CancerSurvivorshipNCT06236373
The Unmet Needs of Cancer Survivors in Ausl IRCCS Reggio Emilia
An observational study of Cancer and Breast Cancer, run by University of Modena and Reggio Emilia at 1 site in Italy.
Trial summary
This qualitative study seeks to explore the unmet needs of individuals who have recently undergone a cancer diagnosis and completed the acute phase of treatment. The primary objective is to utilize the experiences of patients, caregivers, and stakeholders to enhance the aftercare provided to cancer survivors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Breast Cancer, Prostate Cancer
- What is being tested?
- Focus Groups or Interviews
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- 20 Apr 2023to Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer survivors who have recived a diagnosis of the following types of cancer: * breast, * prostate, * thyroid, * colorectal, * multiple myeloma * lymphoma Or caregiver/stakeholder of an individual who meets the inclusion criteria and are aged 18 years or over
Who may be able to join
- Adult aged18 years or over.
- Individuals who have a history of breast, prostate, thyroid, colorectal, multiple myeloma or lymphoma cancer within the past years who have completed the acute phase of treatment, and are in follow-up or are receiving maintenance treatment;
- Caregivers for an individual who meets the above criteria, who are aged 18 years or over.
- Stakeholders for individual who meets the above criteria, who are aged 18 years or over.
Who cannot join
- Individuals who do not wish to participate
- Individuals who do not understand and/or speak Italian
- Individuals with significant cognitive impairment, learning difficulty, or communication difficulty such that understanding the nature of the study, the interview questions, or participating in a focus group or an on-line or in-presence interview would not be practical.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Casa della Salute ex Spallanzani
Reggio Emilia, Reggio Emilia, 42123
Angela Contri, MA, +393478824741, angela.contri@unimore.it
angela.contri@libero.it
About this study
Official title: The Unmet Needs of Cancer Survivors in Ausl IRCCS Reggio Emilia Reality: a Qualitative Study and Framework Analysis
This qualitative study seeks to explore the unmet needs of individuals who have recently undergone a cancer diagnosis and completed the acute phase of treatment. The primary objective is to utilize the experiences of patients, caregivers, and stakeholders to enhance the aftercare provided to cancer survivors. By delving into patient perceptions regarding unmet needs in cancer aftercare, the study aims to identify areas for redesigning and improving services to minimize these needs and ultimately enhance patient outcomes. Importantly, the investigation incorporates insights from patients, their caregivers, and stakeholders.
The research will employ qualitative methods, specifically focus groups and interviews, to gather comprehensive perspectives from individuals in the Ausl IRCCS Reggio Emilia district who have completed treatment for breast, prostate, colorectal, thyroid, and multiple myeloma cancers. Including patients with diverse cancer types is crucial for capturing a broad spectrum of experiences.
Read more
During data collection, both focus group discussions and interviews will be recorded in audio format and transcribed verbatim. This meticulous approach ensures an accurate representation of participants' voices and experiences. The subsequent analysis will employ a combination of framework and thematic analysis to extract meaningful insights and synthesize the data effectively.
The study's ultimate goal is to leverage the findings to optimize aftercare services for cancer survivors within the local context of Ausl IRCCS Reggio Emilia. By incorporating the perspectives of patients, caregivers, and stakeholders, the research aims to contribute valuable insights that can inform the redesign and improvement of aftercare services, ultimately benefitting cancer survivors in the region.
Read the detailed description
The escalating global population of cancer survivors (CSs) underscores the imperative to offer services tailored to address their specific unmet needs. Individuals are designated as 'cancer survivors' from the moment of diagnosis onward throughout their lifetime. Despite this, there is a worldwide acknowledgment that CSs encounter a spectrum of physical, psychosocial, spiritual, informational, and practical challenges, often leading to unmet needs that frequently go unrecognized and unaddressed.
Unmet needs, in this context, refer to those requirements perceived by individuals as lacking the necessary level of service for achieving optimal well-being. These can be characterized as unsatisfied needs for which CSs desire additional assistance or support. A profound comprehension and measurement of CSs' unmet needs play a pivotal role in identifying gaps in their care experiences, providing an opportunity to deliver patient-centered services.
Effective care delivery not only enhances patient outcomes and quality of life but also contributes to increased satisfaction with care. This, in turn, may lead to a reduced demand for health and social care services. The qualitative study outlined here seeks to delve into the unmet needs of individuals who have undergone a cancer diagnosis within the past years and have completed the acute phase of treatment.
