Trial reportCancer2021
What matters most: Randomized controlled trial of breast cancer surgery conversation aids across socioeconomic strata.
Trial report in Cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06076421 (Do Evidence-based Fact Boxes Improve Informed Decision-making About COVID-19 and Influenza Vaccination in More and Less Disadvantaged Groups Equally? - Study Protocol for a Multi-center Cluster RCT in Health and Social Care in Germany), which is not on this map. Cited by 45 papers, 6 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Do Evidence-based Fact Boxes Improve Informed Decision-making About COVID-19 and Influenza Vaccination in More and Less Disadvantaged Groups Equally? - Study Protocol for a Multi-center Cluster RCT in Health and Social Care in Germany
Who cites it
45 citing papers in PubMed, 6 syntheses or guidelines pooled it.
- Impact of Decision Aids for Shared Decision-Making for Patients with Early Stage Breast Cancer: A Systematic Review.Current oncology (Toronto, Ont.) · 2026Pooled it
- A mixed methods systematic review of cancer treatment decision-making in vulnerable populations.Patient education and counseling · 2026Pooled it
- Pooled it
- Effect of healthcare professional-delivered health literacy interventions on patient reported outcomes in cancer patients - a systematic review.BMC cancer · 2026Pooled it
- Effects of patient decision aids used pre-consult or in-consult on patient-clinician communication - secondary analysis of a systematic review with meta-analysis.BMC medical informatics and decision making · 2025Pooled it
- Decision aids for people facing health treatment or screening decisions.The Cochrane database of systematic reviews · 2024Pooled it
- Impact of a Web-Based Decision Aid on Socioeconomically Disadvantaged Patients' Engagement in Breast Surgery Decision-Making: Stepped-Wedge Clinical Trial (Alliance-A231701CD).Annals of surgical oncology · 2025Trial
- The UPFRONT project: tailored implementation and evaluation of a patient decision aid to support shared decision-making about management of symptomatic uterine fibroids.Implementation science : IS · 2024Trial
- The impact of adding cost information to a conversation aid to support shared decision making about low-risk prostate cancer treatment: Results of a stepped-wedge cluster randomised trial.Health expectations : an international journal of public participation in health care and health policy · 2023Trial
- Effect of patient decision aids on decisional conflict and regret associated with breast cancer surgery: a randomized controlled trial.Breast cancer (Tokyo, Japan) · 2022Trial
- Implementation and sustainability factors of two early-stage breast cancer conversation aids in diverse practices.Implementation science : IS · 2021Trial
- Trial
- Experiences and Decisional Outcomes After Cytoreductive Surgery for Peritoneal Surface Malignancy: The DECISIVE Study.Annals of surgical oncology · 2026Article
- Effectiveness of decision aids on decisional conflict and treatment or disease knowledge among women diagnosed with breast cancer: a systematic review and meta-analysis.Journal of cancer survivorship : research and practice · 2026Review
- Article
- Deciding on surveillance colonoscopy: a multi-phase study of a conversation aid for older adults.BMC medical informatics and decision making · 2026Article
- Article
- Shared decision-making for early-stage breast cancer treatment: An evolutionary concept analysis.Asia-Pacific journal of oncology nursing · 2025Review
- Decision Regret About Treatment Amongst Women With Early Breast Cancer: An Integrative Review.Journal of advanced nursing · 2025Review
- Health Literacy Applications in Patients With Cancer.Clinical journal of oncology nursing · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
30 authors.
Funding
Abstract
backgroundWomen of lower socioeconomic status (SES) with early-stage breast cancer are more likely to report poorer physician-patient communication, lower satisfaction with surgery, lower involvement in decision making, and higher decision regret compared to women of higher SES. The objective of this study was to understand how to support women across socioeconomic strata in making breast cancer surgery choices.
methodsWe conducted a 3-arm (Option Grid, Picture Option Grid, and usual care), multisite, randomized controlled superiority trial with surgeon-level randomization. The Option Grid (text only) and Picture Option Grid (pictures plus text) conversation aids were evidence-based summaries of available breast cancer surgery options on paper. Decision quality (primary outcome), treatment choice, treatment intention, shared decision making (SDM), anxiety, quality of life, decision regret, and coordination of care were measured from T0 (pre-consultation) to T5 (1-year after surgery.
resultsSixteen surgeons saw 571 of 622 consented patients. Patients in the Picture Option Grid arm (n = 248) had higher knowledge (immediately after the visit [T2] and 1 week after surgery or within 2 weeks of the first postoperative visit [T3]), an improved decision process (T2 and T3), lower decision regret (T3), and more SDM (observed and self-reported) compared to usual care (n = 257). Patients in the Option Grid arm (n = 66) had higher decision process scores (T2 and T3), better coordination of care (12 weeks after surgery or within 2 weeks of the second postoperative visit [T4]), and more observed SDM (during the surgical visit [T1]) compared to usual care arm. Subgroup analyses suggested that the Picture Option Grid had more impact among women of lower SES and health literacy. Neither intervention affected concordance, treatment choice, or anxiety.
conclusionsPaper-based conversation aids improved key outcomes over usual care. The Picture Option Grid had more impact among disadvantaged patients. LAY SUMMARY: The objective of this study was to understand how to help women with lower incomes or less formal education to make breast cancer surgery choices. Compared with usual care, a conversation aid with pictures and text led to higher knowledge. It improved the decision process and shared decision making (SDM) and lowered decision regret. A text-only conversation aid led to an improved decision process, more coordinated care, and higher SDM compared to usual care. The conversation aid with pictures was more helpful for women with lower income or less formal education. Conversation aids with pictures and text helped women make better breast cancer surgery choices.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.