Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Endometrial Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

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 Neoplasms

Uterine Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Female patients with high grade OC (advanced or metastatic epithelial ovarian, fallopian tube and primary peritoneal cancer):

* with newly diagnosed FIGO stage IIb-IV OC who are starting systemic treatment, independent of the treatment intention (adjuvant/curative or palliative) or
* with recurrent/relapsed disease, who received any previous systemic anti-tumor treatment and who are now starting their systemic treatment for first recurrent/relapsed disease.

Female patients with locally advanced and inoperable or metastatic EC (FIGO stage III-IV) who are starting systemic first-line therapy.

Physician's choice according to patient's needs.

iOMEDICO AG

Thomas Decker, Prof.Dr.

Ingolf Juhasz-Böss, Prof.Dr.

Elmar Stickeler, Prof.Dr.

Dirk Watermann, Prof.Dr.

Anja Welt, Dr.

Achim Wöckel, Prof.Dr.

The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with advanced or metastatic ovarian cancer (OC) or advanced or metastatic endometrial cancer (EC) in Germany.

SMARAGD is a national, prospective, open-label, longitudinal, non-interventional multicenter cohort study (tumour registry platform) to describe treatment in routine clinical practice of ovarian, fallopian tube, primary peritoneal and endometrial patients in routine care in Germany.

The registry will follow patients for up to three years with the aim to identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented.

Health-related quality of life (HRQoL) will be evaluated for up to three years.

All patients will be asked to give additional informed consent agreeing that their routinely collected tumor samples could be used for further translational research. For the decentralized biobank, pathological samples will remain with the local pathologist until scientific translational question arise. Future translational research projects that will develop during the project will be described in detail in independent research proposal and reviewed by an ethics committee.

Registry Platform Ovarian and Endometrial Cancer

SMARAGD - Clinical Research Platform on Ovarian, Fallopian Tube, Primary Peritoneal and Endometrial Cancer Treatment and Outcomes

Documentation of anamnestic data and therapy sequences.

Documentation of response rates per line of treatment.

Documentation of progression-free survival per line of treatment.

Documentation of overall survival per line of treatment.

Functional Assessment of Cancer Therapy - Ovarian (FACT-O), a 39 item questionnaire covering Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being and Ovarian Cancer Subscale

Functional Assessment of Cancer Therapy - Endometrial (FACT-En), a 43 item questionnaire covering Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being and Endometrial Cancer Subscale

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Breast Neoplasms

Death

Breast Diseases

Skin Diseases

After the screening procedure confirm eligibility to participate in the research study. Participants will be randomized into one of two study groups;

-- Standard oncology care with palliative care.

After the screening procedure confirm eligibility to participate in the research study. Participants will be randomized into one of two study groups;

-- Standard oncology care

Patients randomized to the intervention will receive collaborative care from palliative care and oncology for the remainder of their illness. The initial five visits with palliative care will be conducted in accordance with the study specific clinical practice guidelines and occur at least monthly.

Palliative and Oncology Care

Patients randomized to oncology care alone will continue to receive routine care identical to what they would have received if they had not participated in the trial. Either patients or their oncologists can request palliative care consultation at any point in time.

Standard Oncology Care

Jennifer Temel, MD

The purpose of this research study is to test a new way to deliver oncology and palliative care for patients with metastatic breast cancer.

* The goal of this study is to test a model where oncology and palliative care work together to care for participants with metastatic breast cancer who were recently admitted to the hospital or have new or worsening cancer involving their brain or the fluid around the brain or spinal cord.
* The investigators are studying whether participants who receive care from both teams have better communication about their care and improved quality of life and mood compared to those receiving care from only their oncologists.

The purpose of this randomized clinical trial is to conduct a randomized trial testing the impact of the collaborative palliative and oncology care model or standard oncology care models among patients with poor prognosis metastatic breast cancer. Participants assigned to the intervention arm will participate in a series of structured palliative care visits, following tailored clinical practice guidelines previously developed for patients with metastatic breast cancer.

This research study tests whether or not the earlier introduction of a team of clinicians that specialize in the lessening (palliation) of symptoms and addressing quality of life concerns may improve the end-of-life care, quality of life, and mood of women with poor prognosis metastatic breast cancer.

Palliative care is a specific type of medical care given to patients to improve their pain and other symptoms like fatigue, and to support patients and their families as they cope with their illness. Palliative care includes physicians and advanced practice nurses who have been specifically trained in how to help patients with serious illness.

Increasingly, the role of palliative care has been shown to benefit patients when introduced early in the disease trajectory. For example, in patients with metastatic (or spread) lung cancer, early involvement of palliative care improves patients' quality of life and mood. Patients with some metastatic cancers, like breast cancer, have an unpredictable disease trajectory, which makes it difficult to determine the best time to introduce palliative care services.

Palliative And Oncology Care Model In Breast Cancer

A Collaborative Palliative and Oncology Care Model for Metastatic Breast Cancer

Compare differences in rate of documentation of end of life care preferences (Yes documented vs. No)

Examine patient report of end of life care preferences with their clinician using the following item: "have you and your doctors discussed any particular wishes you have about the care you want to receive if you were dying?" Although patients complete this measure repeatedly during the course of the study, the investigators will use the final assessment either prior to death or at six months follow-up (whichever comes first) for this analysis.

Compare patient-reported quality of life between the two study arms at weeks 6, 12, 18, and 24.

Compare patient-reported depression symptoms between the two study arms at weeks 6, 12, 18, and 24.

Compare patient-reported anxiety symptoms between the two study arms at weeks 6, 12, 18, and 24.

Examine differences in rates of chemotherapy administration during the last 3, 7, and 14 days of life between the two study arms

Examine difference the in rates of hospice utilization between the two study arms.

Examine difference in hospice length-of-stay between the two study arms.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Registry Platform Ovarian and Endometrial Cancer	NCT05129969	Ovarian Cancer Endometrial Can... Ovary Neoplasm Endometrial Neo... Carcinoma, Ovar... Carcinoma Neoplasm, Ovari...	Physician's cho...	18 Years -	iOMEDICO AG
Registry Platform Ovarian and Endometrial Cancer	NCT05129969	Ovarian Cancer Endometrial Can... Ovary Neoplasm Endometrial Neo... Carcinoma, Ovar... Carcinoma Neoplasm, Ovari...	Physician's cho...	18 Years -	iOMEDICO AG
Palliative And Oncology Care Model In Breast Cancer	NCT02730858	Metastatic Brea...	Palliative and ... Standard Oncolo...	18 Years -	Massachusetts General Hospital
Palliative And Oncology Care Model In Breast Cancer	NCT02730858	Metastatic Brea...	Palliative and ... Standard Oncolo...	18 Years -	Massachusetts General Hospital

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