Breast Cancer
Conditions
Keywords
encounter decision aids, shared decision making, socioeconomic status, disparities, decision quality
Brief 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.
Detailed description
Background and Significance Breast cancer is the most commonly diagnosed malignancy in women. Despite improvements in survival, women of low socioeconomic status (SES) diagnosed with early stage breast cancer: * Continue to experience poorer doctor-patient communication, lower satisfaction with surgery and decision making, and higher decision regret compared to women of higher SES; * Often play a passive role in decision making; * Are less likely to undergo breast-conserving surgery (BCS); * Are less likely to receive optimal care. Those differences are disparities that predominantly affect women of low SES with early stage breast cancer, irrespective of race or ethnicity. For early stage breast cancer, low SES is a stronger predictor of poorer outcomes, treatment received and death, than race or ethnicity. The investigators define low SES as a lower income, lower educational attainment, and uninsured or state-insured status Although BCS is the recommended treatment for early stage breast cancer (stages I to IIIA), research confirms equivalent survival between mastectomy and BCS. Both options are offered yet have distinct harms and benefits, valued differently by patients. The patient and stakeholder partners involved in this study have emphasized the critical importance of supporting women in making high quality breast cancer surgery decisions (good knowledge and alignment between the patient's choice, values and priorities) irrespective of SES and health literacy. Yet, research shows that women of low SES are not usually involved in an informed, patient-centered dialogue about surgery choice. There is no evidence that women of low SES have distinct preferences that explain a lower uptake of BCS and limited engagement in decision making. Further, communication strategies are not typically adapted to women of low SES and low health literacy. Most decision aids for breast cancer have been designed for highly literate audiences, with poor accessibility and readability. Simpler, shorter decision aids delivered in the clinical encounter (encounter decision aids) may be more beneficial to underserved patients, and could reduce disparities. It is critical to determine how to effectively support women of low SES in making informed breast cancer surgery choices. Study Aims First, the investigators will assess the comparative effectiveness of two effective encounter decision aids (Option Grid and Picture Option Grid) against usual care on decision quality (primary outcome), shared decision making, treatment choice and other secondary outcomes across socioeconomic strata (Aim 1). Second, the investigators aim to explore the effect of the Picture Option Grid on disparities in decision making (decision quality, knowledge, and shared decision making), treatment choice, as well as mediation and moderation effects (Aim 2). Third, in order to maximize the implementation potential, the investigators will explore strategies that promote the encounter decision aids' sustained use and dissemination using a theoretical implementation model (Aim 3). Study Description The investigators will conduct a three-arm, multi-site randomized controlled superiority trial with stratification by SES (Aims 1 and 2) and randomization at the clinician level. One thousand, one hundred patients (half of higher SES and half of lower SES) will be recruited from five large cancer centers. In preparation for the trial (Year 01), the investigators will conduct semi-structured interviews with women of low SES who have completed treatment for early stage breast cancer to adapt the What Matters Most to You subscale of the Decision Quality Instrument (DQI) for women of low SES. Lastly, the investigators will use interviews, field-notes, and observations to explore strategies that promote the interventions' sustained use and dissemination using the Normalization Process Theory (Aim 3). Community-Based Participatory Research will be used throughout the trial (with continuous patient and stakeholder involvement). Women 18 years and older with a confirmed diagnosis of early stage breast cancer (I to IIIA) from both higher and lower SES will be included in the trial, provided they have a basic command of English, Spanish, or Mandarin. About 367 patients will be recruited per arm. Both interventions have been developed, tested, and shown to be effective. The Option Grid (intervention 1) is a one-page evidence-based summary of available options presented in a tabular format, listing the trade-offs that patients normally consider when making breast cancer surgery decisions. The Picture Option Grid (intervention 2) uses the same evidence and tabular layout, but it is tailored to women of lower SES and low health literacy and includes simple text and images. Because decision aids are not routinely available in real world settings, usual care is a coherent and legitimate comparator. It will include the provision of usual information resources about breast cancer but will exclude the provision of other decision aids. Secondary outcome measures will include treatment choice, the validated 3-item CollaboRATE measure of shared decision-making (SDM), Chew's validated one-item health literacy screening question, PROMIS, an 8-item validated anxiety short form, EQ-5D-5L, a validated, standardized 6-item quality of life measure, and four items from COST, a validated financial toxicity measure. Participants will also be asked to estimate their out-of-pocket expenses over the past month. All measures will be available in English, Spanish, and Mandarin. Observer OPTION5 will be used to rate the level of shared decision making in the clinical encounter. A regression framework (logistic regression, linear regression, mixed effect regression models, generalized estimating equations) and mediation analyses will be used in the analysis. The investigators will also use multiple informants analysis to measure and examine SES and multiple imputation to manage missing data. Heterogeneity of treatment effects analyses for SES, age, ethnicity, race, literacy, language, and study site will be performed. The investigators will also use the recordings of surgical consultations to analyze the conversations about costs and treatment recommendations made by providers.
