Stigma of Mental IllnessONCO-MinDNCT07748221
Healthcare Providers' Attitudes Toward Oncology Patients With Mental Disorders
An observational study of Stigma of Mental Illness and Cancer, run by Istituto Oncologico Veneto IRCCS at 5 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stigma of Mental Illness, Cancer, Psychiatric Comorbidity
- What is being tested?
- OMS-HC Questionnaire and Semi-Structured Interviews
- How many people
- 1,000 participants
- Where
- 5 sitesItaly
- Study dates
- 1 Nov 2026to 31 Mar 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- Healthcare professionals working in participating oncology centres.
- Physicians, nurses, psychologists, radiation therapy technologists, and healthcare assistants.
- Direct involvement in the clinical care of oncology patients.
- Employed at one of the participating study sites at the time of enrolment.
- Able to understand the study information and provide informed consent.
- Willing to participate in the study.
- 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.
Who cannot join
- Refusal to participate or failure to provide informed consent.
- Students in training.
- Healthcare personnel working in services with very limited patient contact and without direct responsibility for oncology patient care.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Italy5 sites
Centro Riferimento Oncologico CRO IRCCS
Aviano, 33081
Lucia Cadorin, MSN, +39 434 659111, lcadorin@cro.it
Istituto Tumori IRCCS Giovanni Paolo II
Bari, 70124
Giuseppe Colonna, MSN, +39 80 555 5111, g.colonna@oncologico.bari.it
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola, Fo, 47014
Anita Zeneli, Master in Nursing, +39 0543 739100, anita.zeneli@irst.emr.it
Anita Zeneli, MSN, +39 0543 739100, anita.zeneli@irst.emr.it
The Padua, Castelfranco Veneto, and Schiavonia campuses of the Veneto Institute of Oncology (IOV-IRCCS).
Padova, 35128
Carlo Alberto Camuccio, MSN; MSC, + 39 3336173150, alberto.camuccio@iov.veneto.it
Elena Reginato, MSN, elena.reginato@iov.veneto.it
Centro di Riferimento Oncologico della Basilicata (CROB), Rionero in Vulture, Italy
Rionero in Vulture, Potenza, 85028
Emanuela Zifarone, MSN, +39 0972 726111, emanuela.zifarone@crob.it
About this study
Official title: Healthcare Providers' Attitudes Toward Oncology Patients With Mental Disorders: A Multicentre Mixed-Method Design Study
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.
Read the detailed description
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.
- Conditions
- Stigma of Mental Illness, Cancer, Psychiatric Comorbidity
- Being tested
- OMS-HC Questionnaire and Semi-Structured Interviews
- Keywords
- oncology, cancer, mental health, stigma, psychiatric comorbidity, oncology healthcare professionals
- Medical subject headings
- Neoplasms, Psychological Well-Being, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMS-HC Questionnaire and Semi-Structured InterviewsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Oncology Healthcare Professionals | Physicians, nurses, psychologists, radiation therapy technologists, and healthcare assistants working in participating oncology centres. Receives: Other: OMS-HC Questionnaire and Semi-Structured Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At survey completion (up to 3 months)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Up to 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Stigma of Mental IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Oncologico Veneto IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- Centro di Riferimento Oncologico - Aviano, Istituti Tumori Giovanni Paolo II, Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS, IRCCS Centro di Riferimento Oncologico della Basilicata
- Responsible party
- Sponsor
- Investigators
- Carlo Alberto Camuccio, MSN; MSC, Principal investigator, Istituto Oncologico Veneto - IOV IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748221
- Sponsor's protocol ID
- ONCO-MinD
- Acronym
- ONCO-MinD
- Status last verified
- Sep 2026
- First submitted
- 23 Jul 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Destrebecq A, Ferrara P, Frattini L, Pittella F, Rossano G, Striano G, Terzoni S, Gambini O. The Italian Version of the Opening Minds Stigma Scale for Healthcare Providers: Validation and Study on a Sample of Bachelor Students. Community Ment Health J. 2018 Jan;54(1):66-72. doi: 10.1007/s10597-017-0149-0. Epub 2017 Jun 24.
PubMed 28647819Pasere E, O'Hara D, Ballard E, Kilgour C, Holland L. A narrative review of medical and surgical nurses' attitudes and perceptions when caring for patients with a secondary diagnosis of mental illness. Nurse Educ Today. 2025 Aug;151:106684. doi: 10.1016/j.nedt.2025.106684. Epub 2025 Mar 20.
PubMed 40168912Kisely S, Sadek J, MacKenzie A, Lawrence D, Campbell LA. Excess cancer mortality in psychiatric patients. Can J Psychiatry. 2008 Nov;53(11):753-61. doi: 10.1177/070674370805301107.
PubMed 19087469Ivankova, N. V., Creswell, J. W., & Stick, S. L. (2006). Using mixed-methods sequential explanatory design: From theory to practice. Field methods, 18(1),
Giandinoto JA, Stephenson J, Edward KL. General hospital health professionals' attitudes and perceived dangerousness towards patients with comorbid mental and physical health conditions: Systematic review and meta-analysis. Int J Ment Health Nurs. 2018 Jun;27(3):942-955. doi: 10.1111/inm.12433. Epub 2018 Feb 5.
PubMed 29399940Firth J, Siddiqi N, Koyanagi A, Siskind D, Rosenbaum S, Galletly C, Allan S, Caneo C, Carney R, Carvalho AF, Chatterton ML, Correll CU, Curtis J, Gaughran F, Heald A, Hoare E, Jackson SE, Kisely S, Lovell K, Maj M, McGorry PD, Mihalopoulos C, Myles H, O'Donoghue B, Pillinger T, Sarris J, Schuch FB, Shiers D, Smith L, Solmi M, Suetani S, Taylor J, Teasdale SB, Thornicroft G, Torous J, Usherwood T, Vancampfort D, Veronese N, Ward PB, Yung AR, Killackey E, Stubbs B. The Lancet Psychiatry Commission: a blueprint for protecting physical health in people with mental illness. Lancet Psychiatry. 2019 Aug;6(8):675-712. doi: 10.1016/S2215-0366(19)30132-4. Epub 2019 Jul 16. No abstract available.
PubMed 31324560Elliott K, Haworth E, Bolnykh I, McAllister-Williams RH, Greystoke A, Todd A, Sharp L. Breast cancer patients with a pre-existing mental illness are less likely to receive guideline-recommended cancer treatment: A systematic review and meta-analysis. Breast. 2025 Feb;79:103855. doi: 10.1016/j.breast.2024.103855. Epub 2024 Dec 7.
PubMed 39708443Creswell JW, Inoue M. A process for conducting mixed methods data analysis. J Gen Fam Med. 2024 Oct 3;26(1):4-11. doi: 10.1002/jgf2.736. eCollection 2025 Jan.
PubMed 39776872Charlesworth L, Fegan C, Ashmore R. How does severe mental illness impact on cancer outcomes in individuals with severe mental illness and cancer? A scoping review of the literature. J Med Imaging Radiat Sci. 2023 Jun;54(2S):S104-S114. doi: 10.1016/j.jmir.2023.01.007. Epub 2023 Feb 15.
PubMed 36804013