Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Uterine Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Uterine Diseases

Ovarian Cancer

Participants will receive instruction on awareness meditation, breathing and relaxation, and awareness meditation. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery.

Participants will receive caring attention. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery.

Given information about mindful movement and breathing

Informational Intervention

Questionnaire Administration

Telephone-Based Intervention

Stephanie Sohl

This trial studies how well two different supportive programs work in supporting optimal recovery in participants undergoing gynecological surgery. Supportive programs use different methods for helping participants cope with the surgical experience including gentle movements, counseling, writing, or relaxation techniques, and may help improve participants' well-being after gynecological surgery.

PRIMARY OBJECTIVES:

I. To calculate recruitment, adherence, assessment completion, and retention rates.

SECONDARY OBJECTIVES:

I. Document the frequency of adverse events. II. Assess descriptive data on proposed outcomes (i.e., pain, sleep disturbances, psychological distress) for the next phase of study.) III. Qualitatively assess acceptability to guide future study planning.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I (MINDFUL MOVEMENT AND BREATHING \[eMMB\]): Participants will receive instruction on awareness meditation, breathing and relaxation, and awareness meditation. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery.

GROUP II (ATTENTION CONTROL \[AC\]): Participants will receive caring attention. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery.

Supportive Programs for Supporting Optimal Recovery in Participants Undergoing Gynecological Surgery

Support for Optimal Recovery Following Gynecologic Surgery Study (SOARING)

Will provide quantitative data to guide future study planning. Will calculate 95% confidence intervals for each of the feasibility measures to determine the range of estimates that are consistent with the data. Will track the number of screened participants, those who are eligible, and the percent who agree to participate. For those not meeting the eligibility criteria, reasons will be summarized. The proportion of participants and corresponding 95% CI for participants who participated in each group will be computed. Will use one-sample tests of binomial proportions to compare the recruitment, adherence, and retention rates to the hypothesized values of 50%, 70% and 70%, respectively.

Will provide quantitative data to guide future study planning. Will calculate 95% confidence intervals for each of the feasibility measures to determine the range of estimates that are consistent with the data. Will track the number of screened participants, those who are eligible, and the percent who agree to participate. For those not meeting the eligibility criteria, reasons will be summarized. The proportion of participants and corresponding 95% CI for participants who participated in each group will be computed.

Baseline analyses will include descriptive statistics of pain, background characteristics and other possible confounding variables by intervention group. The primary goal of the statistical analysis of these measures for this Aim will be to estimate standard deviations (SD) for use in future studies. A change in pain intensity between two or more time points (baseline, 2 weeks and 4 weeks) will be reported.

The PROMIS assesses pain on a numeric rating scale from 0 (no pain) to 10 (worst imaginable pain)

The affective dimension of pain will be assessed with one item on a scale from 0 (not bad at all) to 10 (the most unpleasant feeling possible for me). A higher score represent a higher affective dimension of pain for the participant. A change in score between two or more time points (baseline, 2 weeks and 4 weeks) will be reported.

Baseline analyses will include descriptive statistics of pain, background characteristics and other possible confounding variables by intervention group. The primary goal of the statistical analysis of these measures for this Aim will be to estimate standard deviations (SD) for use in future studies. Additional analyses will include fitting mixed analysis of covariance (ANCOVA) models (adjustment for baseline) to model the trajectory of pain by time and group accounting for the repeated measures on a subject. Score range is 0-100 with a higher score representing greater pain interference for the participant. A change in score between two or more time points (baseline, 2 weeks and 4 weeks) will be reported.

Baseline analyses will include descriptive statistics of pain, background characteristics and other possible confounding variables by intervention group. The primary goal of the statistical analysis of these measures for this Aim will be to estimate standard deviations (SD) for use in future studies. Score range is 0-100 with higher scores representing a greater sleep disturbance for participants. A change in score between two or more time points (baseline, 2 weeks and 4 weeks) will be reported.

Baseline analyses will include descriptive statistics of pain, background characteristics and other possible confounding variables by intervention group. The primary goal of the statistical analysis of these measures for this Aim will be to estimate standard deviations (SD) for use in future studies. Score range is 0-100 with the higher score representing greater depression in the participants. A change in score between two or more time points (baseline, 2 weeks and 4 weeks) will be reported.