The study aims to leverage the experiences of patients, caregivers, and stakeholders to optimize cancer survivorship care. Specifically, the investigation will focus on the unmet needs of cancer survivors post the acute treatment phase for some of the most prevalent forms of cancer with a life expectancy of at least five years.
Namely:
- To investigate the unmet needs perceived by cancer survivors in AUSL IRCCS Reggio Emilia setting.
- To determine the area of impact on health encompassed by those unmet needs to create a direct link to the ICF.
- To determine which Patient Reported Outcome Measure aimed at identifying cancer survivors' unmet needs will best investigate those ICF components connected to common cancer survivors' unmet needs to implement it in their routine assessment.
- To identify the services that need to be implemented to provide support to the true needs of local cancer survivors.
- To develop a Survivorship care plan model coherent with patients' expectations and health care system economic resources.
Utilizing focus groups and interviews, the research will recruit participants from the AUSL - IRCCS Reggio Emilia district who have completed treatment for breast, prostate, colorectal, thyroid, and multiple myeloma cancers. The study will adhere to a structured schedule for conducting focus groups and interviews, accommodating participants in individual interviews if logistical or personal challenges arise.
Each focus group, homogeneous in terms of pathology, will include 4 to 8 participants, with a total ranging between 30 and 60 participants based on Krueger's recommendations. Audio recording and verbatim transcription of focus groups and interviews will facilitate subsequent framework and thematic analysis to extract meaningful insights.
The study's objectives encompass investigating perceived unmet needs, determining the health impact linked to these needs within the International Classification of Functioning, Disability, and Health (ICF), identifying suitable Patient Reported Outcome Measures, pinpointing services for implementation, and developing a Survivorship care plan model aligning with patient expectations and healthcare system resources.
The focus groups and interviews, including patients with or without linked caregivers, will be systematically transcribed and analyzed using framework and thematic analysis methodologies.
- Conditions
- Cancer, Breast Cancer, Prostate Cancer, Thyroid Cancer, Colorectal Cancer, Lymphoma
- Being tested
- Focus Groups or Interviews
- Keywords
- Unmet needs, Quality of Life, Survivorship care, Cancer, Survivors, Care givers, Stakeholder, Breast, Prostate, Thyroid, Colorectal, Myeloma
- Medical subject headings
- Neoplasms, Breast Neoplasms, Prostatic Neoplasms, Thyroid Neoplasms, Colorectal Neoplasms, Lymphoma, Multiple Myeloma, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus Groups or InterviewsOther
Focus groups and qualitative interview will be conducted with patients, caregivers and stake-holders trying to identify unmet needs of cancer survivors after the acute treatment phase. Individual interviews (in presence or online) will be hold as alternative if it will not be possible (due to logistical or personal problems) to participate in a focus group or if the number of people who would have agreed to participate in that focus group is less than 3
| Study group | Role | What they receive |
|---|---|---|
| Cancer Survivors | Cancer Survivors Receives: Other: Focus Groups or Interviews | |
| Cancer Survivors Caregiver | Family members or/and caregivers Receives: Other: Focus Groups or Interviews | |
| Cancer Survivors Stakeholders | Health professionals, patients associations Receives: Other: Focus Groups or Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experience of Self-reported perception of Unmet Needs
Evaluation from the patients' point of view on their perception of unmet needs, which are those needs that lack the level of service an individual perceives as necessary to achieve optimal well-being. Semi-structured qualitative interviews will be conducted with patients' participating in the study to collect information and description of unsatisfied needs for which cancer survivors would like to receive more assistance or support. These may include (as an example): Stress or other psychological demands, Informational needs, Physical needs, Spiritual needs, among others.
Measured: 1- In the last three months 2- In the last 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start20 Apr 2023
- Primary completionFeb 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for CancerStudies 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda USL Reggio Emilia - IRCCS
- Responsible party
- Principal investigator, Stefania Costi, University of Modena and Reggio Emilia
- Investigators
- Stefania Costi, PhD, Principal investigator, Physical Medicine and Rehabilitation Unit, Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236373
- Sponsor's protocol ID
- UN2023
- Acronym
- Survivorship
- Status last verified
- Dec 2024
- First submitted
- 10 Jan 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Recording will be anonymised and transcripted verbatim. This anonimised material could be shared with other researchers on request
Publications
Contri A, Paltrinieri S, Torreggiani M, Chiara Bassi M, Mazzini E, Guberti M, Campanini I, Ghirotto L, Fugazzaro S, Costi S. Patient-reported outcome measure to implement routine assessment of cancer survivors' unmet needs: An overview of reviews and COSMIN analysis. Cancer Treat Rev. 2023 Nov;120:102622. doi: 10.1016/j.ctrv.2023.102622. Epub 2023 Sep 9.
