Neoplasms

Digestive System Diseases

All Conditions

Skin and Connective Tissue Diseases

Nervous System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Blood and Lymph Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Esophageal Neoplasms

Breast Neoplasms

Melanoma

Brain Neoplasms

Head and Neck Neoplasms

Lung Neoplasms

Hematologic Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Urogenital Neoplasms

Gastrointestinal Diseases

Brain Diseases

Central Nervous System Diseases

Hematologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Esophageal Cancer

Participants who have completed primary treatment (completed chemotherapy and/or radiation and/or surgery) are eligible to participate in the study

Each participant's involvement in the study will include:

* Attending a Pre-Program Orientation which will be held a week before the first MOM Session.
* Completing 5 weekly sessions of MOM
* Completing 2 surveys; one will be given before the start of the intervention (a pre-test) and the other will be given after the last MOM Session (a post-test)

Participants will also have the option to participate in an optional Focus Group session which will occur a week after the last MOM Session ends

Participants will spend about 6 weeks in this study. If they decide to participate in the optional session, they will spend about 7 weeks in this study.

Please note, this entire Intervention will be offered online. There will be no in-person sessions or visits.

Mind Over Matter (MOM)

Michelle Ferretti, MSW, LCSW, OSW-C

The goal of this study is to learn if the Mind Over Matter (MOM) Intervention, a 5-week group program, can help Black and African American women deal with the fears, worries and sadness that often accompany cancer diagnosis and treatment. The main question this study aims to answer is:

• Whether the MOM Intervention is feasible and acceptable among Black and African American women.

We would also like to find out if:

* The MOM Intervention decreases anxiety, depression and physical symptom severity for Black and African American women.
* The MOM Intervention is culturally and linguistically appropriate, and identify barriers, strengths, and areas of improvement.

Participants will:

* Attend a Pre-Program Orientation
* Attend 5 weekly MOM Sessions
* Complete 2 questionnaires (one will be given before the first MOM Session begins, and the other will be given after the last MOM Session)

Participants also have the choice to attend an optional Focus Group, which will be offered after the last MOM Session.

Please note, this entire Intervention will be offered online. There will be no in-person sessions or visits.

Up to half of patients affected by cancer will experience psychosocial distress. Emotional and physical symptoms are two common facets of psychosocial distress. For those managing cancer, unmet psychosocial needs can lead to lower quality of life, poorer adherence to medical treatments, and increased healthcare costs. In a recent study investigating White, African American, Hispanic, Asian and Pacific Islander patients, it was found that African American patients were significantly more likely to experience clinical levels of psychosocial distress.

Inova Life with Cancer® has developed Mind Over Matter (MOM), a group psychosocial program designed to teach emotional coping skills to anyone affected by cancer. MOM consists of five, 1.5-hour sessions. The foundational theories of MOM are Cognitive Behavioral Therapy (CBT), Acceptance \& Commitment Therapy (ACT), and the physiology of the stress response. Each session introduces a core cognitive concept and a different relaxation exercise. These sessions are structured and educational, with a focus on building skills, and are not a therapy or a support group. At the end of each session, participants are given exercises to practice the core cognitive concept and the relaxation at home. Participants are also offered optional reading to support the core cognitive concept. Practice outside of the class is vital. Thus, it is important to allow enough time to process and review the home practice exercises each week - this is the core of the program.

A retrospective secondary data analysis of the MOM intervention found a significant decrease in anxiety, depression, physical symptom severity, and physical symptom interference from pre- to post-test.

Participants who self-identify as female or a woman are eligible for the Intervention

Mind Over Matter for Black and African American Women: A Single Arm Trial Examining Feasibility and Acceptability of a Supportive Intervention

The MOM intervention will be considered feasible if 60% of the participants registered to attend the intervention (and complete the consent process) complete 4 out of 5 sessions of the intervention

Telehealth Usability Questionnaire (TUQ) which will be used to measure the primary endpoint of acceptability, the TUQ response set ranges from 1 (disagree) to 7 (agree). Anchoring the score of 4 as neither disagree or agree and 5, 6, and 7 are some levels of agreement. The MOM intervention will be considered acceptable if the average usability score, as measured by the TUQ, are equal to or above 4.5.

