NCT06594510

Brief Summary

The study aims to describe unmet needs of Adolescent \& Young Adults (AYA) with gastrointestinal and breast cancers in relation to: a) quality of life, b) education, c) finances and Insurance, and d) childbearing and parenting in Europe

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
580

participants targeted

Target at P75+ for all trials

Timeline
0mo left

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress98%
Jun 2025Jun 2026

First Submitted

Initial submission to the registry

September 4, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

6 months

First QC Date

September 4, 2024

Last Update Submit

September 10, 2024

Conditions

AYA Cancer PatientsAYA Cancer Survivors

Outcome Measures

Primary Outcomes (4)

  • AYA Quality of life (QoL)

    Assessed by the EQ-5D-5L index and the descriptive statistic of the unmet needs in relation to the 4 domains of investigation, : a) quality of life, b) education, c) finances and Insurance, and d) childbearing and parenting

    From answering to the end of the survey after 15 minutes

  • AYA Education

    Assessed by the descriptive statistic of the unmet needs obtained from the survey in relation to the 4 domains of investigation.

    From answering to the end of the survey after 15 minutes

  • AYA Finances and Insurance

    Assessed by the descriptive statistic of the unmet needs obtained from the survey in relation to the 4 domains of investigation.

    From answering to the end of the survey after 15 minutes

  • AYA Childbearing and Parenting

    Assessed by the descriptive statistic of the unmet needs obtained from the survey in relation to the 4 domains of investigation.

    From answering to the end of the survey after 15 minutes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adolescent and Young Adults with gastrointestinal and breast cancers aged 13-39 -years old at diagnosis.

You may qualify if:

  • Age: 18 years old at survey participation, as long as aged 13-39 years old at diagnois;
  • Gastrointestinal cancer (colorectal, gastric, pancreatic) or breast cancer.

You may not qualify if:

  • Age: 18 years old at survey participation;
  • Patients 13 - 39 years old at diagnosis;
  • Hematologic malignancies or different cancers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Chirurgia Generale 1

Roma, 00168, Italy

Location

Related Publications (5)

  • Nichols HB, Baggett CD, Engel SM, Getahun D, Anderson C, Cannizzaro NT, Green L, Gupta P, Laurent CA, Lin PC, Meernik C, Moy LM, Wantman E, Xu L, Kwan ML, Mersereau JE, Chao CR, Kushi LH. The Adolescent and Young Adult (AYA) Horizon Study: An AYA Cancer Survivorship Cohort. Cancer Epidemiol Biomarkers Prev. 2021 May;30(5):857-866. doi: 10.1158/1055-9965.EPI-20-1315. Epub 2021 Feb 22.

    PMID: 33619021RESULT

  • Stoneham SJ. AYA survivorship: The next challenge. Cancer. 2020 May 15;126(10):2116-2119. doi: 10.1002/cncr.32774. Epub 2020 Mar 4. No abstract available.

    PMID: 32129904RESULT

  • Ferrari A, Stark D, Peccatori FA, Fern L, Laurence V, Gaspar N, Bozovic-Spasojevic I, Smith O, De Munter J, Derwich K, Hjorth L, van der Graaf WTA, Soanes L, Jezdic S, Blondeel A, Bielack S, Douillard JY, Mountzios G, Saloustros E. Adolescents and young adults (AYA) with cancer: a position paper from the AYA Working Group of the European Society for Medical Oncology (ESMO) and the European Society for Paediatric Oncology (SIOPE). ESMO Open. 2021 Apr;6(2):100096. doi: 10.1016/j.esmoop.2021.100096.

    PMID: 33926710RESULT

  • Miller KD, Fidler-Benaoudia M, Keegan TH, Hipp HS, Jemal A, Siegel RL. Cancer statistics for adolescents and young adults, 2020. CA Cancer J Clin. 2020 Nov;70(6):443-459. doi: 10.3322/caac.21637. Epub 2020 Sep 17.

    PMID: 32940362RESULT

  • Pilozzi E, Lorenzon L, Lo Baido S, Ferri M, Duranti E, Fochetti F, Mercantini P, Ramacciato G, Balducci G, Ruco L. Left-sided early onset colorectal carcinomas: A sporadic neoplasm with aggressive behavior. Am J Surg. 2017 Sep;214(3):421-427. doi: 10.1016/j.amjsurg.2017.01.035. Epub 2017 Jan 31.

    PMID: 28173936RESULT

Study Officials

  • Laura Lorenzon

    Fondazione Policlinico Universitario A. Gemelli, IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Lorenzon, MD

CONTACT

+390630157190laura.lorenzon@policlinicogemelli.it

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2024

First Posted

September 19, 2024

Study Start

June 1, 2025

Primary Completion

December 1, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

IT(1)