CClinicalTrials.gg
Sign In
Not yet recruitingNCT06594510AYANDRAUpdated Sep 19, 2024

the Challenges of Young Adults With Cancer

An observational study in AYA Cancer Patients and AYA Cancer Survivors, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
580
Ages
18 Years and older
Sex
All
01

Study 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

Read the detailed description

An electronic online questionnaire was developed addressing four main areas: a) quality of life, b) education, c) finances and Insurance, and d) childbearing and parenting. In brief, the first part of the questionnaire will aim to examine the demographic characteristics of the participants, such as their nationality, gender, age at diagnosis, actual age, and level of education, followed by their diagnosis or condition. No clinical data will be collected other than these features. Then, each domain will include 10 questions (multiple choice questions, ranking questions and 7-point Likert scale questions) and investigate the unmet needs in AYA with gastrointestinal and breast cancers.

02

Conditions studied

  • AYA Cancer Patients
  • AYA Cancer Survivors
03

In context

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Age: 18 years old at survey participation;
  • Patients 13 - 39 years old at diagnosis;
  • Hematologic malignancies or different cancers.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
580 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: From answering to the end of the survey after 15 minutes

  2. AYA Education

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

    Time frame: From answering to the end of the survey after 15 minutes

  3. 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.

    Time frame: From answering to the end of the survey after 15 minutes

  4. 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.

    Time frame: From answering to the end of the survey after 15 minutes

07

Study locations

1 site
08

References and documents

Publications

  • 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. PubMed 33619021 ↗
  • 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. PubMed 32129904 ↗
  • 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. PubMed 33926710 ↗
  • 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. PubMed 32940362 ↗
  • 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. PubMed 28173936 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06594510
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Jun 1, 2025 (estimated)
Primary completion
Dec 1, 2025 (estimated)
Completion
Jun 1, 2026 (estimated)
Last update
Sep 19, 2024

Study contacts

Laura Lorenzon, MD
Contact
laura.lorenzon@policlinicogemelli.it
+390630157190
Laura Lorenzon
principal investigator · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Start the discussion