Patient Health Questionnaire-8 (PHQ-8) self-report 9-item Likert scale will be used to measure Depression. The first eight items are scored from 0 (not at all) to 4 (nearly every day) with scores ranging from 0 to 32. The last item asks about how difficult the depression is in terms of daily functioning, using a scale from 0 (not at all) to 3 (extremely). The higher the score, the higher the depression. Change in Depression will be considered significant if the mean PHQ-8 scores decrease from the pre- to post-test.

The Generalized Anxiety Disorder 7 (GAD-7) will be used to measure anxiety. For the first 7 items scores range from 0 (not at all) to 3 (nearly every day) with scores ranges from 0 to 21. Item 8 asks how difficult anxiety has been in terms of daily functioning. The range of scores is 0-21, with the higher score being higher levels of anxiety being reported. Change in Anxiety will be considered significant if the mean GAD-7 scores decrease from the pre- to post-test.

The MD Anderson Symptom Inventory (MDASI) will be used to measure physical symptom severity and interference with daily living. The MDASI is made up of two subscales, the first includes 13 physical symptoms and the second includes six interference items. The physical symptom severity items are rated on an 11-point scale (0 = not present to 10 = as bad as you can imagine) and the interference items are rated on an 11-point scale (0 = did not interfere to 10 = interfered completely). For both subscales, the higher the score the worse the severity and the level of interference. Change in Symptom severity will be considered significant if the mean MDASI scores decrease from the pre- to post-test.

Cultural appropriateness of the MOM intervention will be determined by participants' self-reported accounts

linguistic appropriateness of the MOM intervention will be determined by participants' self-reported accounts

Howard University

University of Louisville

University of Houston

VCU Massey Cancer Center

Tigerlily Foundation

Inova Health Care Services

feasibility study of family interviews of those who are making decisions about treatment for newly diagnosed or relapsed CNS tumors. For patients 12 years of age and younger, caregivers only will be included in the interviews. For patients 13-17 years of age, caregivers will have the option to include the patient in the interviews. For patients 18 years of age and older, patients will have the option to include their caregivers in the interviews.

Conduct qualitative interviews with patients and families who are considering treatment options for new or recurrent CNS tumors to identify specific barriers to full participation in treatment and clinical trial enrollment (e.g., transportation, childcare, ancillary expenses). Qualitative interviews will be structured to comprehensively address potential barriers but also open-ended to give patients and families freedom to discuss a wide range of challenges.

Qualitative Interviews

Wendy Moore

Adam Green

Claire Fraley

Explore factors involved in decision making for patients with new or recurrent CNS tumors and their families surrounding treatment planning and clinical trial enrollment.

Explore factors involved in decision making for patients with new or recurrent CNS tumors and their families surrounding treatment planning and clinical trial enrollment. The team will conduct qualitative interviews with a diverse group of patients and families considering treatment for new and recurrent CNS tumors to determine challenges surrounding treatment and study enrollment that may be modifiable through community, hospital, and University of Colorado Cancer Center resources. The team will then assess the impact of these resources on decision making through follow-up interviews.

CNS Qualitative Interview

Exploring Factors in Patient and Family Consideration of Treatment for Pediatric Central Nervous System Tumors

Qualitative interviews with patients and families who are considering treatment options for new or recurrent CNS tumors to identify specific barriers to full participation in treatment and clinical trial enrollment (e.g., transportation, childcare, ancillary expenses). Qualitative interviews will be structured to comprehensively address potential barriers but also open-ended to give patients and families freedom to discuss a wide range of challenges.