Interventions
OTHEROption 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.
OTHERPicture 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.
Sponsors
Washington University School of Medicine
Montefiore Medical Center
NYU Langone Health
Patient-Centered Outcomes Research Institute
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
Data analysts will be blinded to the clinician randomization.
Intervention model description
Three-arm randomized controlled superiority trial with stratification by SES and randomization at the clinician level. Patient enrollment will occur at five cancer centers in the United States. Patients will be enrolled in one of the three arms based on the clinician they are seeing as a part of their care.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Decision Quality: Decison Process Subscale | 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 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. |
| Change in Decision Quality: Knowledge Subscale | 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 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. |
| Change in Decision Quality: Concordance Subscale | 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 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life | 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. |
| Anxiety | 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. |
| Shared Decision-making (Self-reported) | 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. |
| Shared Decision-making (Observed) | 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 score ranging from zero to 100. Higher numbers indicate more shared decision making was observed. |
| Decision Regret | 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. |
| Integration of Health Care Delivery | 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. |
| Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination | 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 |
| Number of Participants Who Chose Lumpectomy or Mastectomy as Their Treatment Choice | 1 week post-surgery | Treatment choice, or which surgical or treatment option the patient chose, mastectomy or lumpectomy (breast conserving surgery) |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 69 |
| 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. | 276 |
| Arm 3: Usual Care In the usual care arm, surgeons provided their standard information about breast cancer | 271 |
| Total | 616 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| T1 Consultation | discontinued mistakenly included | 2 | 6 | 1 |
| T1 Consultation | Discontinued other | 0 | 1 | 0 |
| T2 Post-consultation | Discontinued lost contact | 0 | 1 | 0 |
| 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 | Withdrawal by Subject | 1 | 1 | 5 |
| T3 1 Week After Surgery | Discontinued lost contact | 1 | 2 | 4 |
| 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 |
| 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 mistakenly included | 0 | 0 | 1 |
| T4 12 Weeks After Surgery | discontinued transferred care | 0 | 1 | 5 |
| T4 12 Weeks After Surgery | Withdrawal by Subject | 1 | 3 | 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 | discontinued mistakenly included | 1 | 1 | 1 |
| T5 1 Year After Surgery | logistical issues prevented contact | 0 | 4 | 2 |
| 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 | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Arm 1: Option Grid | Arm 2: Picture Option Grid | Arm 3: Usual Care | Total |
|---|---|---|---|---|
| Age, Continuous | 60.1 years STANDARD_DEVIATION 11.5 | 58.9 years STANDARD_DEVIATION 13 | 60.4 years STANDARD_DEVIATION 12.2 | 59.7 years STANDARD_DEVIATION 12.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 13 Participants | 4 Participants | 19 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 37 Participants | 40 Participants | 96 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 4 Participants | 8 Participants | 13 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 11 Participants | 16 Participants |
| Race (NIH/OMB) White | 46 Participants | 218 Participants | 208 Participants | 472 Participants |
| Sex: Female, Male Female | 69 Participants | 276 Participants | 271 Participants | 616 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 66 | 1 / 248 | 4 / 257 |
| other Total, other adverse events | 0 / 66 | 0 / 248 | 0 / 257 |
| serious Total, serious adverse events | 0 / 66 | 0 / 248 | 0 / 257 |
Outcome results
Primary
Change in Decision Quality: Concordance Subscale
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).
