Evidence map›Paper›PMID 42831611›Full record

Observational studyPsycho-oncology2026

From Clinical Reality to Blueprint Designing: A Qualitative Study Exploring Communication Challenges and Unmet Needs for Patient Decision Aid Development in Early-Stage Breast Cancer.

Serena Sdinami, Martina Maialetti, Valeria Sebri, Paola Zagami, Roberto Grasso, Giuseppe Curigliano, Gabriella Pravettoni

Registry-linked trialAbstract readObservational Study
In one paragraph

Observational study in Psycho-oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06762496 (Development and Testing of a Patient's Decision Aid for Early Breast Cancer), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT06762496 recruitingnot on this map

Development and Testing of a Patient's Decision Aid for Early Breast Cancer: a New Tool to Promote Patient's Engagement in Their Healthcare Process

TypeobservationalSponsorEuropean Institute of OncologyRan2025 to 2027Enrolled180ConditionsBreast Carcinoma, Breast Cancer Stage I, Breast Cancer Stage IIArmsHealthcare professionals, Patients PDA group, Patients control group
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Serena SdinamiApplied Research Division for Cognitive and Psychological Science, European Institute of Oncology IRCCS, Milan, Italy.ORCID https://orcid.org/0009-0008-0058-2641
Martina MaialettiDivision for New Drugs and Early Drugs Development for Innovative Therapies, European Institute of Oncology IRCCS, Milan, Italy.
Valeria SebriApplied Research Division for Cognitive and Psychological Science, European Institute of Oncology IRCCS, Milan, Italy.ORCID https://orcid.org/0000-0002-1227-7336
Paola ZagamiDivision for New Drugs and Early Drugs Development for Innovative Therapies, European Institute of Oncology IRCCS, Milan, Italy.ORCID https://orcid.org/0000-0002-2687-6436
Roberto GrassoApplied Research Division for Cognitive and Psychological Science, European Institute of Oncology IRCCS, Milan, Italy.
Giuseppe CuriglianoDivision for New Drugs and Early Drugs Development for Innovative Therapies, European Institute of Oncology IRCCS, Milan, Italy.ORCID https://orcid.org/0000-0003-1781-2518
Gabriella PravettoniApplied Research Division for Cognitive and Psychological Science, European Institute of Oncology IRCCS, Milan, Italy.ORCID https://orcid.org/0000-0002-4843-4663

Funding

Eli Lilly and Company A-36495
6 · The paper itself

Abstract

introductionA diagnosis of early-stage Breast Cancer (BC) induces significant psychological distress in patients, who are then required to make complex treatment decisions. Evidence-based tools like Patient Decision Aids (PDAs) have been proposed as tools to support communication and Shared Decision-Making (SDM). However, their successful use in clinical practice depends also on real-world consultation dynamics. Existing literature suggests that insufficient attention to contextual and user-centered factors may limit the relevance and uptake of PDAs. A bottom-up approach grounded in clinical reality may therefore be essential to inform their design and future integration into care.

aimsThis study aimed to explore experiences, unmet needs and expectations of both patients and healthcare professionals involved in early-stage breast cancer care regarding decision-making support and standard oncological consultations, in order to identify patient- and clinician-derived design requirements for a future PDA supporting shared treatment decision-making in early-stage breast cancer. METHODOLOGY: We conducted 52 semi-structured interviews with 20 patients and 32 HCPs at the European Institute of Oncology in Milan from 10 January 2025 to 30 August 2025. Interviews were transcribed and analyzed using thematic analysis, with coding performed by two independent researchers and discrepancies resolved through independent discussion with two other authors.

resultsHCPs highlighted three key themes: variability in patient information needs, misconceptions about treatments (especially chemotherapy and radiotherapy), and the multifactorial nature of treatment decisions. Patients emphasized the importance of trust in physicians, the need for practical information on side effects and coping strategies, and the role of peer support, often found through informal networks or social media. These findings identified preliminary requirements for a future PDA: adaptable information depth and timing; plain-language responses to common misconceptions; structured values-clarification prompts; practical preparation and side-effect-management information; signposting to vetted psychosocial and peer-support resources.

conclusionsFindings highlight communication challenges and unmet psychosocial and informational needs within standard oncological consultations for early-stage breast cancer. By grounding decision support development in the perspectives of both patients and healthcare professionals, this study provides formative, pre-implementation insights to guide the design of PDAs that are responsive to real-world clinical contexts and patient experiences.

trial registrationclinicaltrials.gov, identifier: NCT06762496. Registered 7th January 2025 -https://clinicaltrials.gov/study/NCT06762496.

Indexed as

Breast NeoplasmsCommunicationDecision Making, SharedDecision Support TechniquesPatient ParticipationAdultAgedDecision MakingFemaleHumansMiddle AgedNeoplasm StagingPhysician-Patient RelationsQualitative Researchearly‐stage breast cancerhealthcarehealthcare professionals needspatient decision aidpatient‐doctor communicationpatients needspsychosocial interventionshared decision‐making

Identifiers

PMID42831611
PMCPMC13637059

What OpenQuestion holds

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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.