Clinical trial NCT06594510: the Challenges of Young Adults With Cancer
Official title: AYANDRA Study: Addressing Youth and Adolescent Needs in Development, Research, and Advocacy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: AYA Cancer Patients
AYA Cancer Survivors
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 580
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adolescent and Young Adults with gastrointestinal and breast cancers aged 13-39 -years old at diagnosis.

Brief summary: The study aims to describe unmet needs of Adolescent \&amp;amp; 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.

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.

Primary outcomes:
measure: AYA Quality of life (QoL)
timeFrame: From answering to the end of the survey after 15 minutes
measure: AYA Education
timeFrame: From answering to the end of the survey after 15 minutes
measure: AYA Finances and Insurance
timeFrame: From answering to the end of the survey after 15 minutes
measure: AYA Childbearing and Parenting
timeFrame: From answering to the end of the survey after 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Chirurgia Generale 1
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Laura Lorenzon
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.