An observational study in Stigma of Mental Illness, Cancer and Psychiatric Comorbidity, sponsored by Istituto Oncologico Veneto IRCCS. Not yet recruiting at 5 sites in Italy. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Istituto Oncologico Veneto IRCCS · Observational
ONCO-MinD is a multicentre, cross-sectional, non-interventional mixed-method study aimed at investigating healthcare providers' attitudes towards oncology patients with mental disorders in Italian cancer centres. The study will assess levels of mental health-related stigma among healthcare professionals and explore factors associated with these attitudes, including professional background, clinical setting, experience, and previous exposure to mental health conditions. Quantitative survey data collected using the Italian version of the Opening Minds Scale for Health Care Providers (OMS-HC) will be integrated with qualitative findings from semi-structured interviews to provide a comprehensive understanding of how stigma may influence clinical relationships, decision-making processes, and equity of cancer care.
Background People living with mental disorders experience substantial health inequalities, including reduced life expectancy and higher mortality rates from physical illnesses, including cancer. In oncology settings, evidence suggests that patients with mental disorders are less likely to receive guideline-concordant treatment, are more likely to experience delays in diagnosis, and often have lower treatment adherence. Multiple factors contribute to these disparities, including patient-related, organisational, and healthcare provider-related determinants.
Among healthcare provider-related factors, stigma towards people with mental disorders may influence communication, therapeutic relationships, treatment decisions, and access to appropriate care. One particularly relevant mechanism is diagnostic overshadowing, whereby physical symptoms may be misattributed to a patient's psychiatric condition, potentially resulting in delayed diagnosis and suboptimal management. Despite growing recognition of these issues, limited evidence is available regarding stigma among oncology healthcare professionals, particularly within the Italian context.
Study Objectives The primary objective is to evaluate the level of stigma among healthcare professionals towards oncology patients with mental disorders.
Secondary objectives are:
To identify associations between stigma levels and individual or professional characteristics, including years of experience, professional role, clinical area, education, and previous personal or professional exposure to mental health conditions.
To explore healthcare professionals' experiences, perceptions, and attitudes towards caring for oncology patients with mental disorders.
To investigate potential barriers affecting clinical interactions and care pathways, including the role of diagnostic overshadowing and other stigma-related mechanisms.
Study Design
ONCO-MinD is a multicentre, observational, cross-sectional, non-interventional study using a sequential explanatory mixed-method design. The study consists of two consecutive and integrated phases:
Phase 1: Quantitative Component
Eligible healthcare professionals working in participating oncology centres will be invited to complete an anonymous electronic questionnaire through a secure REDCap platform. The questionnaire includes:
Socio-demographic and professional characteristics. The Italian version of the Opening Minds Scale for Health Care Providers (OMS-HC), a validated instrument measuring stigma towards individuals with mental disorders.
The survey will remain available for approximately three months. Phase 2: Qualitative Component Following analysis of the quantitative findings, a purposive sample of healthcare professionals will be invited to participate in semi-structured interviews. Interviews will explore experiences, perceptions, barriers, facilitators, and the impact of mental health conditions on oncology care and clinical decision-making. Interviews will be audio-recorded, transcribed, anonymised, and analysed using thematic analysis.
Integration of Findings Quantitative and qualitative results will be integrated through a mixed-method approach using joint displays and meta-inferences. This strategy will allow a deeper understanding of the factors underlying stigma and its potential influence on cancer care delivery.
Study Population
The study population includes healthcare professionals directly involved in oncology care at participating centres, including:
Physicians Nurses Psychologists Radiation therapy technologists Healthcare assistants
All eligible professionals working within participating institutions will be invited to participate.
Participating Centres
Veneto Institute of Oncology (IOV-IRCCS), Padua, Italy Centro di Riferimento Oncologico (CRO-IRCCS), Aviano, Italy Istituto Tumori "Giovanni Paolo II" (IRCCS), Bari, Italy
Expected Impact The study is expected to generate evidence on mental health-related stigma in oncology settings and to identify educational and organisational strategies that may improve equity, inclusiveness, and quality of cancer care for patients living with mental disorders.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 200 across 2,638 observational studies indexed under Neoplasms.
Browse Neoplasms studies →Istituto Oncologico Veneto IRCCS is the lead sponsor of 47 studies on the registry; 13 are open to participants now.
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The study population consists of healthcare professionals working in oncology settings at participating Italian cancer centres. Eligible participants include physicians, nurses, psychologists, radiation therapy technologists, and healthcare assistants directly involved in the care of oncology patients. Participants will be recruited through exhaustive sampling across participating institutions and invited to complete an anonymous survey. A purposive sample of survey participants may subsequently be invited to participate in semi-structured interviews as part of the qualitative phase of the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For the qualitative phase, a purposive sample of participants will be selected from survey respondents who agree to be contacted for a semi-structured interview.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Physicians, nurses, psychologists, radiation therapy technologists, and healthcare assistants working in participating oncology centres.
Other: OMS-HC Questionnaire and Semi-Structured Interviews
Participants complete an anonymous questionnaire and, where selected, participate in a semi-structured interview for research data collection purposes. No clinical or behavioural intervention is administered.
Mental health-related stigma among oncology healthcare professionals
Level of stigma towards people with mental disorders measured using the Italian version of the Opening Minds Scale for Health Care Providers (OMS-HC). The total score ranges from 15 to 75, with higher scores indicating greater stigma and lower scores indicating more positive attitudes towards people with mental disorders.
Time frame: At survey completion (up to 3 months)
Factors Associated With OMS-HC Scores
Association between OMS-HC scores and healthcare professionals' socio-demographic and professional characteristics, including age, sex, professional role, education, clinical area, years of experience, previous mental health experience, and perceived mental health training.
Time frame: Up to 3 months
Healthcare professionals' experiences and perceptions regarding oncology patients with mental disorders
Qualitative themes identified through semi-structured interviews, including perceived barriers to care, diagnostic overshadowing, impact of psychiatric comorbidity on clinical decision-making, relational challenges, and facilitators to improve cancer care.
Time frame: Up to 9 months
Integrated mixed-method understanding of stigma towards oncology patients with mental disorders
Integration of quantitative survey findings and qualitative interview data through joint displays and meta-inferences to provide a comprehensive understanding of mental health-related stigma among oncology healthcare professionals, including its determinants, manifestations, and perceived impact on cancer care delivery and clinical decision-making.
Time frame: Up to 13 months
Plan to share: No — Due to the nature of the study and the need to protect participant confidentiality, individual participant data will not be shared. Results will be reported only in aggregated and anonymised form.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Istituto Oncologico Veneto IRCCS