Baseline analyses will include descriptive statistics of pain, background characteristics and other possible confounding variables by intervention group. The primary goal of the statistical analysis of these measures for this Aim will be to estimate standard deviations (SD) for use in future studies. Score range is 0-100 with a higher score presenting a greater level of anxiety in the participants. A change in score between two or more time points (baseline, 2 weeks and 4 weeks) will be reported.

Will describe any adverse events reported as frequencies.

National Cancer Institute (NCI)

Wake Forest University Health Sciences

Participants will receive instruction on awareness meditation, breathing and relaxation, and awareness meditation. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery.

Informational Intervention: Given information about mindful movement and breathing

Questionnaire Administration: Ancillary studies

Group I (eMMB)

Participants will receive caring attention. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery.

Questionnaire Administration: Ancillary studies

Telephone-Based Intervention: Receive caring attention phone call

Group II (AC)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Meg O'Mara

Of the 14 randomized to intervention for Group I, 1 person was removed from the study following randomization (and prior to filling out any surveys at baseline) due to ineligibility. For Group I and II, not all participants completed requirements of retention to be analyzed for the study.

Percentage of Participants Retained in the Study

Of the 14 randomized to intervention for Group I, 1 person was removed from the study following randomization (and prior to filling out any surveys at baseline) due to ineligibility. For Group I and II, not all participants completed requirements of adherence to be analyzed for the study.

Percentage of Participants That Were Adhered to the Intervention

Baseline

2 weeks change in score

4 weeks change in score

Group I eHealth Mindful Movement and Breathing (eMMB)

Group II Attention Control (AC)

Investigators discovered recently that there had been a protocol deviation such that a participant had had their surgery PRIOR to filling out the baseline survey. That participant's baseline data had to be removed from our analyses and revised data has been submitted. Not all participants provided evaluable data for analysis.

Change in Pain Intensity Per Patient Reported Outcomes Measurement Information System (PROMIS)

Change in Affective Dimension of Pain

Change in Pain Interference Per PROMIS Measure

Change in Sleep Disturbances Per PROMIS Sleep Disturbance Short-form

2 weeks score change

4 weeks score change

Change in Psychological Distress Per PROMIS Depression

Change in Psychological Distress Per PROMIS Anxiety

Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

Overall Study

Uterine Cervical Neoplasms

Uterine Cervical Diseases

Eligible women residing in the Central Denmark Region will be assigned to intervention group. Women in the intervention group receive an invitation for HPV-based cervical cancer screening by attending either 1) GP-based screening or 2) HPV self-sampling. The self-sampling kit includes the dry Evalyn brush self-sampling device (Rovers Medical Devices B.V, Oss, Netherlands), written and picture-based user instructions on how to collect and mail the self-sample, and a prestamped return envelope addressed to the Department of Pathology, Randers Regional Hospital.

Eligible women residing in the other five Danish regions (North, Central, South, Zealand and Capital ) will be assigned to control group. Women in the control group will receive usual care, which for 65-69 year-old women is opportunistic cervical cancer screening at the GP

Women in the intervention group will receive an invitation for HPV-based cervical cancer screening by either 1) scheduling an appointment for a cervical cytology by the GP or 2) collect a cervico-vaginal sample themselves in their own home using a self-sampling kit.

GP-based screening or HPV self-sampling

Mette Tranberg, Post doc PhD

Mette tranberg Nielsen, phd

Berit Andersen, MD, PhD

Mette T Tranberg, post doc phd

This study evaluates the effect and feasibility of expanding the target population in the Danish cervical cancer screening program to include women aged 65 to 69 years. The study also evaluates if HPV self-sampling constitutes an appropriate screening method among older women.

The study is a nationwide population-based prospective cohort study embedded in the routine cervical cancer screening program in the Central Denmark Region. The study includes all 65 to 69 years old Danish women with no record of a cervical cytology sample or screening invitation within the last five years. Furthermore, the women are not registered as ineligible for screening, eg due hysterectomy. Eligible women residing in the Central Denmark Region are allocated to the intervention group (n=20,000), while women residing in the other four Danish regions are allocated to the control group receiving standard care (n=71,500), which for this group is low-level opportunistic screening at the general practitioner (GP). The intervention group are invited for HPV-based screening by the GP or to request a self-sampling kit.

