Experimental group receiving a couple-based intervention

A control group that receives same but delayed couple-based intervention

Three face-to-face therapeutic conversations and an optional web-based evidence based information (about sexual consequences of cancer treatment)

Couple-based intervention and and evaluation of effectiveness in increasing adjustment of sexuality and intimacy

Ása Þórisdóttir, PhD

The main purpose of the doctoral study is to better understand the experience of cancer diagnosis and treatment in how it effects sexuality and intimacy of the female cancer patient and her partner.

With this increased understanding, an intervention, comprised of therapeutic interventions with the couple, will be conducted and assessed on how it affects the couple's general well-being and recovery of the sexual and intimate relationship.

The intervention consists of three therapeutic conversations, based on the Illness Beliefs model in family nursing, and an optional web-based evidence based information. The aim of the intervention is to support the facilitating beliefs of the couple in adapting to changes in intimacy and identify constraining beliefs. In the first session an emphasis is on creating an optimal context for changing beliefs by building good therapeutic relationship and to invite them to share their experience, giving them the opportunity to voice their own concerns and reflect on how their situation effects their intimate relationship. In the second session, the couple take a closer look at what they themselves deem important in adjusting to changes in their intimate relationship. In both sessions information about the possible sexual side effects of treatment will be offered as needed and evidence based, optional web-based information on practical solutions will be provided. In the booster-session, the couple will assess how they have been adjusting in their intimate relationship and any positive changes that have occurred will be accentuated.

Females (hetrosexual, homosexual) and their partners.

Development of Therapeutic Conversations With Females Diagnosed With Cancer and Their Partners

Development of Therapeutic Conversations With Females Diagnosed With Cancer and Their Partners: Evaluation of Effectiveness in Adjustment of Sexuality and Intimacy

This questionnaire is a survivor self-report that screens for sexual concerns after cancer.

This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.

The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).

he instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).

Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.

Landspitali University Hospital

Erla Kolbrún Svavarsdóttir

Professor

Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

For the group allocated with exercise, high intensity circuit training (HICT) of three supervised sessions per week for 20-30 mins will be given. HICT commenced after 10 mins low to moderate intensity warm up and after completing session ended with 10 mins cool down. Intensity of exercise will be measured on borg rating of perceived exertion (RPE). Perceived exertion is how hard you feel like your body is working. Although this is a subjective measure your exertion rating based on a 0 to 10 modified borg rating scale may provide a fairly good estimate of your actual heart rate during physical activity. 0 perceiving "no exertion at all" to 10 perceiving a "maximal exertion" of effort. A moderate intensity activity will be at 3-5 perceiving "somewhat hard", similarly 6-10 will be perceived as high intensity activity.

For the group allocated with intermittent fasting, a time restricted feeding (TRF) methodology will be administered. The Fasting protocol will begin with a 12-hour eating window (12:12) and will gradually go down to 8 hours eating window over a period of 8 weeks (16:8).

The group allocated with both exercise and intermittent fasting will be provided with both HICT for three sessions per week and 8 hours' time restricted eating.

High Intensity circuit training consisting of circuits of high intensity exercises and progressed up to 8 weeks will be provided.

High Intensity Circuit training (HICT)

Time restricted feeding will be used in which the intervention will begin with a 12:12 window leading to a 16:8 IF protocol.

Intermittent Fasting (IF)

The participants will follow both HICT and IF for 8 weeks.

Combination of HICT and IF

Imran Amjad, PhD

Sarah Ehsan, PP-DPT

Hafsa Javed, DPT

The goal of this randomized controlled trial is to compare the effects of High intensity circuit training, Intermittent Fasting, and their combination on PCOS morphology, Anthropometrics, clinical hyperandrogenism and body image concerns in females with PCOS.

Participants will be divided into three groups who will receive High intensity circuit training, Intermittent fasting and their combination. The outcomes will be PCOS morphology, anthropometrics', clinical hyperandrogenism and body image concerns.

Effects of HICT and Intermittent Fasting on PCOS

Effects of High Intensity Circuit Training and Intermittent Fasting on Polycystic Ovarian Syndrome

Changes from baseline PCOS morphology on the ultrasound will be done by calculating the number of follicles and measuring follicle size. For this purpose, ultrasound imaging is the best option as it is both harmless and inexpensive. PCOS is considered if on ultrasound imaging there are 12 or more than 12 follicles in the ovary and has size of 2-9 mm or volume of 10 cm 3 .

Changes from baseline Weight (kg) will be measured by weight scale while height (ft) will be measured by stadiometer. BMI will be calculated by dividing your weight in kilograms (kg) by your height in meters squared (m 2 ). Waist Circumference (WC) will be measured in centimeters, between the costal margin and the pelvic brim, and Hip Circumference (HC) will be measured in cm at the level of the symphysis pubis by inches tape.

Changes from baseline Modified Ferriman Gallwey (mFG) score will be used to assess the hirsutism as a measure of clinical hyperandrogenism.

Changes from baseline Body Image concerns will be measured using The BSQ which is a self-reported measurement of the body shape concerns designed for women to measure concerns about body image problems.

