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

Not yet recruitingOBSERVATIONAL
Enrollment

500

Participants

Timeline

Start Date

September 9, 2024

Primary Completion Date

September 30, 2039

Study Completion Date

March 31, 2040

Conditions
Gynecologic Cancer
Interventions
OTHER

Questionnaire on late-term physical effects

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.

OTHER

Questionnaire on sexual and reproductive health outcomes

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.

OTHER

Questionnaire on psychological outcomes

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).

OTHER

Questionnaire on social outcomes

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.

Trial Locations (1)

00168

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC GINECOLOGIA ONCOLOGICA, Roma

All Listed Sponsors
lead

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

NCT06594471 - Comprehensive Assessment of Clinical Characteristics and Outcomes of Gemelli Adolescents and Young Adults | Biotech Hunter | Biotech Hunter