Physiological and psychosocial aspects of reproductive health after early-onset colorectal cancer

早发性结直肠癌后生殖健康的生理和社会心理方面

• 批准号: 10660751
• 负责人: Andreana Natalie Holowatyj
• 金额: $ 58.67万
• 依托单位: VANDERBILT UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-11 至 2028-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10660751
• 关键词: Accreditation; Address; Adult; Age; Androstenedione; Biological Assay; Biometry; Blood; Blood specimen; Cancer Center; Cancer Survivor; Caring; Certification; Clinical; Clinical Management; Clinical Psychology; Cohort Studies; Collection; Colorectal Cancer; Continuity of Patient Care; Data; Diagnosis; Dimensions; Early Diagnosis; Enrollment; Estradiol; FDA approved; Face; Family; Fasting; Female; Fertility; Goals; Gonadal structure; Growth; Health; Healthcare; Heterogeneity; Hormones; Immunoassay; Incidence; Institutional Review Boards; Interview; Laboratories; Life Style; Light; Measures; Medical Oncology; Modeling; Newly Diagnosed; Operative Surgical Procedures; Oral Contraceptives; Outcome; Patients; Pattern; Physiological; Population; Premenopause; Prospective cohort; Prospective, cohort study; Psychosocial Assessment and Care; Quality of life; Questionnaires; Radiation therapy; Recording of previous events; Reporting; Reproductive Endocrinology; Reproductive Health; Reproductive History; Research Design; SHBG gene; Sample Size; Sampling; Sex Functioning; Sexual Health; Social support; Standardization; Testosterone; Time; Treatment Protocols; Visit; Women' s Health; cancer care; cancer diagnosis; cancer epidemiology; chemotherapy; child bearing; cohort; colon cancer patients; colorectal cancer treatment; dehydroepiandrosterone; design; early onset colorectal cancer; fertility preservation; follow-up; gastrointestinal; gonad function; improved; improved outcome; inhibin B; innovation; instrument; male; men; multidisciplinary; patient population; pill; prospective; psychologic; psychosocial; reproductive; sample collection; satisfaction; sex; sociodemographics; study population; treatment planning

SUMMARY Despite the number of adults within their child-bearing years diagnosed with, treated for, and surviving colorectal cancer (CRC), reproductive health concerns stand as an unmet care need among adults ages 18 to 49 years with CRC (early-onset CRC) and their families. This is because there is a paucity of prospective data to objectively measure the deleterious effects of CRC and its therapies on fertility and sexual health over time within this patient population. Given the unexplained, rising incidence of early-onset CRC over the last decades, the time is now for us to address these unmet fertility and sexual health care needs in order to improve outcomes within this growing population of reproductive age CRC survivors. Thus, this study is specifically designed to address a long-standing unmet need and achieve its overarching goal: to identify changes in gonadal function caused by CRC treatments and investigate psychosocial dimensions of sexual health and fertility-after a diagnosis of early-onset CRC. We will use validated PROM IS sexual function and satisfaction (SexFS), PROMIS-29 core health, lifestyle-related and reproductive health questionnaires, and qualitative interviews (Aim 1) to prospectively define the psychological dimensions of reproductive health at diagnosis, treatment and surveillance timepoints; as well as changes in these measures over time. This will inform the highest reproductive health concerns and needs specifically for early-onset CRC patients at uniform timepoints across the cancer care continuum. We will then use fasting blood samples (Aim 2) and detailed clinical and treatment data that are collected in parallel to prospectively quantify the impact of CRC therapies on gonadal function at three uniform study timepoints. Both specific aims utilize the same study population--the PREserving Fertility After Colorectal CancEr (PREFACE) Study cohort that is enrolling a total of 220 newly-diagnosed CRC patients between ages 18 and 49 years at Vanderbilt-Ingram Cancer Center. All laboratory assays in Aim 2 will be conducted using FDA-approved clinical immunoassays for AMH, estradiol, FSH, SHBG, LH, DHEAS, inhibin B, testosterone, DHT, and androstenedione in a CUA-accredited and CDC-certified laboratory. Overall, this study is conceptually innovative in that our cohort pairs standardized, fasting blood collection with robust sexual health, fertility, reproductive history, menstrual patterns, sociodemographic, exposures, and quality of life data, and is 11-fold larger than previous fertility-related studies in early-onset CRC. This project will generate crucial new data from a unique cohort and is statistically powered to drive significant advances toward concordant reproductive health care assessment and physical/psychosocial support strategies specific to CRC patients of reproductive age. Our findings will lead to incorporating reproductive health care in the clinical management of early-onset CRC, and ultimately improve clinical outcomes specifically for this patient population.

总结 尽管在生育年龄的成年人中，有许多人被诊断出患有结肠直肠癌（CRC），接受治疗并存活下来，但生殖健康问题仍然是18至49岁的CRC（早发性CRC）成年人及其家庭的未满足护理需求。这是因为缺乏前瞻性数据来客观衡量CRC及其治疗对该患者人群生育力和性健康随时间推移的有害影响。鉴于过去几十年来早发性CRC的发病率不明原因地上升，现在是我们解决这些未满足的生育和性健康保健需求的时候了，以改善这一不断增长的育龄CRC幸存者人口的结局。因此，这项研究是专门设计来解决一个长期未满足的需求，并实现其总体目标：确定由CRC治疗引起的性腺功能的变化，并调查性健康和生育能力的心理社会方面-在诊断为早发性CRC后。我们将使用经验证的PROM IS性功能和满意度（SexFS）、PROMIS-29核心健康、生活方式相关和生殖健康问卷以及定性访谈（目标1），前瞻性地定义诊断、治疗和监测时间点生殖健康的心理维度;以及这些指标随时间的变化。这将在整个癌症护理连续体的统一时间点为早发性CRC患者提供最高的生殖健康问题和需求。然后，我们将使用空腹血液样本（目标2）和平行收集的详细临床和治疗数据，在三个统一的研究时间点前瞻性量化CRC治疗对性腺功能的影响。这两个特定的目标都使用了相同的研究人群-结直肠癌后生育力保护（PREFACE）研究队列，该队列在范德比尔特-英格拉姆癌症中心招募了220名年龄在18岁至49岁之间的新诊断CRC患者。目标2中的所有实验室试验将在经CUA认证和CDC认证的实验室中使用FDA批准的AMH、雌二醇、FSH、SHBG、LH、DHEAS、β-氨基丁酸B、睾酮、DHT和雄烯二酮临床免疫测定法进行。总的来说，这项研究在概念上是创新的，因为我们的队列将标准化的空腹血液采集与强大的性健康，生育，生殖史，月经模式，社会人口统计学，暴露和生活质量数据配对，并且比以前的早发性CRC生育相关研究大11倍。该项目将从一个独特的队列中生成关键的新数据，并具有统计学动力，以推动针对育龄CRC患者的协调生殖保健评估和身体/心理支持策略的重大进展。我们的研究结果将导致将生殖健康护理纳入早发性CRC的临床管理，并最终改善该患者人群的临床结局。