Riphah International University

Infections

Rare Diseases

Uterine Cervical Neoplasms

Communicable Diseases

Persistent Infection

Carcinoma

Carcinoma in Situ

Uterine Cervical Dysplasia

Uterine Cervical Diseases

Uterine Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Precancerous Conditions

Disease Attributes

Cervical Intraepithelial Neoplasia

All Drugs and Chemicals

Gastrointestinal Agents

Vaccines

Aluminum Hydroxide

Aluminum sulfate

Participants in this arm have received 3 doses of HPV 16/18 bivalent vaccine that contains 40μg HPV 16 virus-like particle antigen and 20μg HPV 18 virus-like particle antigen adsorbed in alum-adjuvant.

Participants in this arm have received 3 doses of HEV vaccine that contains 30μg HEV virus-like particle antigen adsorbed in alum-adjuvant.

The bivalent HPV-16/18 vaccine was a mixture of two aluminum hydroxide adjuvant-absorbed recombinant L1 VLPs of HPV-16 and HPV-18 expressed in E. coli. A 0.5 ml dose of the bivalent HPV test vaccine comprised 40 μg of HPV-16 and 20 μg of HPV-18 L1 VLPs absorbed with 208 μg of aluminum adjuvant

Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)

Chao Zhao, Doctor

Ting Wu, Ph. D.

The 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.

This is a follow-up study that is based on phase III clinical study of a recombinant human papillomavirus 16/18 bivalent vaccine in females aged 18-45 years (Unique Protocol ID: HPV-PRO-003, Identifiers: NCT01735006). The investigators will recruit people who have participated in phase III clinical study on Hebei Province before and to evaluate the durability of protection of the bivalent HPV vaccine on 90m and 114m after dose 1.

The Durability of Protection Study of a Recombinant HPV 16/18 Bivalent Vaccine in Female

The Durability of Protection Study of A Bivalent Human Papillomavirus (Type 16, 18) Recombinant Vaccine (E.Coli) in Healthy Women Aged 18 to 45 Years

To observe the number of Subjects With Histopathologically-confirmed CIN2+ and/or VIN2+ and/or VaIN2+ Associated With HPV-16 and/or -18 Cervical Infection on 90m and 114m after dose 1

To detect the HPV16 and HPV18 DNA on the gynecological specimens ( Cervical exfoliated cell specimens and biopsy specimens) collected from the subjects

Xiamen Innovax Biotech Co., Ltd

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

Jun Zhang

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Chronic Graft Versus Host Disease

8-week group and individual mindfulness training and practice

Participants attend seven 1-hour group mindfulness sessions each week and a 1/2 day retreat, with three sessions in-person and six sessions remote, led by a mindfulness interventionist. Additionally, participants will be encouraged to engage for at least 30 minutes per week in asynchronous mindfulness activities through a web-based program to increase exposure to mindfulness practices beyond group sessions.

Mindfulness

Lisa Tussing, PhD

Alana Biggers, MD

Lisa Tussing-Humphreys, PhD

Many neighborhoods in Chicago experience daily exposure to stressors including economic inopportunity and violent crime in public spaces. There is mounting evidence that chronic psychosocial stress can facilitate carcinogenesis by modulating the gut microbiome and immune system. The proposed research aims to study the practice of mindfulness to mitigate CPS and reduce colorectal cancer risk factors among Black American women at elevated risk.

Chronic stress can directly and indirectly promote carcinogenesis through immune, metabolic, and microbial pathways. Our overarching hypothesis is that reducing chronic stress will have important implications for colon cancer risk reduction among vulnerable and high-risk populations. A promising approach for reducing chronic stress is mindfulness practices. Mindfulness is a meditation-based technique to achieve a state of mind used to experience higher awareness or consciousness. We propose to pilot test an 8-week Mindfulness intervention delivered in a hybrid format (synchronous and asynchronous sessions) among 40 Black females at elevated risk of colon cancer, who reside in vulnerable communities and who report moderate to high perceived stress. At baseline and post-intervention, participants will provide blood and stool undergo body composition analysis, and complete mood and lifestyle-related surveys. The specific aims are to: test the feasibility and acceptability of the intervention and evaluate the preliminary effect on stress and weight, fasting glucose, inflammation markers, and the gut microbiome - risk markers and risk pathways associated with colon tumorigenesis. While relieving social stressors is the paramount goal, addressing chronic stress at the individual level is achievable now, with implications for CRC risk reduction. If successful, data generated here will serve in developing a fully powered trial to test if MBSR is efficacious for CRC risk reduction among high-risk vulnerable populations in Chicago.

Targeting Chronic Stress for Reducing Risk Factors for Colorectal Cancer

Mindfulness and CRC Risk Factor Reduction: Targeting Chronic Stress For Colorectal Cancer Risk Factor Reduction A Pilot Feasibility Study Among Vulnerable At-Risk Black Females

weight in kg divided by height in meters squared

% body fat and visceral body fat area from whole body DEXA

From serum measured via mass spectrometry

From serum - total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides

easible if ≥ 30% of those approached enroll at a minimum rate of 1-3 women/week for each wave and ≥ 80% of women enrolled are retained with complete data collection at both assessment time-point

The intervention will be deemed acceptable if women attend ≥ 80% of the Mindfulness group sessions, engage with ≥ 80% of the asynchronous Mindfulness content and score ≥ 16 on the acceptability survey.

