NCT06236373

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

1.8 years

First QC Date

January 10, 2024

Last Update Submit

December 4, 2024

Conditions

Keywords

Unmet needsQuality of LifeSurvivorship careCancerSurvivorsCare giversStakeholderBreastProstateThyroidColorectalMyeloma

Outcome Measures

Primary Outcomes (1)

  • 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.

    1- In the last three months 2- In the last 12 months

Study Arms (3)

Cancer Survivors

Cancer Survivors

Other: Focus Groups or Interviews

Cancer Survivors Caregiver

Family members or/and caregivers

Other: Focus Groups or Interviews

Cancer Survivors Stakeholders

Health professionals, patients associations

Other: Focus Groups or Interviews

Interventions

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 SurvivorsCancer Survivors CaregiverCancer Survivors Stakeholders

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Casa della Salute ex Spallanzani

Reggio Emilia, Reggio Emilia, 42123, Italy

RECRUITING

Related Publications (7)

  • 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.

    PMID: 37713972BACKGROUND
  • 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.

    PMID: 28834437BACKGROUND
  • 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.

    PMID: 33031426BACKGROUND
  • 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.

    PMID: 31095326BACKGROUND
  • 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.

    PMID: 30006422BACKGROUND
  • Contri 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.

  • 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.

MeSH Terms

Conditions

NeoplasmsBreast NeoplasmsProstatic NeoplasmsThyroid NeoplasmsColorectal NeoplasmsLymphomaMultiple MyelomaThyroid DiseasesNeoplasms, Plasma Cell

Interventions

Focus GroupsInterviews as Topic

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesEndocrine Gland NeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Stefania Costi, PhD

    Physical Medicine and Rehabilitation Unit, Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefania Costi, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 10, 2024

First Posted

February 1, 2024

Study Start

April 20, 2023

Primary Completion

February 1, 2025

Study Completion

October 1, 2025

Last Updated

December 9, 2024

Record last verified: 2024-12

Locations