Children's Hospital Colorado

University of Colorado, Denver

Symptoms and General Pathology

Neoplasm Metastasis

Neoplastic Processes

Antineoplastic Agents

All Drugs and Chemicals

Niraparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Participants will receive niraparib 1x daily for each 28 day study treatment cycle up to 2 years or until disease worsens or unacceptable side effects occur.

Priscilla Brastianos, MD

This research is being done to see how effective the drug niraparib is against cancer that has metastasized to the central nervous system (CNS).

* This research study involves the study drug niraparib.

This is a single arm open-label study designed to evaluate the efficacy and safety of niraparib in treating cancer that has metastasized to the central nervous system (CNS).

The U.S. Food and Drug Administration (FDA) has not approved niraparib for cancer metastasized to the central nervous system (CNS) but it has been approved for other uses.

Niraparib is a type of drug called a "PARP inhibitor", which blocks DNA (the genetic material of cells) damage from being repaired or may prevent damage from occurring in the first place. In cancer treatment, inhibiting PARP may help kill cancer cells by not allowing the cancer cells to repair its DNA damage or prevent DNA damage associated with your diagnosis from occurring.

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.

Participants will receive the study drug for up to 2 years or until their disease worsens, they have unacceptable side effects, or they meet one of the criteria to be removed from the study. Participants will then be followed every 4 months for up to 2 years.

It is expected that about 20 people will take part in this research study.

GlaxoSmithKline, a pharmaceutical company, is supporting this research study by providing funding for the study, including the study drug.

Niraparib in Tumors Metastatic to the CNS

Genomically Guided Phase II Study to Evaluate the Clinical Benefit of Niraparib in Tumors Metastatic to the CNS

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Assessed by RANO criteria for brain metastases

Assessed by RECIST and duration of response

Assessed by cumulative incidence function (CIF), which estimates the marginal probability of each competing event via cause-specific hazards

The number and proportion of adverse events, graded as defined by CTCAE version 5.0 will be will be summarized according to system organ class and/or preferred term, severity (based on CTCAE grade), type of adverse event, and relation to study treatment.

GlaxoSmithKline

Massachusetts General Hospital

Principal Investigator

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Gland and Hormone Related Diseases

