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Not yet recruiting NCT06594510

the Challenges of Young Adults With Cancer

Observational AYA Cancer Patients AYA Cancer Survivors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: AYA Cancer Patients, AYA Cancer Survivors. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

AYANDRA Study: Addressing Youth and Adolescent Needs in Development, Research, and Advocacy

Overview

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

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.

Primary outcome measures

  • AYA Quality of life (QoL) [Time frame: From answering to the end of the survey after 15 minutes]
  • AYA Education [Time frame: From answering to the end of the survey after 15 minutes]
  • AYA Finances and Insurance [Time frame: From answering to the end of the survey after 15 minutes]
  • AYA Childbearing and Parenting [Time frame: From answering to the end of the survey after 15 minutes]

Eligibility criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Italy · 1 center
  • Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Chirurgia Generale 1 — Roma

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. PMID 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. PMID 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 PMID 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. PMID 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. PMID 28173936

Identifiers

NCT: NCT06594510 · ID 7061

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