An Episodic Future Thinking Intervention to Promote Weight Loss in Breast Cancer Survivors
Anatomic Stage 0 Breast Cancer AJCC v8Anatomic Stage I Breast Cancer AJCC v822 moreThis clinical trial evaluates the use of an Episodic Future thinking Intervention to promote weight loss in breast cancer survivors. Obesity is associated with multiple negative health sequelae in breast cancer survivors. This includes an increased risk of cancer recurrence and mortality, multiple quality of life issues, and increased risk of co-morbidities. Delay Discounting is a behavioral health economic target that refers to the "discounting" of a larger benefit in the future for a smaller, more immediate reward in the present. A high delay discounting rate is correlated with poor dietary choices and sedentary lifestyle. Episodic Future Thinking (EFT) simulates positive events that may occur in one's future, engaging the science of prospection. EFT decreases delay discounting rate, resulting in healthier diet choices and weight reduction. However, valuation of the future may impact cancer survivors differently due to adjusted mortality perception and cancer-related stress. This study will determine the feasibility and preliminary efficacy of remotely delivered (smartphone application) EFT as a behavioral intervention for weight loss in breast cancer survivors. Implementation of EFT as a complementary approach to standard lifestyle interventions could lead to improvement in weight loss, food choice, and quality of life, thereby positively impacting overall health and longevity in cancer survivors.
Implementing a Virtual Tobacco Treatment for Cancer Patients in Community Oncology Practices
Carcinoma In SituCurrent Smoker3 moreThis phase II trial studies how well smoking cessation treatment plans work in tobacco-dependent cancer patients when delivered virtually as part of their cancer care in community oncology practices. Virtual information and counseling sessions may help cancer patients quit smoking.
EMBr Wave for the Reduction of Hot Flashes in Women With a History of Breast Cancer
Breast CarcinomaBreast Ductal Carcinoma In Situ2 moreThis trial studies how well EMBr Wave technology works in reducing hot flashes in women with a history of breast cancer. Hot flashes are a common symptom experienced by menopausal women. The standard treatment for hot flashes is hormone replacement therapy, however hormone replacement therapy cannot be used in women with a history of, or active, breast cancer. EMBr Wave is a personal heating and cooling device worn on the wrist. EMBr Wave may help reduce hot flash severity in women with a history of breast cancer.
Wide Excision Alone as Treatment for Ductal Carcinoma in Situ of The Breast
Ductal Carcinoma in Situ of the BreastThe purpose of this study is to determine if wide excision (surgical removal) alone is adequate treatment for small, grade 1 or 2 ductal carcinoma in situ (DCIS) of the breast.
Low Dose TamOxifen and LifestylE Changes for bReast cANcer prevenTion
BRCA MutationPALB2 Gene Mutation2 moreCirculating levels of Sex Hormone Binding Globulin (SHBG) are significantly associated with a decreased risk of breast cancer. The main aim of this clinical trial is to verify whether Low Dose Tamoxifen (LDT) increases circulating levels of SHBG more than lifestyle intervention (LI) with or without intermittent caloric restriction (ICR) after 6 months in women at increased risk of breast cancer (unaffected BRCA1-2 OR PALB2 mutation carriers; or with a >5% risk of developing breast cancer at 10 years according to the "Tyrer-Cuzick model") or with a recently resected intraepithelial neoplasia of the breast (IEN). The secondary aims are: to verify whether ICR significantly modulates primary and secondary endpoints such as Homeostasis Model Assessment (HOMA) index, immune and inflammatory markers, lipid profile, Adiponectin/Leptin (A/L) ratio, quality of life (QoL), Body mass index (BMI), fat body composition, safety and toxicity; to verify whether LDT significantly modulates secondary endpoints, such as HOMA-index, immune and inflammatory markers, lipid profile, A/L ratio, QoL, BMI, fat body composition, safety and toxicity; to investigate differences in microbiome composition by arms and the effect of changes in microbiome on QoL taking into account circulating biomarkers, cytokines, immune modulators, and inflammatory proteins in serum; to investigate MD (Mammographic Breast Density) changes by LDT vs. LI, with or without ICR. This aim will be performed in a subgroup of participants (not all the participants will undergo mammography due to younger age).