University of Illinois at Chicago

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Micronutrients

Mineral

Selenium

Antioxidants

Protective Agents

Trace Elements

Selenium Supplement

Placebo: 900 Supplement: 900 Diet modification: 900 Observation: 900

Diet modification: 1100 Observation: 1100

Patients from this group will receive selenium supplement to achieve optimal selenium level

Selenium supplementation or placebo treatment

Patients from this group will have modified diet over the course of the study. Diet modification is aimed to lower selenium concentration in blood.

Diet modification

In this group patients will receive supplement, placebo or diet modification. The goal is to raise selenium concentration in blood

Selenium supplementation or placebo treatment and diet modification

Jan Lubiński, MD, PhD

Cezary Cybulski, MD, PhD

Jacek Gronwald, MD, PhD

Tomasz Huzarski, MD, PhD

Anna Jakubowska, MD, PhD

Antoni Morawski, PhD

Ewa Stachowska, PhD

Edyta Balejko, PhD

Karolina Ertmańska, PhD

Hypothesis to be tested:

Oral supplementation or diet modifications of selenium to a specified range will be effective in reducing the risk of developing cancer of any type in women with high risk of breast cancer, as compared to placebo.

Primary Objective

• To determine the efficacy of oral daily supplementation or diet modification of selenium to an optimal level compared to placebo, in reducing the incidence of any cancers in an at risk population of women over the 60 months of the study.

Secondary Objectives

* To determine the efficacy of oral daily supplementation or diet modification of selenium to an optimal level compared to placebo, in reducing the incidence of breast cancer in an at risk population of women over the 60 months of the study.
* To explore the relationship between the effects of study supplement or diet modifications on cancer risk and genetic factors.

The study will have 7000 participants. All the measurements will be performed via blood tests.

Supplementation of selenium or diet modification will be effective in reducing the risk of developing breast cancer in women with high risk, as compared to placebo.

The null hypothesis assumes no significant differences between the supplementation and placebo groups. The alternative hypothesis assumes that patients with high risk of breast cancer in supplementation or diet modification group with optimal selenium level will have significantly reduced risk of developing cancer in relation to the placebo group with selenium deficiency. The comparison of disease-free survival time intervals is best covered by Cox Regression and is represented by a Kaplan-Meier survival curve tested by log- rank test.

The comparison of proportions of diseased and healthy subjects in the supplementation arm with respect to the placebo arm is best attempted using the Fisher Exact Test. Graphical representation should be based on bar plots for percentages and/or raw numbers, or a similar representation.

The selected randomization method is block randomization with randomly chosen blocks sizes.

Randomization must take place before 120 days after the Screening Visit (Day 0). After confirmation that the patient meets all eligibility criteria for the study, the patient will be randomly assigned (1:1) to either placebo or supplementation group. Patients with selenium deficiency can choose between diet modification and supplementation group.

The last step of randomisation is the blinding/assigning procedure - connecting randomization numbers with placebo or supplement packages numbers and assigning them to the subjects. All SELINA personnel, participants and clinicians will be blinded to the treatment allocation; only the Statistical Center will have the possibility to unblind the data.

Prevention of Female Cancers by Optimization of Selenium Levels in the Organism.

Prevention of Females Malignancies in Families With Hereditary Breast Cancer by Personalized Optimization of Se Levels in the Organism.

We still did not collect all the required participants. It is hard to tell that the data could be useful later on.

Cancer diagnosis will be determined by routine clinical management and confirmed by central pathology review. Cancer-free survival is defined as the period of time between randomization and diagnosis of cancer, or - for patients who do not develop cancer - the period of time between randomization and last contact or death unrelated to cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Development of Therapeutic Conversations With Females Diagnosed With Cancer and Their Partners	NCT03936400	Cancer	Couple-based in...	18 Years -	University of Iceland
Effects of HICT and Intermittent Fasting on PCOS	NCT06302166	Polycystic Ovar... PCO	High Intensity ... Intermittent Fa... Combination of ...	18 Years - 35 Years	Riphah International University
The Durability of Protection Study of a Recombinant HPV 16/18 Bivalent Vaccine in Female	NCT04969445	Cervical Intrae... Cervical Cancer Vaginal Intraep... Vulvar Intraepi... Persistent Infe...	Recombinant Hum...	26 Years - 54 Years	Xiamen University
Targeting Chronic Stress for Reducing Risk Factors for Colorectal Cancer	NCT06323421	Mindfulness Colon Cancer Females	Mindfulness	45 Years - 65 Years	University of Illinois at Chicago
Prevention of Female Cancers by Optimization of Selenium Levels in the Organism.	NCT04014283	Breast Neoplasm...	Selenium supple... Diet modificati... Selenium supple...	21 Years -	Read-Gene S.A.

Spots Global Cancer Trial Database for females

Every month we try and update this database with for females cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for females

Every month we try and update this database with for females cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for females cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.