Comparative Effectiveness of Encounter Decision Aids for Early-Stage Breast Cancer Across Socioeconomic Strata
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 571
- 试验地点
- 5
- 主要终点
- Change in Decision Quality: Knowledge Subscale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Data analysts will be blinded to the clinician randomization.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Option Grid (Other)
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.
干预措施: Picture Option Grid (Other)
Arm 3: Usual Care
In the usual care arm, surgeons provided their standard information about breast cancer
结局指标
主要结局
Change in Decision Quality: Knowledge Subscale
时间窗: 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: Decison Process Subscale
时间窗: 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: Concordance Subscale
时间窗: 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).
次要结局
- Decision Regret(At 1 week post-surgery, 12 weeks post-surgery, and 1 year post-surgery)
- Integration of Health Care Delivery(Immediately before the index surgical consultation visit and at 12 weeks post-surgery)
- Number of Participants Who Chose Lumpectomy or Mastectomy as Their Treatment Choice(1 week post-surgery)
- 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)
- Change in Quality of Life(Immediately before the index surgical consultation visit and at 12 weeks post-surgery)
- Shared Decision-making (Self-reported)(Immediately after the index surgical consultation visit)
- Shared Decision-making (Observed)(During the index surgical consultation visit)
- Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination(12 weeks post-surgery (patients) or after trial participation ended (surgeons))
研究者
Marie-Anne Durand
Principal Investigator
Dartmouth-Hitchcock Medical Center