Decision-making (Observed)
|
69.92 score on a scale
Interval 42.51 to 95.16
|
65.72 score on a scale
Interval 41.84 to 89.45
|
41.02 score on a scale
Interval 36.2 to 45.85
|
SECONDARY outcome
Timeframe: At 1 week post-surgery, 12 weeks post-surgery, and 1 year post-surgeryPatient-reported feelings of decision regret, measured using the validated 5-item decision regret scale. Items 2 and 4 were reverse coded so a higher number indicated more regret. Scores were then converted to a 0-100 scale by subtracting 1 from each item then multiply by 25. To obtain a final score, the items were summed and averaged. A score of 0 meant no regret and a score of 100 meant high regret.
Outcome measures
| Measure |
Arm 1: Option Grid
n=66 Participants
Patients in this arm will receive the Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.
Option Grid: The Option Grid(TM) encounter decision aid for early stage breast cancer surgery is a one-page, evidence-based summary of available options presented in a tabular format.
|
Arm 2: Picture Option Grid
n=248 Participants
Patients in this arm will receive the Picture Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.
Picture Option Grid: The Picture Option Grid was derived from the Option Grid for early stage breast cancer. It uses the same evidence and integrates images and simpler text, thus exploiting pictorial superiority. The Picture Option Grid has been specifically designed for women of lower SES and low health literacy.
|
Arm 3: Usual Care
n=257 Participants
In the usual care arm, surgeons provided their standard information about breast cancer.
|
|---|---|---|---|
|
Decision Regret
1 week post-surgery
|
10.9 score on a scale
Standard Deviation 13.9
|
8.1 score on a scale
Standard Deviation 12.3
|
12.9 score on a scale
Standard Deviation 14.5
|
|
Decision Regret
12 weeks post-surgery
|
12.0 score on a scale
Standard Deviation 15.9
|
7.6 score on a scale
Standard Deviation 12.3
|
10.8 score on a scale
Standard Deviation 16.2
|
|
Decision Regret
1 year post-surgery
|
10.4 score on a scale
Standard Deviation 14.1
|
6.0 score on a scale
Standard Deviation 10.3
|
7.6 score on a scale
Standard Deviation 14.3
|
SECONDARY outcome
Timeframe: Immediately before the index surgical consultation visit and at 12 weeks post-surgeryPatient-reported measure of integration of healthcare delivery, measured using IntegRATE, a 4-item scale. IntegRATE sum scores are determined by summing each participant's scores across the 4 items (range 0-12). A higher score indicates higher integration.
Outcome measures
| Measure |
Arm 1: Option Grid
n=66 Participants
Patients in this arm will receive the Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.
Option Grid: The Option Grid(TM) encounter decision aid for early stage breast cancer surgery is a one-page, evidence-based summary of available options presented in a tabular format.
|
Arm 2: Picture Option Grid
n=248 Participants
Patients in this arm will receive the Picture Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.
Picture Option Grid: The Picture Option Grid was derived from the Option Grid for early stage breast cancer. It uses the same evidence and integrates images and simpler text, thus exploiting pictorial superiority. The Picture Option Grid has been specifically designed for women of lower SES and low health literacy.
|
Arm 3: Usual Care
n=257 Participants
In the usual care arm, surgeons provided their standard information about breast cancer.
|
|---|---|---|---|
|
Integration of Health Care Delivery
Immediately before the index surgical consultation visit
|
10.4 score on a scale
Standard Deviation 1.8
|
10.2 score on a scale
Standard Deviation 2.0
|
10.3 score on a scale
Standard Deviation 1.9
|
|
Integration of Health Care Delivery
12 weeks post-surgery
|
10.9 score on a scale
Standard Deviation 1.1
|
10.8 score on a scale
Standard Deviation 1.5
|
10.6 score on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: 12 weeks post-surgery (patients) or after trial participation ended (surgeons)Population: The results are reported in two groups: patients and all surgeons. The data collection method used was semi-structured interview (using a purposive sampling technique). This was a qualitative exploration of the data. We did not interview all participants but only purposively selected 42 participants in the intervention arms. Some results in this section only apply to patients (e.g., helped with decision) and some only apply to surgeons (e.g., would recommend to other health professionals).
Semi-structured interviews with clinic stakeholders and patients 12 weeks post-surgery, field notes, and clinic observations to explore strategies that promote the interventions' sustained use and dissemination
Outcome measures
| Measure |
Arm 1: Option Grid
n=42 Participants
Patients in this arm will receive the Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.
