N/A
N=571
What Matters Most: Choosing the Right Breast Cancer Surgery for You
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03136367 ↗Enrolled (actual)
571
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Change in Decision Quality: Knowledge Subscale — 2.83; 2.95; 2.77; 2.82 score on a scale — p=0.045
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Option Grid (Other); Picture Option Grid (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Decision Quality: Knowledge Subscale |
2.83; 2.95; 2.77; 2.82; 2.90; 2.74 | 0.045 sig |
| PRIMARY Change in Decision Quality: Decison Process Subscale |
5.66; 5.47; 4.57; 5.67; 5.02; 4.64 | 0.048 sig |
| PRIMARY Change in Decision Quality: Concordance Subscale |
95.3; 92.9; 95.4 | 0.46 |
| SECONDARY Number of Participants Who Chose Lumpectomy or Mastectomy as Their Treatment Choice |
42; 161; 146; 10; 39; 46 | — |
| SECONDARY Change in Quality of Life |
0.83; 0.82; 0.82; 0.82; 0.85; 0.82 | 0.25 |
| SECONDARY Anxiety |
20.8; 20.2; 20.7; 20.0; 20.4; 20.6 | 0.72 |
| SECONDARY Shared Decision-making (Self-reported) |
73; 76; 58 | 0.01 sig |
| SECONDARY Shared Decision-making (Observed) |
69.92; 65.72; 41.02 | <0.01 sig |
| SECONDARY Decision Regret |
10.9; 8.1; 12.9; 12.0; 7.6; 10.8 | 0.06 |
| SECONDARY Integration of Health Care Delivery |
10.4; 10.2; 10.3; 10.9; 10.8; 10.6 | 0.11 |
| SECONDARY Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination |
30; 29; 40; 30; 30; 15 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Assigned female at birth;
- 18 years and older;
- Confirmed diagnosis (via biopsy) of early stage breast cancer (stages I-IIIA);
- Eligible for both breast-conserving surgery and mastectomy based on medical records and clinician's opinion before surgery;
- Spoken English, Spanish, or Mandarin Chinese.
Exclusion Criteria
- Transgender men and women;
- Women who have undergone prophylactic mastectomy;
- Women with visual impairment;
- Women with a diagnosis of severe mental illness or severe dementia;
- Women with inflammatory breast carcinoma.
Data sourced from ClinicalTrials.gov (NCT03136367). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.