PubMed 37713972Tralongo P, McCabe MS, Surbone A. Challenge For Cancer Survivorship: Improving Care Through Categorization by Risk. J Clin Oncol. 2017 Oct 20;35(30):3516-3517. doi: 10.1200/JCO.2017.74.3450. Epub 2017 Aug 23. No abstract available.
PubMed 28834437Santos ATCD, Silva RPD, Almeida LM, Bosi MLM, Menezes MFB, Skaba MMVF, Nigenda G, Arruda CAM, Pinheiro CPO, Gonzalez-Robledo MC, Knaul FM. Cancer survivorship needs in Brazil: Patient and family perspective. PLoS One. 2020 Oct 8;15(10):e0239811. doi: 10.1371/journal.pone.0239811. eCollection 2020.
PubMed 33031426Nekhlyudov L, Mollica MA, Jacobsen PB, Mayer DK, Shulman LN, Geiger AM. Developing a Quality of Cancer Survivorship Care Framework: Implications for Clinical Care, Research, and Policy. J Natl Cancer Inst. 2019 Nov 1;111(11):1120-1130. doi: 10.1093/jnci/djz089.
PubMed 31095326McCanney J, Winckworth-Prejsnar K, Schatz AA, Nardi EA, Dwyer AJ, Lieu C, Biru Y, Carlson RW. Addressing Survivorship in Cancer Care. J Natl Compr Canc Netw. 2018 Jul;16(7):801-806. doi: 10.6004/jnccn.2018.7054.
PubMed 30006422Contri A, Ghirotto L, Cavuto S, Schiavi M, Cervi E, Soffientini V, Soncini S, Botti S, Frasoldati A, Torreggiani M, Costi S. From patient voices to optimal PROMs: a mixed methods framework for cancer survivorship care. J Cancer Surviv. 2025 Nov 7. doi: 10.1007/s11764-025-01899-x. Online ahead of print.
PubMed 41201742Contri A, Costi S, Guberti M, Soncini S, Botti S, Frasoldati A, Torreggiani M, Ghirotto L. Voices of Survivorship: The Unmet Needs of Italian Cancer Survivors. A Qualitative Study. Cancer Med. 2025 Aug;14(15):e71121. doi: 10.1002/cam4.71121.
PubMed 40747540
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Unmet Needs of Cancer Survivors in Ausl IRCCS Reggio Emilia Reality: a Qualitative Study and Framework Analysis
- ClinicalTrials.gov ID
- NCT06236373
- Acronym / sponsor ID
- Survivorship / UN2023
- Conditions
- Cancer, Breast Cancer, Prostate Cancer, Thyroid Cancer, Colorectal Cancer, Lymphoma
- Keywords
- Unmet needs, Quality of Life, Survivorship care, Cancer, Survivors, Care givers, Stakeholder, Breast
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of Modena and Reggio EmiliaUniversity, hospital or other
- Collaborators
- Azienda USL Reggio Emilia - IRCCS
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This qualitative study seeks to explore the unmet needs of individuals who have recently undergone a cancer diagnosis and completed the acute phase of treatment. The primary objective is to utilize the experiences of patients, caregivers, and stakeholders to enhance the aftercare provided to cancer survivors. By delving into patient perceptions regarding unmet needs in cancer aftercare, the study aims to identify areas for redesigning and improving services to minimize these needs and ultimately enhance patient outcomes. Importantly, the investigation incorporates insights from patients, their caregivers, and stakeholders.
The research will employ qualitative methods, specifically focus groups and interviews, to gather comprehensive perspectives from individuals in the Ausl IRCCS Reggio Emilia district who have completed treatment for breast, prostate, colorectal, thyroid, and multiple myeloma cancers. Including patients with diverse cancer types is crucial for capturing a broad spectrum of experiences.
During data collection, both focus group discussions and interviews will be recorded in audio format and transcribed verbatim. This meticulous approach ensures an accurate representation of participants' voices and experiences. The subsequent analysis will employ a combination of framework and thematic analysis to extract meaningful insights and synthesize the data effectively.