Option Grid: The Option Grid(TM) encounter decision aid for early stage breast cancer surgery is a one-page, evidence-based summary of available options presented in a tabular format.
|
Arm 2: Picture Option Grid
n=16 Participants
Patients in this arm will receive the Picture Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.
Picture Option Grid: The Picture Option Grid was derived from the Option Grid for early stage breast cancer. It uses the same evidence and integrates images and simpler text, thus exploiting pictorial superiority. The Picture Option Grid has been specifically designed for women of lower SES and low health literacy.
|
Arm 3: Usual Care
In the usual care arm, surgeons provided their standard information about breast cancer.
|
|---|---|---|---|
|
Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination
All trial surgeons · Open to receiving the aid in virtual formats
|
—
|
NA Participants
This category/result only applies to patients.
|
—
|
|
Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination
Patients · Aid affected treatment decision
|
30 Participants
|
—
|
—
|
|
Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination
Patients · Aid was part of normal routine
|
29 Participants
|
—
|
—
|
|
Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination
Patients · Want paper-based materials
|
40 Participants
|
—
|
—
|
|
Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination
Patients · Thought receiving aid from the surgeon is best
|
30 Participants
|
—
|
—
|
|
Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination
Patients · Open to receiving the aid in virtual formats
|
30 Participants
|
—
|
—
|
|
Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination
Patients · Open to receiving/giving aid before appointment
|
15 Participants
|
—
|
—
|
|
Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination
Patients · Aid would be helpful for lower literacy patients
|
NA Participants
This category/result only applies to surgeons.
|
—
|
—
|
|
Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination
Patients · Recommended other health professionals use the aid
|
NA Participants
This category/result only applies to surgeons.
|
—
|
—
|
|
Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination
Patients · Were able to integrate the aid into their routine
|
NA Participants
This category/result only applies to surgeons.
|
—
|
—
|
|
Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination
All trial surgeons · Aid affected treatment decision
|
—
|
NA Participants
This category/result only applies to patients.
|
—
|
|
Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination
All trial surgeons · Aid was part of normal routine
|
—
|
NA Participants
This category/result only applies to patients.
|
—
|
|
Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination
All trial surgeons · Want paper-based materials
|
—
|
NA Participants
This category/result only applies to patients.
|
—
|
|
Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination
All trial surgeons · Thought receiving aid from the surgeon is best
|
—
|
NA Participants
This category/result only applies to patients.
|
—
|
|
Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination
All trial surgeons · Open to receiving/giving aid before appointment
|
—
|
8 Participants
|
—
|
|
Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination
All trial surgeons · Aid would be helpful for lower literacy patients
|
—
|
NA Participants
This category/result only applies to surgeons in the intervention arms.
|
—
|
|
Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination
All trial surgeons · Recommended other health professionals use the aid
|
—
|
16 Participants
|
—
|
|
Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination
All trial surgeons · Were able to integrate the aid into their routine
|
—
|
NA Participants
This category/result only applies to surgeons in the intervention arms.
|
—
|
|
Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination
Intervention surgeons · Aid affected treatment decision
|
—
|
NA Participants
This category/result only applies to patients.
|
—
|
|
Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination
Intervention surgeons · Aid was part of normal routine
|
—
|
NA Participants
This category/result only applies to patients.
|
—
|
|
Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination
Intervention surgeons · Want paper-based materials
|
—
|
NA Participants
This category/result only applies to patients.
|
—
|
|
Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination
Intervention surgeons · Thought receiving aid from the surgeon is best
|
—
|
NA Participants
This category/result only applies to patients.
|
—
|
|
Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination
Intervention surgeons · Open to receiving the aid in virtual formats
|
—
|
NA Participants
This category/result only applies to patients.
|
—
|
|
Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination
Intervention surgeons · Open to receiving/giving aid before appointment
|
—
|
NA Participants
This category/result only applies to patients or the entire surgeon group analysis.
|
—
|
|
Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination
Intervention surgeons · Aid would be helpful for lower literacy patients
|
—
|
6 Participants
|
—
|
|
Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination
Intervention surgeons · Recommended other health professionals use the aid
|
—
|
NA Participants
This category/result only applies to patients or the entire surgeon group analysis.
|
—
|
|
Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination
Intervention surgeons · Were able to integrate the aid into their routine
|
—
|
8 Participants
|
—
|
Adverse Events
Arm 1: Option Grid
Arm 2: Picture Option Grid
Arm 3: Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place