Gynecologic Cancer
Conditions
Brief summary
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.
Detailed description
Clinical, diagnosis and treatment characteristics will be determined. In addition, oncological (e.g., disease-free and overall survival), late-term physical (e.g., cardiovascular, second primary tumor), sexual and reproductive health (e.g., body image, sexual functioning, fertility preservation, pregnancy rate, premature ovarian insufficiency), psychological (e.g., anxiety and depression) and social (e.g. (un)employment, financial toxicity) outcomes will be determined.
Interventions
OTHERQuestionnaire 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.
OTHERQuestionnaire 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.
OTHERQuestionnaire 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).
OTHERQuestionnaire 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.
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
Gynecological cancer types include but are not limited to the following: * Ovarian cancer - borderline tumors with invasive peritoneal implants, epithelial carcinoma (endometrioid, clear cell, high-grade serous, low-grade serous, mucinous, undifferentiated), germ cell tumor (dysgerminoma, immature teratomas, yolk sac tumors, embryonal carcinomas, carcinoid tumors), sex cord stromal tumor (gynandroblastoma, granulosa cell tumor, Sertoli-Leydig cell tumor, steroid cell tumor) * Cervical cancer - squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma, carcinoma in situ with stromal microinvasion (to be considered as microinvasive carcinoma), other * Endometrial cancer - endometrioid, papillary serous, clear cell, carcinosarcoma * Sarcoma - uterine sarcoma (incl. leiomyosarcoma, endometrial stromal sarcoma, adenosarcoma) * Gestational trophoblastic neoplasms - invasive mole, choriosarcoma, placental site trophoblastic tumor, epithelioid trophoblastic tumor, other * Vulvar-vaginal cancer - squamous cell carcinoma, M. Paget, other
Exclusion criteria
1. Mentally disabled or patients with significantly altered mental status that would prohibit understanding and giving informed consent 2. Patients who do not provide informed consent on data collection and storage for scientific purposes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcomes | 10 years | The number of Adolescents and Young Adults diagnosed with gynecological cancer who receive treatment at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS hospital during a five-year period and their clinical characteristics, i.e., demographics, diagnosis, imaging, treatment and clinical trial participation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Late-term physical effects - genital disorders | 10 years | Number of patients who developed genital disorders |
| Late-term physical effects - endocrine/metabolic disorders | 10 years | Number of patients who developed endocrine/metabolic disorders |
| Late-term physical effects - musculoskeletal disorders | 10 years | Number of patients who developed musculoskeletal disorders |
| Survival outcomes | 10 years | Oncological outcomes, i.e., progression-free survival, disease-specific and overall survival |
| Late-term physical effects - neurocognitive disorders | 10 years | Number of patients who developed neurocognitive disorders |
| Late-term physical effects - auditory disorders | 10 years | Number of patients who developed auditory disorders |
| Late-term physical effects - ocular disorders | 10 years | Number of patients who developed ocular disorders |
| Late-term physical effects - oral/dental disorders | 10 years | Number of patients who developed oral/dental disorders |
| Late-term physical effects - dermatological disorders | 10 years | Number of patients who developed dermatological disorders |
| Late-term physical effects - cardiovascular disorders | 10 years | Number of patients who developed cardiovascular disorders |
| Late-term physical effects - pulmonary disorders | 10 years | Number of patients who developed pulmonary disorders |
| Late-term physical effects - gastro-intestinal disorders | 10 years | Number of patients who developed gastro-intestinal disorders |
| Late-term physical effects - urinary tract disorders | 10 years | Number of patients who developed urinary tract disorders |
| Late-term physical effects - neurological disorders | 10 years | Number of patients who developed neurological disorders |
| Late-term physical effects - immune disorders | 10 years | Number of patients who developed immune disorders |
| Late-term physical effects - subsequent malignant neoplasms | 10 years | Number of patients who developed subsequent malignant neoplasms |
| Sexual outcomes - Body Appreciation Scale-2 | 10 years | The 10-item BAS-2 uses a 5-point Likert scale with responses ranging from 1 (never) to 5 (always) and has demonstrated positive ties between body appreciation and one's psychological well-being (e.g., self-esteem, optimism, positive affect, and negative links with body surveillance, body shame, and body dissatisfaction) |
| Sexual outcomes - Sexual Adjustment and Body Image Scale in Gynecological cancer (SABIS-G) | 10 years | The Sexuality and Body Image Scale for women with Gynecological cancer (SABIS-G) consists of a 7-item measure with 3 items related to body image and 4 related to sexual adjustment. To score the SABIS-G each variable is scored from 1 to 5, with 5 as the best outcome. The body image subscale sum ranges from 3 to 15 and the sexual adjustment subscale sum ranges from 4 to 20. |
| Sexual outcomes - Female Sexual Function Index (FSFI) | 10 years | The Female Sexual Function Index (FSFI) is a survey measuring the sexual functioning of women in six different domains: desire, arousal, lubrication, orgasm, satisfaction and pain over the past 30 days. Each domain is scored from 0 to 5 with 5 as the best outcome. |
| Sexual outcomes - EORTC Sexual Health (SH-22) questionnaire | 10 years | The 22-item EORTC sexual health questionnaire developed to assess sexual health in male and female cancer patients and cancer survivors and ranges from 1 to 4 with 4 as the best outcome. |
