the Challenges of Young Adults With Cancer

Not yet recruiting

• Conditions: AYA Cancer Patients; AYA Cancer Survivors

• Registration Number: NCT06594510
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-04
• Study First Submitted QC: 2024-09-10
• Last Update Submitted: 2024-09-10
• Study First Posted: 2024-09-13
• Last Update Posted: 2024-09-13
• Study Start: 2025-06-01
• Primary Completion: 2025-12-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 580

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AYA Quality of life (QoL)	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
AYA Education	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.
AYA Finances and Insurance	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.
AYA Childbearing and Parenting	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.

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Chirurgia Generale 1; 🇮🇹 Roma, Italy