Time frame: Immediately after the index surgical consultation visit and at one week post-surgery
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: Option Grid | Change in Decision Quality: Concordance Subscale | 95.3 percentage with treatment match |
| Arm 2: Picture Option Grid | Change in Decision Quality: Concordance Subscale | 92.9 percentage with treatment match |
| Arm 3: Usual Care | Change in Decision Quality: Concordance Subscale | 95.4 percentage with treatment match |
p-value: 0.46Mixed Models Analysis
p-value: 0.34Mixed Models Analysis
p-value: 0.165Mixed Models Analysis
Primary
Change in Decision Quality: Decison Process Subscale
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 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.
Time frame: Immediately after the index surgical consultation visit and at one week post-surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Option Grid | Change in Decision Quality: Decison Process Subscale | Immediately after the index surgical consultation visit | 5.66 score on a scale | Standard Deviation 1.24 |
| Arm 1: Option Grid | Change in Decision Quality: Decison Process Subscale | One week post-surgery | 5.67 score on a scale | Standard Deviation 1.26 |
| Arm 2: Picture Option Grid | Change in Decision Quality: Decison Process Subscale | Immediately after the index surgical consultation visit | 5.47 score on a scale | Standard Deviation 1.58 |
| Arm 2: Picture Option Grid | Change in Decision Quality: Decison Process Subscale | One week post-surgery | 5.02 score on a scale | Standard Deviation 1.73 |
| Arm 3: Usual Care | Change in Decision Quality: Decison Process Subscale | Immediately after the index surgical consultation visit | 4.57 score on a scale | Standard Deviation 2.1 |
| Arm 3: Usual Care | Change in Decision Quality: Decison Process Subscale | One week post-surgery | 4.64 score on a scale | Standard Deviation 1.95 |
p-value: 0.048Mixed Models Analysis
p-value: 0.015Mixed Models Analysis
p-value: 0.43Mixed Models Analysis
Primary
Change in Decision Quality: Knowledge Subscale
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.
Time frame: Immediately before the index surgical consultation visit, immediately after the index surgical consultation visit and at one week post-surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Option Grid | Change in Decision Quality: Knowledge Subscale | Immediately before the index surgical consultation visit | 2.83 score on a scale | Standard Deviation 1.29 |
| Arm 1: Option Grid | Change in Decision Quality: Knowledge Subscale | One week post-surgery | 3.00 score on a scale | Standard Deviation 1.11 |
| Arm 1: Option Grid | Change in Decision Quality: Knowledge Subscale | Immediately after the index surgical consultation visit | 2.82 score on a scale | Standard Deviation 1.13 |
| Arm 2: Picture Option Grid | Change in Decision Quality: Knowledge Subscale | Immediately before the index surgical consultation visit | 2.95 score on a scale | Standard Deviation 1.22 |
| Arm 2: Picture Option Grid | Change in Decision Quality: Knowledge Subscale | Immediately after the index surgical consultation visit | 2.90 score on a scale | Standard Deviation 1.07 |
| Arm 2: Picture Option Grid | Change in Decision Quality: Knowledge Subscale | One week post-surgery | 2.88 score on a scale | Standard Deviation 1.05 |
| Arm 3: Usual Care | Change in Decision Quality: Knowledge Subscale | One week post-surgery | 2.87 score on a scale | Standard Deviation 1.12 |