Acolbifene Versus Low Dose Tamoxifen for the Prevention of Breast Cancer in Premenopausal Women...
Breast Atypical HyperplasiaBreast Carcinoma2 moreThis phase IIA trial compares the effect of acolbifene versus low dose tamoxifen in preventing breast cancer in premenopausal women at high risk for developing breast cancer. The usual approach for patients at increased risk for breast cancer is to undergo yearly breast magnetic resonance imaging (MRI) or ultrasound in addition to yearly mammogram. Premenopausal women at very high lifetime risk for breast cancer (greater than 50%) can consider preventive removal (mastectomy) of both breasts. Premenopausal women age 35 or older with a prior diagnosis of atypical hyperplasia, lobular carcinoma in situ, or an estimated 10-year risk of greater than or equal to 3% or estimated 10-year risk of greater than or equal to 2-5 times that of the average woman (depending on age) may be advised to consider five years of standard dose tamoxifen. Standard dose tamoxifen is four times the dose used in this study. Estrogen can cause the development and growth of breast cancer cells. Acolbifene and tamoxifen blocks the use of estrogen by breast cells. This study may help researchers measure the effects of acolbifene and low dose tamoxifen on markers of breast cancer risk in mammogram imaging, breast tissue, and in blood samples.
Impact on Disease Relapse of HPV Vaccination in Women Treated With LEEP for Cervical Intraepithelial...
Cervical Intraepithelial NeoplasiaThis study evaluates the impact on disease relapse of presurgical 9-valent HPV vaccination versus placebo vaccination in women treated with LEEP (loop electrosurgical excision procedure) for CIN2+ (high grade cervical intraepithelial neoplasia) and initially invasive cervical cancer.
Anal Cancer Risk In Women
Anal CancerHuman Papilloma Virus3 moreThis is a retrospective cross-sectional study involving the analysis of Cancer Registry Data. As part of this study, cancer registration data collated by the National Cancer Registration and Analysis Service (NCRAS; the national cancer registry in England), via NHS Digital data access request service (DARS), will be analysed on all female patients aged between 25-90+ years in England with a registered diagnosis of anal and vaginal and/or vulvar and/or cervical cancer and/or high grade squamous intraepithelial lesions (HSIL) between 2001 and 2019. For these patients information on age at diagnosis, ethnicity, deprivation, performance status, stage of the cancer at diagnosis, the date of each diagnosis, the treatment received for the diagnosis and the route to diagnosis, will be analysed. Additionally, the total number of women/year (between 1995 and 2019), in England, aged between 25-90+ years with a diagnosis of anal, vulvar, vaginal and cervical cancer as well as their respective HSILs will be requested. Together this data will be used to establish the incidence of anal cancer and HSIL in women with genital cancers and/or HSILs, the progression timelines between the different pathologies, as well as identify relevant sociodemographic risk factors in this patient group.
The Durability of Protection Study of a Recombinant HPV 16/18 Bivalent Vaccine in Female
Cervical Intraepithelial NeoplasiaCervical Cancer3 moreThe primary objective of this study is to evaluate the durability of protection of Recombinant Human Papillomavirus Bivalent (Types 16,18) Vaccine administered in females aged 18-45 years.
ANAL PRECANCEROUS LESIONS IN HIGH-RISK PATIENTS.
AIN3AIN22 moreHIV-positive patients, women with a history of genital neoplasia and patients under pharmacologically immunosuppression (e.g. transplanted recipients, Crohn´s disease and Lupus) are a high-risk population for anal human-papillomavirus infection and associated complications, like anal precancerous lesions and anal squamous cell carcinoma. There is a lack of information on the prevalence of anal precancerous detected by routine colonoscopy in this population, by evaluating the squamocolumnar junction (the most susceptible area for lesions) during this procedure. Given, the increasing incidence rates of anal squamous cell carcinoma expected for the next two decades and the increase number of at-risk patients, the possible benefit of routine endoscopy in the diagnosis of anal precancerous lesions needs to be further explored.