The study's ultimate goal is to leverage the findings to optimize aftercare services for cancer survivors within the local context of Ausl IRCCS Reggio Emilia. By incorporating the perspectives of patients, caregivers, and stakeholders, the research aims to contribute valuable insights that can inform the redesign and improvement of aftercare services, ultimately benefitting cancer survivors in the region.
Detailed description
The escalating global population of cancer survivors (CSs) underscores the imperative to offer services tailored to address their specific unmet needs. Individuals are designated as 'cancer survivors' from the moment of diagnosis onward throughout their lifetime. Despite this, there is a worldwide acknowledgment that CSs encounter a spectrum of physical, psychosocial, spiritual, informational, and practical challenges, often leading to unmet needs that frequently go unrecognized and unaddressed.
Unmet needs, in this context, refer to those requirements perceived by individuals as lacking the necessary level of service for achieving optimal well-being. These can be characterized as unsatisfied needs for which CSs desire additional assistance or support. A profound comprehension and measurement of CSs' unmet needs play a pivotal role in identifying gaps in their care experiences, providing an opportunity to deliver patient-centered services.
Effective care delivery not only enhances patient outcomes and quality of life but also contributes to increased satisfaction with care. This, in turn, may lead to a reduced demand for health and social care services. The qualitative study outlined here seeks to delve into the unmet needs of individuals who have undergone a cancer diagnosis within the past years and have completed the acute phase of treatment.
The study aims to leverage the experiences of patients, caregivers, and stakeholders to optimize cancer survivorship care. Specifically, the investigation will focus on the unmet needs of cancer survivors post the acute treatment phase for some of the most prevalent forms of cancer with a life expectancy of at least five years.
Namely:
- To investigate the unmet needs perceived by cancer survivors in AUSL IRCCS Reggio Emilia setting.
- To determine the area of impact on health encompassed by those unmet needs to create a direct link to the ICF.
- To determine which Patient Reported Outcome Measure aimed at identifying cancer survivors' unmet needs will best investigate those ICF components connected to common cancer survivors' unmet needs to implement it in their routine assessment.
- To identify the services that need to be implemented to provide support to the true needs of local cancer survivors.
- To develop a Survivorship care plan model coherent with patients' expectations and health care system economic resources.
Utilizing focus groups and interviews, the research will recruit participants from the AUSL - IRCCS Reggio Emilia district who have completed treatment for breast, prostate, colorectal, thyroid, and multiple myeloma cancers. The study will adhere to a structured schedule for conducting focus groups and interviews, accommodating participants in individual interviews if logistical or personal challenges arise.
Each focus group, homogeneous in terms of pathology, will include 4 to 8 participants, with a total ranging between 30 and 60 participants based on Krueger's recommendations. Audio recording and verbatim transcription of focus groups and interviews will facilitate subsequent framework and thematic analysis to extract meaningful insights.
The study's objectives encompass investigating perceived unmet needs, determining the health impact linked to these needs within the International Classification of Functioning, Disability, and Health (ICF), identifying suitable Patient Reported Outcome Measures, pinpointing services for implementation, and developing a Survivorship care plan model aligning with patient expectations and healthcare system resources.
The focus groups and interviews, including patients with or without linked caregivers, will be systematically transcribed and analyzed using framework and thematic analysis methodologies.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cancer Survivors | – | Other: Focus Groups or InterviewsCancer Survivors |
| Cancer Survivors Caregiver | – | Other: Focus Groups or InterviewsFamily members or/and caregivers |
| Cancer Survivors Stakeholders | – | Other: Focus Groups or InterviewsHealth professionals, patients associations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer survivors who have recived a diagnosis of the following types of cancer: * breast, * prostate, * thyroid, * colorectal, * multiple myeloma * lymphoma Or caregiver/stakeholder of an individual who meets the inclusion criteria and are aged 18 years or over
Key inclusion criteria (4 listed)
- Adult aged18 years or over.
- Individuals who have a history of breast, prostate, thyroid, colorectal, multiple myeloma or lymphoma cancer within the past years who have completed the acute phase of treatment, and are in follow-up or are receiving maintenance treatment;
- Caregivers for an individual who meets the above criteria, who are aged 18 years or over.
- Stakeholders for individual who meets the above criteria, who are aged 18 years or over.