| Arm 3: Usual Care | Change in Decision Quality: Knowledge Subscale | Immediately after the index surgical consultation visit | 2.74 score on a scale | Standard Deviation 1.07 |
| Arm 3: Usual Care | Change in Decision Quality: Knowledge Subscale | Immediately before the index surgical consultation visit | 2.77 score on a scale | Standard Deviation 1.21 |
p-value: 0.045Mixed Models Analysis
p-value: 0.2Mixed Models Analysis
p-value: 0.82Mixed Models Analysis
Secondary
Anxiety
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Option Grid | Anxiety | 1 week post-surgery | 17.2 score on a scale | Standard Deviation 7.3 |
| Arm 1: Option Grid | Anxiety | 12 weeks post-surgery | 13.1 score on a scale | Standard Deviation 6.5 |
| Arm 1: Option Grid | Anxiety | Immediately before the index surgical consultation visit | 20.8 score on a scale | Standard Deviation 6.8 |
| Arm 1: Option Grid | Anxiety | immediately after the index surgical consultation visit | 20.0 score on a scale | Standard Deviation 6.7 |
| Arm 2: Picture Option Grid | Anxiety | 1 week post-surgery | 17.0 score on a scale | Standard Deviation 7.1 |
| Arm 2: Picture Option Grid | Anxiety | 12 weeks post-surgery | 13.0 score on a scale | Standard Deviation 5.6 |
| Arm 2: Picture Option Grid | Anxiety | immediately after the index surgical consultation visit | 20.4 score on a scale | Standard Deviation 8.1 |
| Arm 2: Picture Option Grid | Anxiety | Immediately before the index surgical consultation visit | 20.2 score on a scale | Standard Deviation 7.4 |
| Arm 3: Usual Care | Anxiety | 12 weeks post-surgery | 14.9 score on a scale | Standard Deviation 6.9 |
| Arm 3: Usual Care | Anxiety | Immediately before the index surgical consultation visit | 20.7 score on a scale | Standard Deviation 7.7 |
| Arm 3: Usual Care | Anxiety | immediately after the index surgical consultation visit | 20.6 score on a scale | Standard Deviation 7.9 |
| Arm 3: Usual Care | Anxiety | 1 week post-surgery | 17.1 score on a scale | Standard Deviation 6.7 |
p-value: 0.72Mixed Models Analysis
p-value: 0.41McNemar
p-value: 0.28Mixed Models Analysis
Secondary
Change in Quality of Life
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.
Time frame: Immediately before the index surgical consultation visit and at 12 weeks post-surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Option Grid | Change in Quality of Life | Immediately before the index surgical consultation visit | 0.83 score on a scale | Standard Deviation 0.13 |
| Arm 1: Option Grid | Change in Quality of Life | 12 weeks post-surgery | 0.82 score on a scale | Standard Deviation 0.1 |
| Arm 2: Picture Option Grid | Change in Quality of Life | Immediately before the index surgical consultation visit | 0.82 score on a scale | Standard Deviation 0.13 |
| Arm 2: Picture Option Grid | Change in Quality of Life | 12 weeks post-surgery | 0.85 score on a scale | Standard Deviation 0.13 |
| Arm 3: Usual Care | Change in Quality of Life | Immediately before the index surgical consultation visit | 0.82 score on a scale | Standard Deviation 0.14 |
| Arm 3: Usual Care | Change in Quality of Life | 12 weeks post-surgery | 0.82 score on a scale | Standard Deviation 0.12 |
p-value: 0.25Mixed Models Analysis
p-value: 0.89Mixed Models Analysis
p-value: 0.54Mixed Models Analysis
Secondary
Decision Regret
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.
