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NCT Number: NCT06594510

the Challenges of Young Adults With Cancer

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Roma, 00168, Italy

Location contact

Cristina Vacca

CONTACT

[email protected]

Laura Lorenzon

CONTACT

[email protected]

+39067190

Laura Lorenzon

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. AYA Quality of life (QoL)

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

    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

  2. AYA Education

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

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

  3. AYA Finances and Insurance

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

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

  4. AYA Childbearing and Parenting

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Lorenzon, MD

CONTACT

[email protected]

+390630157190

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: AYANDRA

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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