Only women are offered cervical cancer screening

Offering Cervical Cancer Screening to Older Women

Reducing the Burden of Cervical Cancer Among Older Women by Expanding the Screening Age and Offering HPV Self-sampling

Participation rate, eg the roportion of targeted women participating by GP-based screening or self-sampling

The proportion of HPV-positive self-samplers who attend appropriate follow-up by their GP for onward referral

Screening history of participants and non-participants in the intervention group

Proportion of abnormal cytological findings between the intervention and control group is compared

Proportion of abnormal histological findings between the intervention and control group is compared

The incidence rate of cervical cancer developed within 5 year is compared between the intervention and control group

The mortality rate of cervical cancer developed within 5 year is compared between the intervention and control group

University of Aarhus

Leiomyosarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Sarcoma

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Anti-Infective Agents

Gemcitabine

Docetaxel

Dexamethasone

Doxorubicin

Liposomal doxorubicin

Dexamethasone acetate

Antimetabolites

Tubulin Modulators

Antimitotic Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Gemcitabine 900 mg/m2 IV over 90 minutes days 1 and 8 Docetaxel 75 mg/m2 IV day 8 (pre-medication dexamethasone 4-8 mg p.o. bid for 3 days, starting 12-24 hours prior to docetaxel). Doxorubicin 60 mg/m2 IVP every 21 days for 4 cycles (recommend use of central venous catheter access).

gemcitabine, docetaxel, doxorubicin

Martee L. Hensley, MD

The purpose of this trial is to study the benefits of giving chemotherapy to women after they have had surgical resection of their primary disease and have no evidence of disease remaining(known as adjuvant therapy). The major objective of this study is to determine the progression free survival. The goal is to prevent relapse or recurrence of their uterine leiomyosarcoma.

Patients with a diagnosis of early-stage uterine leiomyosarcoma have a 70% chance of relapse or recurrence of their disease. Patients enrolled in this trial will receive 4 cycles of gemcitabine and docetaxel followed by 4 cycles of adriamycin. Following completion of chemotherapy, they will be have repeat imaging at regular intervals to monitor for disease recurrence along with periodic clinical evaluations.

Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma

Adjuvant Treatment of High Risk Uterine Leiomyosarcoma With Gemcitabine/Docetaxel Followed by Doxorubicin: A Phase II Trial

Unacceptable toxicity is defined as grade 3 or 4 non-hematologic toxicity events that are considered to be treatment-related, excluding alopecia and fatigue.

AJCC Stage I: No serosal involvement AJCC Stage II: No serosal involement AJCC Stage III: Serosal only

Mitotic rate is measured in mitoses per 10 high-power fields

Stage I: confined to the uterine corpus Stage II: confined to corpus and cervix Stage IIIA: serosa involvement only (disease could involve the uterine serosa, but patients must have had no other evidence of local spread)

Sarcoma Alliance for Research through Collaboration

Women Treated With Adjuvant Regimen for High Risk Uterine LMS

Age, Categorical

Research Project Manager

The primary endpoint is progression-free survival time, with progression defined as a patient having evidence of recurrent LMS on follow-up evaluation and CT scan. Futility monitoring will be based on the accumulating right-censored PFS time data. The monitoring rules will be based on a Bayesian model.

Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS

Tolerability/Toxicity of This Regimen

Age correlation with progression-free survival for patients on study treatment.

Correlation Between Age and Tumor Response to Treatment (PFS)

Menopausal status at diagnosis correlation with progression-free survival for patients on study treatment.

Postmenopausal

Premenopausal

Correlation Between Menopausal Status at Diagnosis and Tumor Response to Treatment (PFS)

Uterine serosal involvement correlation with progression-free survival for patients on study treatment.

AJCC Stage I

AJCC Stage II

AJCC Stage III

Correlation Between Uterine Serosal Involvement and Tumor Response to Treatment (PFS)

Mitotic rate correlation with progression-free survival for patients on study treatment.

Correlation Between Mitotic Rate and Tumor Response to Treatment (PFS)

Estrogen receptor (ER) status correlation with progression-free survival for patients on study treatment.