Time frame: At 1 week post-surgery, 12 weeks post-surgery, and 1 year post-surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Option Grid | Decision Regret | 1 week post-surgery | 10.9 score on a scale | Standard Deviation 13.9 |
| Arm 1: Option Grid | Decision Regret | 1 year post-surgery | 10.4 score on a scale | Standard Deviation 14.1 |
| Arm 1: Option Grid | Decision Regret | 12 weeks post-surgery | 12.0 score on a scale | Standard Deviation 15.9 |
| Arm 2: Picture Option Grid | Decision Regret | 12 weeks post-surgery | 7.6 score on a scale | Standard Deviation 12.3 |
| Arm 2: Picture Option Grid | Decision Regret | 1 week post-surgery | 8.1 score on a scale | Standard Deviation 12.3 |
| Arm 2: Picture Option Grid | Decision Regret | 1 year post-surgery | 6.0 score on a scale | Standard Deviation 10.3 |
| Arm 3: Usual Care | Decision Regret | 1 week post-surgery | 12.9 score on a scale | Standard Deviation 14.5 |
| Arm 3: Usual Care | Decision Regret | 1 year post-surgery | 7.6 score on a scale | Standard Deviation 14.3 |
| Arm 3: Usual Care | Decision Regret | 12 weeks post-surgery | 10.8 score on a scale | Standard Deviation 16.2 |
p-value: 0.06Mixed Models Analysis
p-value: 0.65Mixed Models Analysis
p-value: 0.36Mixed Models Analysis
Secondary
Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination
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
Time frame: 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).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Arm 1: Option Grid | Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination | Patients | Open to receiving/giving aid before appointment | 15 Participants |
| Arm 1: Option Grid | Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination | Patients | Aid would be helpful for lower literacy patients | NA Participants |
| Arm 1: Option Grid | Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination | Patients | Aid affected treatment decision | 30 Participants |
| Arm 1: Option Grid | Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination | Patients | Aid was part of normal routine | 29 Participants |
| Arm 1: Option Grid | Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination | Patients | Want paper-based materials | 40 Participants |
| Arm 1: Option Grid | Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination | Patients | Thought receiving aid from the surgeon is best | 30 Participants |
| Arm 1: Option Grid | Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination | Patients | Open to receiving the aid in virtual formats | 30 Participants |
| Arm 1: Option Grid | Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination | Patients | Recommended other health professionals use the aid | NA Participants |
| Arm 1: Option Grid | Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination | Patients | Were able to integrate the aid into their routine | NA Participants |
| Arm 2: Picture Option Grid | Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination | All trial surgeons | Aid affected treatment decision | NA Participants |
| Arm 2: Picture Option Grid | Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination | All trial surgeons | Aid was part of normal routine | NA Participants |
| Arm 2: Picture Option Grid | Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination | All trial surgeons | Want paper-based materials | NA Participants |
| Arm 2: Picture Option Grid | Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination | All trial surgeons | Thought receiving aid from the surgeon is best | NA Participants |
| Arm 2: Picture Option Grid | Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination | All trial surgeons | Open to receiving the aid in virtual formats | NA Participants |
| Arm 2: Picture Option Grid | Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination | All trial surgeons | Open to receiving/giving aid before appointment | 8 Participants |
| Arm 2: Picture Option Grid | Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination | All trial surgeons | Aid would be helpful for lower literacy patients | NA Participants |
| Arm 2: Picture Option Grid | Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination | All trial surgeons | Recommended other health professionals use the aid | 16 Participants |
| Arm 2: Picture Option Grid | 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 |
| Arm 2: Picture Option Grid | Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination | Intervention surgeons | Aid affected treatment decision | NA Participants |
| Arm 2: Picture Option Grid | Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination | Intervention surgeons | Aid was part of normal routine | NA Participants |
| Arm 2: Picture Option Grid | Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination | Intervention surgeons | Want paper-based materials | NA Participants |
| Arm 2: Picture Option Grid | Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination | Intervention surgeons | Thought receiving aid from the surgeon is best | NA Participants |
| Arm 2: Picture Option Grid | Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination | Intervention surgeons | Open to receiving the aid in virtual formats | NA Participants |
| Arm 2: Picture Option Grid | Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination | Intervention surgeons | Open to receiving/giving aid before appointment | NA Participants |
| Arm 2: Picture Option Grid | Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination | Intervention surgeons | Aid would be helpful for lower literacy patients | 6 Participants |
| Arm 2: Picture Option Grid | Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination | Intervention surgeons | Recommended other health professionals use the aid | NA Participants |
| Arm 2: Picture Option Grid | Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination | Intervention surgeons | Were able to integrate the aid into their routine | 8 Participants |
Secondary
Integration of Health Care Delivery
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.