| Reproductive outcomes - fertility preservation | 10 years | Number of patients who underwent fertility preservation, number of pregnancies achieved, number of live births achieved |
| Reproductive outcomes - Decision Regret Scale (DRS) | 10 years | The Decision Regret Scale (DRS) measures distress or 'remorse' after a health care decision and ranges from 1 to 5 with 5 as the worst outcome |
| Reproductive outcomes - Reproductive Concerns After Cancer (RCAC) scale | 10 years | The Reproductive Concerns After Cancer (RCAC) scale is a multidimensional measure of possible reproductive concerns of women following cancer diagnosis and treatment, yielding six subscale scores: fertility potential, partner disclosure of fertility status, child's health, personal health, acceptance of possible infertility, and becoming pregnant. The scale ranges from 1 to 5 with 5 as the worst outcome. |
| Reproductive outcomes - Iatrogenic menopause | 10 years | Type of treatments received related to iatrogenic menopause |
| Reproductive outcomes - Menopause Quality of Life (MenQoL) questionnaire | 10 years | The extent of menopause-related disturbances patients experienced, ranging from 0 to 6 with 6 as the worst outcome. |
| Psychological outcomes - EORTC-C30 general quality of life questionnaire | 10 years | This is a 30-item HRQoL questionnaire consisting of five functional scales (physical, role, cognitive, emotional, and social), a global quality-of-life scale, three symptom scales (fatigue, pain, nausea and vomiting) and a number of single items assessing common symptoms (dyspnea, loss of appetite, sleep disturbance, constipation, and diarrhea) and the perceived financial impact of the disease. It has 28 items ranging from 1 to 4 with 4 as the worst outcome and two items ranging from 0 to 7 with 7 as the best outcome. |
| Social outcomes - Productivity Cost Questionnaire (iPCQ) | 10 years | Productivity Cost Questionnaire (iPCQ) will be used to evaluate the impact of disease on the productivity of a person |
| Psychological outcomes - Clinical outcomes in Routine Evaluation (CORE-OM) | 10 years | Clinical outcomes in Routine Evaluation (CORE-OM) is a 34-item evaluation covering four domains: wellbeing, problems, functioning and risk. The score ranges from 0 to 4 with 4 as the worst outcome. |
| Psychological outcomes - Ten Item Personality Inventory (TIPI) | 10 years | Ten Item Personality Inventory (TIPI) is a 10-item measure of the Big-Five dimensions (extraversion, agreeableness, conscientiousness, emotional stability, openness). |
| Psychological outcomes - Hospital Anxiety and Depression Scale (HADS) | 10 years | The Hospital Anxiety and Depression Scale (HADS) is a 14-item scale with 7 items each for assessing symptoms of anxiety and depression, each item ranging from 0 to 3. Summing up this items a final assesment is obtained: 0-7 = Normal, 8-10 = Borderline abnormal (borderline case),11-21 = Abnormal (case). |
| Psychological outcomes - Distress thermometer | 10 years | The distress thermometer is one-item measure that assesses the level of distress patients have experienced in the preceding week and uses a 0-10 rating scale. |
| Psychological outcomes - General Self-Efficacy (GSE) Scale | 10 years | The General Self-Efficacy (GSE) Scale consists of ten items to examine the patient's problem-solving abilities. The scale ranges from 1 to 4 with 4 as the best outcome. |
| Psychological outcomes - Mini-Mental Adjustment to Cancer (Mini-MAC) | 10 years | The Mini-Mental Adjustment to Cancer (Mini-MAC) scale examines the patients' attitudes towards cancer using a 4-point Likert scale. |
| Psychological outcomes - Cancer Worry Scale (CWS) | 10 years | The 8-item Cancer Worry Scale (CWS) assesses concerns regarding cancer diagnosis using a 4-point Likert scale with 4 as the worst outcome. |
| Psychological outcomes - Multidimensional Scale of Perceived Social Support (MSPSS) | 10 years | The 12-item Multidimensional Scale of Perceived Social Support (MSPSS) examines to what extent the patient has received support from family members, relatives and friends, ranging from 1 to 7 with 7 as the best outcome. |
| Social outcomes - Medical Consumption Questionnaire (iMCQ) | 10 years | Number of occurring contacts with health care providers and time off from work for doctors' visits. |
| Social outcomes - Comprehensive Score for Financial Toxicity - Functional Assessment of Chronic Illness Therapy (COST-FACIT) tool | 10 years | The Comprehensive Score for Financial Toxicity - Functional Assessment of Chronic Illness Therapy (COST-FACIT) tool represents a patient-reported outcome measure that describes the financial distress experienced by cancer patients using a 5-point Likert scale ranging from 0 to 4 with 4 as the worst outcome. |
| Psychological outcomes - Patient Health Engagement scale | 10 years | The 5-item Patient Health Engagement scale examines to what extent the patient is able to manage her disease ranging from 0-7 with 7 as the best outcome. |
| Psychological outcomes - Supportive Care Needs Survey-Short Form (SCNS-SF34) | 10 years | The Supportive Care Needs Survey-Short Form (SCNS-SF34) is a 34-item, validated measure of cancer-specific perceived needs across five domains: psychological, health systems and information, physical and daily living, patient care and support, and sexuality. Patients rate their level of need for help in the past month, scale ranges from 1 (no need/not applicable) to 5 (high need). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Comparison of clinical characteristics with patients beyond this age-specific cohort | 10 years | Comparison of the clinical characteristics (demographics, diagnosis, imaging, treatment and clinical trial participation) of Gemelli Adolescents and Young Adults diagnosed with gynecological cancer to patients beyond this age-specific cohort who have been treated during the same study period |
| Comparison of oncological outcomes with patients beyond this age-specific cohort | 10 years | Comparison of progression-free survival, disease-specific and overall survival between Adolescents and Young Adults (15-39 years old at time of diagnosis) versus patients either younger than 15 and/or older than 39 years old. |
Countries
Italy
Contacts
Primary ContactGiovanni Scambia
Outcome results
None listed