The Unmet Needs of Cancer Survivors in Ausl IRCCS Reggio Emilia (Survivorship)

January 23, 2024 updated by: Stefania Costi, University of Modena and Reggio Emilia

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Reggio Emilia, Italy, 42123
        • Recruiting
        • Casa della Salute ex Spallanzani
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Angela Contri, MA
        • Principal Investigator:
          • Stefania Costi, PhD
        • Sub-Investigator:
          • Luca Ghirotto, PhD
        • Sub-Investigator:
          • Martina Torreggiani, MSc
        • Sub-Investigator:
          • Monica Guberti, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cancer Survivors
Other: 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
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1- In the last three months 2- In the last 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Modena and Reggio Emilia

Collaborators

Azienda USL - IRCCS di Reggio Emilia

Investigators

  • Principal Investigator: Stefania Costi, PhD, Physical Medicine and Rehabilitation Unit, Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2023

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

January 10, 2024

First Submitted That Met QC Criteria

January 23, 2024

First Posted (Actual)

February 1, 2024

Study Record Updates

Last Update Posted (Actual)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 23, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UN2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Recording will be anonymised and transcripted verbatim. This anonimised material could be shared with other researchers on request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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