Time frame: Immediately before the index surgical consultation visit and at 12 weeks post-surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Option Grid | Integration of Health Care Delivery | Immediately before the index surgical consultation visit | 10.4 score on a scale | Standard Deviation 1.8 |
| Arm 1: Option Grid | Integration of Health Care Delivery | 12 weeks post-surgery | 10.9 score on a scale | Standard Deviation 1.1 |
| Arm 2: Picture Option Grid | Integration of Health Care Delivery | Immediately before the index surgical consultation visit | 10.2 score on a scale | Standard Deviation 2 |
| Arm 2: Picture Option Grid | Integration of Health Care Delivery | 12 weeks post-surgery | 10.8 score on a scale | Standard Deviation 1.5 |
| Arm 3: Usual Care | Integration of Health Care Delivery | Immediately before the index surgical consultation visit | 10.3 score on a scale | Standard Deviation 1.9 |
| Arm 3: Usual Care | Integration of Health Care Delivery | 12 weeks post-surgery | 10.6 score on a scale | Standard Deviation 1.8 |
p-value: 0.11Mixed Models Analysis
p-value: 0.037Mixed Models Analysis
p-value: 0.28Mixed Models Analysis
Secondary
Number of Participants Who Chose Lumpectomy or Mastectomy as Their Treatment Choice
Treatment choice, or which surgical or treatment option the patient chose, mastectomy or lumpectomy (breast conserving surgery)
Time frame: 1 week post-surgery
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1: Option Grid | Number of Participants Who Chose Lumpectomy or Mastectomy as Their Treatment Choice | lumpectomy | 42 Participants |
| Arm 1: Option Grid | Number of Participants Who Chose Lumpectomy or Mastectomy as Their Treatment Choice | mastectomy | 10 Participants |
| Arm 2: Picture Option Grid | Number of Participants Who Chose Lumpectomy or Mastectomy as Their Treatment Choice | lumpectomy | 161 Participants |
| Arm 2: Picture Option Grid | Number of Participants Who Chose Lumpectomy or Mastectomy as Their Treatment Choice | mastectomy | 39 Participants |
| Arm 3: Usual Care | Number of Participants Who Chose Lumpectomy or Mastectomy as Their Treatment Choice | lumpectomy | 146 Participants |
| Arm 3: Usual Care | Number of Participants Who Chose Lumpectomy or Mastectomy as Their Treatment Choice | mastectomy | 46 Participants |
Secondary
Shared Decision-making (Observed)
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 score ranging from zero to 100. Higher numbers indicate more shared decision making was observed.
Time frame: During the index surgical consultation visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1: Option Grid | Shared Decision-making (Observed) | 69.92 score on a scale |
| Arm 2: Picture Option Grid | Shared Decision-making (Observed) | 65.72 score on a scale |
| Arm 3: Usual Care | Shared Decision-making (Observed) | 41.02 score on a scale |
p-value: <0.01Mixed Models Analysis
p-value: <0.01Mixed Models Analysis
Secondary
Shared Decision-making (Self-reported)
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.
Time frame: Immediately after the index surgical consultation visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: Option Grid | Shared Decision-making (Self-reported) | 73 percentage of patients with a top score |
| Arm 2: Picture Option Grid | Shared Decision-making (Self-reported) | 76 percentage of patients with a top score |
| Arm 3: Usual Care | Shared Decision-making (Self-reported) | 58 percentage of patients with a top score |
p-value: 0.01Mixed Models Analysis
p-value: 0.12Mixed Models Analysis
p-value: 0.78Mixed Models Analysis