Trial Title:
The Unmet Needs of Cancer Survivors in Ausl IRCCS Reggio Emilia
NCT ID:
NCT06236373
Condition:
Cancer
Breast Cancer
Prostate Cancer
Thyroid Cancer
Colorectal Cancer
Lymphoma
Multiple Myeloma
Neoplasms
Conditions: Official terms:
Multiple Myeloma
Conditions: Keywords:
Unmet needs
Quality of Life
Survivorship care
Cancer
Survivors
Care givers
Stakeholder
Breast
Prostate
Thyroid
Colorectal
Myeloma
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Other
Intervention name:
Focus Groups or Interviews
Description:
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
Arm group label:
Cancer Survivors
Arm group label:
Cancer Survivors Caregiver
Arm group label:
Cancer Survivors Stakeholders
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. 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:
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.
Criteria for eligibility:
Study pop:
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
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Casa della Salute ex Spallanzani
Address:
City:
Reggio Emilia
Zip:
42123
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Angela Contri, MA
Phone:
+393478824741
Email:
angela.contri@unimore.it
Contact backup:
Phone ext:
Contri
Email:
angela.contri@libero.it
Investigator:
Last name:
Angela Contri, MA
Email:
Sub-Investigator
Investigator:
Last name:
Stefania Costi, PhD
Email:
Principal Investigator
Investigator:
Last name:
Luca Ghirotto, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Martina Torreggiani, MSc
Email:
Sub-Investigator
Investigator:
Last name:
Monica Guberti, PhD
Email:
Sub-Investigator
Start date:
April 20, 2023
Completion date:
October 2024
Lead sponsor:
Agency:
University of Modena and Reggio Emilia
Agency class:
Other
Collaborator:
Agency:
Azienda USL - IRCCS di Reggio Emilia
Agency class:
Other
Source:
University of Modena and Reggio Emilia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06236373
