The Unmet Needs of Cancer Survivors in Ausl IRCCS Reggio Emilia
NCT ID: NCT06236373
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
45 participants
OBSERVATIONAL
2023-04-20
2025-10-31
Brief Summary
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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
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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:
1. To investigate the unmet needs perceived by cancer survivors in AUSL IRCCS Reggio Emilia setting.
2. To determine the area of impact on health encompassed by those unmet needs to create a direct link to the ICF.
3. 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.
4. To identify the services that need to be implemented to provide support to the true needs of local cancer survivors.
5. 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
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Cancer Survivors
Cancer Survivors
Focus Groups or Interviews
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
Cancer Survivors Caregiver
Family members or/and caregivers
Focus Groups or Interviews
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
Cancer Survivors Stakeholders
Health professionals, patients associations
Focus Groups or Interviews
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
Interventions
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Focus Groups or Interviews
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
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Azienda USL - IRCCS di Reggio Emilia
UNKNOWN
University of Modena and Reggio Emilia
OTHER
Responsible Party
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Stefania Costi
PhD
Principal Investigators
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Stefania Costi, PhD
Role: PRINCIPAL_INVESTIGATOR
Physical Medicine and Rehabilitation Unit, Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia
Locations
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Casa della Salute ex Spallanzani
Reggio Emilia, Reggio Emilia, Italy
Countries
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Central Contacts
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Facility Contacts
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Angela Contri, MA
Role: primary
Role: backup
Angela Contri, MA
Role: backup
Stefania Costi, PhD
Role: backup
Luca Ghirotto, PhD
Role: backup
Martina Torreggiani, MSc
Role: backup
Monica Guberti, PhD
Role: backup
References
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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.
Tralongo 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.
Santos 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.
Nekhlyudov 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.
McCanney 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.
Contri 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.
Other Identifiers
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UN2023
Identifier Type: -
Identifier Source: org_study_id