18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Decision Quality: Knowledge SubscalePrimary· Immediately before the index surgical consultation visit, immediately after the index surgical consultation visit and at one week post-surgery
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 1
Immediately before the index surgical consultation visit
Group
Value
95% CI
Arm 1: Option Grid
2.83
± 1.29
Arm 2: Picture Option Grid
2.95
± 1.22
Arm 3: Usual Care
2.77
± 1.21
Immediately after the index surgical consultation visit
Group
Value
95% CI
Arm 1: Option Grid
2.82
± 1.13
Arm 2: Picture Option Grid
2.90
± 1.07
Arm 3: Usual Care
2.74
± 1.07
One week post-surgery
Group
Value
95% CI
Arm 1: Option Grid
3.00
± 1.11
Arm 2: Picture Option Grid
2.88
± 1.05
Arm 3: Usual Care
2.87
± 1.12
Change in Decision Quality: Decison Process SubscalePrimary· Immediately after the index surgical consultation visit and at one week post-surgery
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 from 0 to 7 with higher numbers indicating higher shared decision process. For the concordance score, patients rated their goals and conc
Immediately after the index surgical consultation visit
Group
Value
95% CI
Arm 1: Option Grid
5.66
± 1.24
Arm 2: Picture Option Grid
5.47
± 1.58
Arm 3: Usual Care
4.57
± 2.10
One week post-surgery
Group
Value
95% CI
Arm 1: Option Grid
5.67
± 1.26
Arm 2: Picture Option Grid
5.02
± 1.73
Arm 3: Usual Care
4.64
± 1.95
Change in Decision Quality: Concordance SubscalePrimary· Immediately after the index surgical consultation visit and at one week post-surgery
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 1
Group
Value
95% CI
Arm 1: Option Grid
95.3
Arm 2: Picture Option Grid
92.9
Arm 3: Usual Care
95.4
Number of Participants Who Chose Lumpectomy or Mastectomy as Their Treatment ChoiceSecondary· 1 week post-surgery
Treatment choice, or which surgical or treatment option the patient chose, mastectomy or lumpectomy (breast conserving surgery)
Group
Value
95% CI
Arm 1: Option Grid
42
Arm 2: Picture Option Grid
161
Arm 3: Usual Care
146
Arm 1: Option Grid
10
Arm 2: Picture Option Grid
39
Arm 3: Usual Care
46
Change in Quality of LifeSecondary· Immediately before the index surgical consultation visit and at 12 weeks post-surgery
Quality 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.
Immediately before the index surgical consultation visit
Group
Value
95% CI
Arm 1: Option Grid
0.83
± 0.13
Arm 2: Picture Option Grid
0.82
± 0.13
Arm 3: Usual Care
0.82
± 0.14
12 weeks post-surgery
Group
Value
95% CI
Arm 1: Option Grid
0.82
± 0.10
Arm 2: Picture Option Grid
0.85
± 0.13
Arm 3: Usual Care
0.82
± 0.12
AnxietySecondary· Immediately before the index surgical consultation visit, immediately after the index surgical consultation visit, at 1 week post-surgery, and at 12 weeks post-surgery
Patient-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.
Immediately before the index surgical consultation visit
Group
Value
95% CI
Arm 1: Option Grid
20.8
± 6.8
Arm 2: Picture Option Grid
20.2
± 7.4
Arm 3: Usual Care
20.7
± 7.7
immediately after the index surgical consultation visit
Group
Value
95% CI
Arm 1: Option Grid
20.0
± 6.7
Arm 2: Picture Option Grid
20.4
± 8.1
Arm 3: Usual Care
20.6
± 7.9
1 week post-surgery
Group
Value
95% CI
Arm 1: Option Grid
17.2
± 7.3
Arm 2: Picture Option Grid
17.0
± 7.1
Arm 3: Usual Care
17.1
± 6.7
12 weeks post-surgery
Group
Value
95% CI
Arm 1: Option Grid
13.1
± 6.5
Arm 2: Picture Option Grid
13.0
± 5.6
Arm 3: Usual Care
14.9
± 6.9
Shared Decision-making (Self-reported)Secondary· Immediately after the index surgical consultation visit
Self-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.
Group
Value
95% CI
Arm 1: Option Grid
73
48 – 99
Arm 2: Picture Option Grid
76
55 – 97
Arm 3: Usual Care
58
52 – 65
Shared Decision-making (Observed)Secondary· During the index surgical consultation visit
Shared 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
Group
Value
95% CI
Arm 1: Option Grid
69.92
42.51 – 95.16
Arm 2: Picture Option Grid
65.72
41.84 – 89.45
Arm 3: Usual Care
41.02
36.20 – 45.85
Decision RegretSecondary· At 1 week post-surgery, 12 weeks post-surgery, and 1 year post-surgery
Patient-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.
1 week post-surgery
Group
Value
95% CI
Arm 1: Option Grid
10.9
± 13.9
Arm 2: Picture Option Grid
8.1
± 12.3
Arm 3: Usual Care
12.9
± 14.5
12 weeks post-surgery
Group
Value
95% CI
Arm 1: Option Grid
12.0
± 15.9
Arm 2: Picture Option Grid
7.6
± 12.3
Arm 3: Usual Care
10.8
± 16.2
1 year post-surgery
Group
Value
95% CI
Arm 1: Option Grid
10.4
± 14.1
Arm 2: Picture Option Grid
6.0
± 10.3
Arm 3: Usual Care
7.6
± 14.3
Integration of Health Care DeliverySecondary· Immediately before the index surgical consultation visit and at 12 weeks post-surgery
Patient-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.
Immediately before the index surgical consultation visit
Group
Value
95% CI
Arm 1: Option Grid
10.4
± 1.8
Arm 2: Picture Option Grid
10.2
± 2.0
Arm 3: Usual Care
10.3
± 1.9
12 weeks post-surgery
Group
Value
95% CI
Arm 1: Option Grid
10.9
± 1.1
Arm 2: Picture Option Grid
10.8
± 1.5
Arm 3: Usual Care
10.6
± 1.8
Exploration of Strategies That Promote the Interventions' Sustained Use and DisseminationSecondary· 12 weeks post-surgery (patients) or after trial participation ended (surgeons)
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
Patients
Group
Value
95% CI
Patients in Intervention Arms
30
Patients in Intervention Arms
29
Patients in Intervention Arms
40
Patients in Intervention Arms
30
All trial surgeons
Group
Value
95% CI
Surgeons Involved in the Trial
NA
Surgeons Involved in the Trial
NA
Surgeons Involved in the Trial
NA
Surgeons Involved in the Trial
NA
Intervention surgeons
Group
Value
95% CI
Surgeons Involved in the Trial
NA
Surgeons Involved in the Trial
NA
Surgeons Involved in the Trial
NA
Surgeons Involved in the Trial
NA
Sponsor's own description
What Matters Most is a study that aims to determine how best to help women of lower socioeconomic status make high-quality decisions about early stage breast cancer treatments. What Matters Most will be comparing two decision aids used in the clinic visit to usual care (what normally happens in the clinic). The first decision aid (Option Grid) presents evidence-based information about lumpectomy and mastectomy in a tabular format using text only. The second decision aid (Picture Option Grid) presents evidence-based information about lumpectomy and mastectomy using pictures, pictographs and simplified text. What Matters Most aims to show that the interventions can reduce disparities in decision-making and treatment choice between women of high and low SES.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Dartmouth-Hitchcock Medical Center
Last refreshed: 5 January 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03136367.