Positive Status

Negative Status

Only 38 of the 47 patients were evaluable

Correlation Between Estrogen Receptor (ER) Status and Tumor Response to Treatment (PFS)

Progesterone receptor (PR) status correlation with progression-free survival for patients on study treatment.

Correlation Between Progesterone Receptor (PR) Status and Tumor Response to Treatment (PFS)

1988 FIGO Stage correlation with progression-free survival for patients on study treatment.

FIFO Stage I

FIGO Stage II

FIGO Stage III

Correlation Between 1988 FIGO Stage and Tumor Response to Treatment (PFS)

Estrogen receptor (ER) or progesterone receptor (PR) positive correlation with progression-free survival for patients on study treatment.

ER or PR Positive

ER and PR Negative

Correlation Between Estrogen Receptor (ER) or Progesterone Receptor (PR) Positive and Tumor Response to Treatment (PFS)

Gemcitabine 900 mg/m2 on days 1 and 8 intravenously over 90 minutes, followed by Docetaxel 75 mg/m2 on day 8 intravenously over 1 hour.

Symptoms and General Pathology

Hyperplasia

Endometrial Hyperplasia

Endometrial Neoplasms

Bone Density Conservation Agents

Pharmaceutical Solutions

Anticoagulants

Herbal and Botanical

Tamoxifen

Hormones

Cola

Women with histological diagnosis of cancer of the endometrium (any type) undergoing hysterectomy

Women with histological diagnosis of endometrial hyperplasia (with or without atypia) undergoing hysterectomy

Healthy women undergoing hysterectomy for a benign reason

age, race, parity, body mass index, last menstrual period, menstrual cycle type, hypertension, type II diabetes, anovulation, polycystic ovary syndrome, indication for hysterectomy and smoking history. Other epidemiologic risk factors including tamoxifen exposure, history of breast cancer, current hormone therapy use, anticoagulant use, oral contraception use, family history of endometrial, breast or colon cancer.

Information about clinical risk factors for endometrial cancer and endometrial hyperplasia

* All women will undergo planned hysterectomy.
* Venous blood sample will be collected prior to surgery.
* Endometrial sampling via Pipelle device will be performed immediately prior to hysterectomy
* Endometrial biopsy from the hysterectomy specimen will be obtained under direct vision

The plasma and serum obtained from the blood samples will be analysed with ATR-FTIR and Raman spectroscopes. Spectra from both wet and dry specimens will be recorded.

All tissue samples retrieved will be placed in Phosphate Buffered Solution for transfer to the histopathology laboratory. Spectra will be collected from the fresh samples with ATR-FTIR and Raman spectroscopes. Spectral analyses will subsequently be repeated on dry samples post fixation and processing.

All tissue samples will undergo haematoxylin and eosin staining after spectral analysis for standard histopathological confirmation.

Blood and endometrial tissue sampling

Lymph nodes will be excised if recommended as part of the standard treatment for endometrial cancer.

Each node will be cut in half or in quarters, depending on size, to expose the core. Wet and dry spectral analysis will be performed, followed by staining for histopathological confirmation.

Lymph node sampling

Roberta Schiemer, MBBS

Ketankumar Gajjar, MD

The purpose of this study is to investigate the ability of vibrational spectroscopic techniques, Raman spectroscopy and Attenuated Total Reflection - Fourier Transform Infrared spectroscopy (ATR-FTIR), to accurately differentiate endometrial tissue, lymph nodes and blood samples with womb cancer or endometrial hyperplasia from healthy controls.

Womb cancer is the sixth most common cancer in women, with rising incidence worldwide. Current diagnostic strategies are time consuming, invasive and have limited accuracy, furthermore there is no population-wide screening. Treatment depends on patients' health, type of disease and spread at the time of diagnosis. Most women will be offered surgery, however the role of lymph node dissection in early stage disease remains controversial.

There is therefore a need for an objective, accurate test, able to detect pre-cancer and cancer early and able to identify metastatic node involvement, so that lymph node excision is performed only when necessary.

Attenuated Total Reflection - Fourier Transform Infrared (ATR-FTIR) spectroscopy and Raman spectroscopy are non-invasive, objective techniques that use the interaction of light within tissues to gain detailed information about the chemical composition of biological samples. These methods have shown tremendous potential for improving diagnosis and treatment of cancer.