Heart and Blood Diseases

Immune System Diseases

Diseases and Abnormalities at or Before Birth

Nutritional and Metabolic Diseases

Musculoskeletal Diseases

Syndrome

Nasopharyngeal Carcinoma

Leukemia

Cholangiocarcinoma

Pancreatic Neoplasms

Skin Neoplasms

Prostatic Neoplasms

Thyroid Neoplasms

Thyroid Diseases

Stomach Neoplasms

Sarcoma

Carcinoma, Renal Cell

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Multiple Myeloma

Neoplasms, Plasma Cell

Adenomatous Polyposis Coli

Urinary Bladder Neoplasms

Vaginal Neoplasms

Gastrointestinal Stromal Tumors

Liver Neoplasms

Neuroendocrine Tumors

Thyroid Nodule

Mesothelioma

Mesothelioma, Malignant

Duodenal Neoplasms

Mouth Neoplasms

Thymoma

Thymus Neoplasms

Testicular Neoplasms

Kidney Neoplasms

Anus Neoplasms

Endometrial Neoplasms

Salivary Gland Neoplasms

Gallbladder Neoplasms

Oropharyngeal Neoplasms

Bile Duct Neoplasms

Nasopharyngeal Neoplasms

Carcinoma

Urethral Neoplasms

Laryngeal Neoplasms

Colorectal Neoplasms

Colorectal Neoplasms, Hereditary Nonpolyposis

Hypopharyngeal Neoplasms

Intestinal Neoplasms

Penile Neoplasms

Ureteral Neoplasms

Peritoneal Neoplasms

Neoplasms, Unknown Primary

Paranasal Sinus Neoplasms

Lip Neoplasms

Paraproteinemias

Genital Neoplasms, Male

Genital Diseases

Genital Diseases, Male

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Blood Protein Disorders

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Genital Diseases, Female

Genital Neoplasms, Female

Gonadal Disorders

Neoplasms, Connective and Soft Tissue

Rectal Neoplasms

Intestinal Diseases

Rectal Diseases

Urologic Neoplasms

Urologic Diseases

Colonic Diseases

Esophageal Diseases

Ken Cowan, MD

Michelle M Desler, MS

Jeannie Robbins

Noelle Beauchemin, MD

Sandy Allten, RN

Erik Harris, MD

Sandra Allten, RN,OCN,CCRP

Kellie Hyde

Luke Hazen

Joseph Meschi, MD

Amanda Baker, CCRP

Joseph T Meschi, MD

Neil Sharma, MD

Breck Hunnicutt, RN BSN CCRC

Betsy Glowinski

Anuj Agarwala, MD

Michael Zlomke, MD

Tammy Johnson, CBPN

Karrie Cheeseman, BSN, RN

Mukund Nadipuram, MD

Kelley Aldrich

Addison Tolentino, MD

Judy Bosley

Qiwei Gai, MD

Johanna DiMento, MD

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Mind Over Matter for Black and African American Women: A Single Arm Trial Examining Feasibility and Acceptability of a Supportive Intervention	NCT06168825	Cancer Breast Cancer Brain Cancer Central Nervous... Colorectal Canc... Esophageal Canc... Gynecologic Can... Head and Neck C... Gastrointestina... Genitourinary C... Melanoma Blood Cancer Lung Cancer Acceptance and ... Mind-Body Thera... Psychosocial In...	Mind Over Matte...	18 Years -	Inova Health Care Services
CNS Qualitative Interview	NCT05219149	Central Nervous...	Qualitative Int...	-	University of Colorado, Denver
Niraparib in Tumors Metastatic to the CNS	NCT04992013	Metastatic Canc... Central Nervous...	Niraparib	18 Years -	Massachusetts General Hospital
Mind Over Matter for Black and African American Women: A Single Arm Trial Examining Feasibility and Acceptability of a Supportive Intervention	NCT06168825	Cancer Breast Cancer Brain Cancer Central Nervous... Colorectal Canc... Esophageal Canc... Gynecologic Can... Head and Neck C... Gastrointestina... Genitourinary C... Melanoma Blood Cancer Lung Cancer Acceptance and ... Mind-Body Thera... Psychosocial In...	Mind Over Matte...	18 Years -	Inova Health Care Services
CNS Qualitative Interview	NCT05219149	Central Nervous...	Qualitative Int...	-	University of Colorado, Denver
Integrated Cancer Repository for Cancer Research	NCT02012699	Pancreatic Canc... Thyroid Cancer Lung Cancer Esophageal Canc... Thymus Cancer Colon Cancer Rectal Cancer Gastrointestina... Anal Cancer Bile Duct Cance... Duodenal Cancer Gallbladder Can... Gastric Cancer Liver Cancer Small Intestine... Peritoneal Surf... Familial Adenom... Lynch Syndrome Bladder Cancer Kidney Cancer Penile Cancer Prostate Cancer Testicular Canc... Ureter Cancer Urethral Cancer Hypopharyngeal ... Laryngeal Cance... Lip Cancer Oral Cavity Can... Nasopharyngeal ... Oropharyngeal C... Paranasal Sinus... Nasal Cavity Ca... Salivary Gland ... Skin Cancer Central Nervous... Central Nervous... Mesothelioma Breast Cancer Leukemia Melanoma Sarcoma Unknown Primary... Multiple Myelom... Ovarian Cancer Endometrial Can... Vaginal Cancer Neuroendocrine ... Plasma Cell Dys... Healthy Control		19 Years - 110 Years	University of Nebraska

Spots Global Cancer Trial Database for central nervous system cancer