Key exclusion criteria (3 listed)
- Individuals who do not wish to participate
- Individuals who do not understand and/or speak Italian
- Individuals with significant cognitive impairment, learning difficulty, or communication difficulty such that understanding the nature of the study, the interview questions, or participating in a focus group or an on-line or in-presence interview would not be practical.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus Groups or InterviewsFocus groups and qualitative interview will be conducted with patients, caregivers and stake-holders trying to identify unmet needs of cancer survivors after the acute treatment phase. Individual interviews (in presence or online) will be hold as alternative if it will not be possible (due to logistical or personal problems) to participate in a focus group or if the number of people who would have agreed to participate in that focus group is less than 3 | Other | Cancer Survivors, Cancer Survivors Caregiver, Cancer Survivors Stakeholders |
Primary outcome
Experience of Self-reported perception of Unmet Needs
Time frame: 1- In the last three months 2- In the last 12 months
Evaluation from the patients' point of view on their perception of unmet needs, which are those needs that lack the level of service an individual perceives as necessary to achieve optimal well-being. Semi-structured qualitative interviews will be conducted with patients' participating in the study to collect information and description of unsatisfied needs for which cancer survivors would like to receive more assistance or support. These may include (as an example): Stress or other psychological demands, Informational needs, Physical needs, Spiritual needs, among others.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Background: PubMed 37713972Contri A, Paltrinieri S, Torreggiani M, Chiara Bassi M, Mazzini E, Guberti M, Campanini I, Ghirotto L, Fugazzaro S, Costi S. Patient-reported outcome measure to implement routine assessment of cancer survivors' unmet needs: An overview of reviews and COSMIN analysis. Cancer Treat Rev. 2023 Nov;120:102622. doi: 10.1016/j.ctrv.2023.102622. Epub 2023 Sep 9.
- Background: PubMed 28834437Tralongo P, McCabe MS, Surbone A. Challenge For Cancer Survivorship: Improving Care Through Categorization by Risk. J Clin Oncol. 2017 Oct 20;35(30):3516-3517. doi: 10.1200/JCO.2017.74.3450. Epub 2017 Aug 23. No abstract available.
- Background: PubMed 33031426Santos ATCD, Silva RPD, Almeida LM, Bosi MLM, Menezes MFB, Skaba MMVF, Nigenda G, Arruda CAM, Pinheiro CPO, Gonzalez-Robledo MC, Knaul FM. Cancer survivorship needs in Brazil: Patient and family perspective. PLoS One. 2020 Oct 8;15(10):e0239811. doi: 10.1371/journal.pone.0239811. eCollection 2020.
- Background: PubMed 31095326Nekhlyudov L, Mollica MA, Jacobsen PB, Mayer DK, Shulman LN, Geiger AM. Developing a Quality of Cancer Survivorship Care Framework: Implications for Clinical Care, Research, and Policy. J Natl Cancer Inst. 2019 Nov 1;111(11):1120-1130. doi: 10.1093/jnci/djz089.
- Background: PubMed 30006422McCanney J, Winckworth-Prejsnar K, Schatz AA, Nardi EA, Dwyer AJ, Lieu C, Biru Y, Carlson RW. Addressing Survivorship in Cancer Care. J Natl Compr Canc Netw. 2018 Jul;16(7):801-806. doi: 10.6004/jnccn.2018.7054.
- Derived from this study: PubMed 41201742Contri A, Ghirotto L, Cavuto S, Schiavi M, Cervi E, Soffientini V, Soncini S, Botti S, Frasoldati A, Torreggiani M, Costi S. From patient voices to optimal PROMs: a mixed methods framework for cancer survivorship care. J Cancer Surviv. 2025 Nov 7. doi: 10.1007/s11764-025-01899-x. Online ahead of print.
- Derived from this study: PubMed 40747540Contri A, Costi S, Guberti M, Soncini S, Botti S, Frasoldati A, Torreggiani M, Ghirotto L. Voices of Survivorship: The Unmet Needs of Italian Cancer Survivors. A Qualitative Study. Cancer Med. 2025 Aug;14(15):e71121. doi: 10.1002/cam4.71121.
- Individual participant dataSharing planned: Undecided. Recording will be anonymised and transcripted verbatim. This anonimised material could be shared with other researchers on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefania Costi, PhD principal investigator
Physical Medicine and Rehabilitation Unit, Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Breast Cancer, run by University of Modena and Reggio Emilia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angela Contri, MA (+393478824741, angela.contri@unimore.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experience of Self-reported perception of Unmet Needs (time frame: 1- In the last three months 2- In the last 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06236373, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.