This study aims to use Vibrational Spectroscopy to examine blood plasma and serum, endometrial biopsies via Pipelle device and pelvic/para-aortic lymph nodes for the presence of endometrial pre-cancer and cancer changes. The analyses will be performed on fresh (wet) as well as dried samples.

The ultimate goal is to develop a point-of-care test and an intra-operative tool for endometrial cancer screening and diagnosis. Such a test could speed up endometrial cancer diagnosis, reduce treatment delays and individualise patients care.

Specimens will be retained for the duration of the study

Vibrational Spectroscopy for Endometrial Cancer Diagnosis

Application of Vibrational Biospectroscopy as a Novel Diagnostic Tool in Endometrial Cancer

The primary outcome of the study will be to evaluate the correct classification of cases of endometrial cancer, endometrial hyperplasia and controls by Raman and ATR-FTIR spectral analysis, compared to histopathology as the standard of reference. The outcome will be measured with sensitivity, specificity, positive/negative predictive values and likelihood ratios.

The diagnostic accuracy will be documented for pipelle samples, endometrial samples from hysterectomy specimens, pelvic/para-aortic lymph nodes, blood serum and plasma.

Identification of the most important wavenumbers that distinguish between normal, hyperplasia and cancer

sub-analysis of segregation percentages for pre-cancerous changes (non-atypical / atypical hyperplasia) and cancer subtypes

Calculation of inter- and intra- user classification variability

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Supportive Programs for Supporting Optimal Recovery in Participants Undergoing Gynecological Surgery	NCT03681405	Ovarian Neoplas... Uterine Neoplas...	Informational I... Questionnaire A... Telephone-Based...	18 Years -	Wake Forest University Health Sciences
Offering Cervical Cancer Screening to Older Women	NCT04114968	Uterine Cervica... Uterine Neoplas... Uterine Cervica... Mass Screening	GP-based screen...	65 Years - 69 Years	University of Aarhus
Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma	NCT00282087	Leiomyosarcoma Uterine Neoplas...	gemcitabine, do...	18 Years -	Sarcoma Alliance for Research through Collaboration
Vibrational Spectroscopy for Endometrial Cancer Diagnosis	NCT05026073	Endometrial Can... Endometrial Hyp...	Information abo... Blood and endom... Lymph node samp...	18 Years - 90 Years	Nottingham University Hospitals NHS Trust
Letrozole Versus Observation in Patients With Newly Diagnosed Uterine Leiomyosarcoma	NCT00414076	Leiomyosarcoma Uterine Neoplas...	Letrozole	18 Years -	M.D. Anderson Cancer Center
Hypofractionated Radiochemotherapy	NCT06331468	Uterine Cervix ...	Cisplatin intensity modul... high-dose-rate ...	18 Years - 120 Years	University of Kentucky
Supportive Programs for Supporting Optimal Recovery in Participants Undergoing Gynecological Surgery	NCT03681405	Ovarian Neoplas... Uterine Neoplas...	Informational I... Questionnaire A... Telephone-Based...	18 Years -	Wake Forest University Health Sciences
Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma	NCT00282087	Leiomyosarcoma Uterine Neoplas...	gemcitabine, do...	18 Years -	Sarcoma Alliance for Research through Collaboration
EHealth Mindful Movement and Breathing in Improving Outcomes in Participants Undergoing Gynecologic Surgery	NCT03379376	Female Reproduc... Malignant Femal... Malignant Uteri... Ovarian Carcino... Ovarian Neoplas... Suspicious for ... Uterine Neoplas...	Questionnaire A... Supportive Care	18 Years -	Wake Forest University Health Sciences
Offering Cervical Cancer Screening to Older Women	NCT04114968	Uterine Cervica... Uterine Neoplas... Uterine Cervica... Mass Screening	GP-based screen...	65 Years - 69 Years	University of Aarhus
Niraparib in High-grade Endometrial Cancer Trial	NCT05289648	Endometrial Can... Serous Adenocar... Uterine Neoplas...	Niraparib oral ...	18 Years -	Sir Mortimer B. Davis - Jewish General Hospital

Spots Global Cancer Trial Database for uterine neoplasm