Comprehensive Assessment of Clinical Characteristics and Outcomes of Gemelli Adolescents and Young Adults

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ID
NCT06594471
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Gynecologic Cancer

Eligibility Criteria

Sex
FEMALE
Age
15 Years - 49 Years
Healthy Volunteers
Not accepted

Interventions

  • Questionnaire on late-term physical effects — OTHER
    Patients will be asked to indicate any potential late-term physical effects following cancer treatment: neurocognitive, auditory, ocular, oral/dental, dermatologic, cardiovascular, pulmonary, gastro-intestinal, urinary tract, genital, endocrine/metabolic, musculoskeletal, neurological, immune disorders and occurrence of any subsequent malignant neoplasms.
  • Questionnaire on sexual and reproductive health outcomes — OTHER
    Patients will be asked to complete the following questionnaires: Body Appreciation Scale-2 (BAS-2), Body Image Scale (BIS), EORTC QLQ-SH22, Body Image Scale in Gynecological Cancer (SABIS-G). Patients who underwent a fertility-sparing procedure will be asked to fill out the Reproductive Concerns after Cancer (RCAC) and Decision Regret Scale (DRS), whereas those who experienced iatrogenic menopause will complete the MENQOL questionnaire to assess menopause-related quality of life.
  • Questionnaire on psychological outcomes — OTHER
    Patients will be asked to complete the following questionaires: EORTC QLQ-C30, Clinical outcomes in Routine Evaluation (CORE-OM), Ten Item Personality Inventory (TIPI), Hospital Anxiety and Depression Scale (HADS), General Self-Efficacy (GSE) Scale, Mini-Mental Adjustment to Cancer (Mini-MAC), Cancer Worry Scale (CWS), Multidimensional Scale of Perceived Social Support (MSPSS), the Patient Health Engagement scale and the Supportive Care Needs Survey-Short Form (SCNS-SF34).
  • Questionnaire on social outcomes — OTHER
    Patients will be asked to complete the following questionaires: Medical Consumption Questionnaire (iMCQ), Productivity Cost Questionnaire (iPCQ) and the Comprehensive Score for Financial Toxicity - Functional Assessment of Chronic Illness Therapy (COST-FACIT) questionnaire.

Study Details

The Adolescent and Young Adults cancer population encompass patients diagnosed with oncological disease at the age of 15-39 years. Although 86% of these patients become long-term cancer survivors, studies have shown that these survival rates lag behind to those of younger and older patients. The underlying reason for this discrepancy is, however, yet poorly understood. Furthermore, these patients may be more often confronted with late effects due to their disease and/or anticancer treatment. Knowledge on Adolescent and Young Adults diagnosed with gynecological cancer at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS hospital in Rome, Italy, is currently lacking and is needed to deliver these patients the best possible care, tailored to their disease characteristics and specific needs. The primary objective of this monocenter observational study is to determine the number of Gemelli Adolescent and Young Adults diagnosed with gynecological cancer and their clinical characteristics. Secondary objectives will be to determine their oncological, late-term physical effects, sexual and reproductive health, psychological and social outcomes. Tertiary outcomes will be to compare the clinical characteristics and oncological outcomes of Gemelli Adolescents and Young Adults to patients beyond this age-specific cohort who have been treated during the same study period.

Key Dates

First listed
Sep 19, 2024
Start date
Sep 9, 2024
Status verified
Sep 2024
Primary completion
Sep 30, 2039
Completion
Mar 31, 2040

Study Design

Enrollment
500 participants (estimated)

Primary Outcome Measure

Clinical outcomes [ Time Frame: 10 years ]

Central Contacts

Related Studies