Category: Symptom Management & Cancer Control
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Longitudinal Observational Trial to Uncover Subtypes of Cancer Cachexia (URCC-22063)
Overview This study evaluates cancer-related weight and muscle mass loss, symptoms, and physical function (cachexia) in patients undergoing treatment for colorectal, lung, or pancreatic cancer that cannot be removed by surgery (unresectable). Patients with these cancer types are at risk for developing cancer cachexia (CC), which is defined as weight loss, muscle loss, and fat…
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Comparing Telephone Symptom Monitoring Interventions for Managing Symptoms and Psychological Distress During Oral Anti-Cancer Treatment (NRG-CC012CD)
Overview In this clinical trial, symptom monitoring (interactive voice response [IVR] is compared to automated telephone symptom management [ATSM] and telephone interpersonal counseling [TIPC]) for reducing symptom burden and psychological distress (depressive and anxiety symptoms) among people receiving oral anti-cancer treatment. Symptoms are the number one driver of treatment interruptions and unscheduled health services use.…
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Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25 (NRG-BR009)
Overview This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25…
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Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors: A Multi-Center Randomized Double-Blinded Controlled Trial (NRG-CC011)
Overview The goal of this trial is to determine the efficacy of advanced cognitive training for cancer survivors suffering from cancer- and cancer-treatment-related cognitive dysfunction. For millions of cancer survivors, cognitive dysfunction is a prevalent, severe, and persistent problem that has long been associated with poor work-related and health-related outcomes. Evidence suggests that a significant…
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Optimizing Psychosocial Intervention for Breast Cancer-Related Sexual Morbidity:The Sexual Health and Intimacy Education (SHINE) Trial (WF-2202)
Overview The goal of this clinical trial is to develop an effective internet-delivered program to help breast cancer survivors manage cancer-related sexual concerns. This study is being done to find out if the study approach is better or worse than the usual approach to helping breast cancer survivors manage cancer-related sexual concerns. The usual approach…
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High-dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients (URCC-22053)
Overview This phase III trial tests whether high-dose vitamin D works in treating androgen-deprivation therapy (ADT)-induced bone loss in patients with prostate cancer who are undergoing androgen-deprivation therapy. Vitamins are substances that the body needs to grow and develop normally. Vitamin D helps the body absorb calcium. Calcium is one of the main building blocks…
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Ice Compress: Randomized Trial of Limb Cryocompression Versus Continuous Compression Versus Low Cyclic Compression for the Prevention of Taxane-Induced Peripheral Neuropathy (S2205)
Overview This phase III trial compares the effect of 3 study approaches in preventing chemotherapy-induced peripheral neuropathy: 1) cryocompression, 2) continuous compression, and 3) low cyclic compression. Taxane chemotherapy drugs, such as paclitaxel or docetaxel, can cause a nerve disorder called peripheral neuropathy, which can cause numbness, tingling, or pain in the arms and legs.…
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Social Genomic Mechanisms of Health Disparities Among Adolescent and Young Adult (AYA) Survivors of Hodgkin and Non-Hodgkin Lymphoma (EAQ211)
Overview This study examines the impact of social and genetic factors on outcomes in adolescent and young adult (AYA) cancer survivors of Hodgkin or non-Hodgkin lymphoma. Compared to both older adult and childhood cancer patients, AYAs with cancer experience different diagnoses and specific biological, clinical, psychological and social factors that affect their risks for post-treatment…
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Hypofractionated Radiotherapy vs Single Fraction Radiosurgery for Brain Metastasis Patients on Immunotherapy (HYPOGRYPHE) (WF-2201)
Overview This study is designed to see if we can lower the chance of side effects from radiation in patients with breast, kidney, non-small cell lung cancer or melanoma that has spread to the brain and who are also being treated with immunotherapy, specifically immune checkpoint inhibitor (ICI) therapy. This study will compare the usual…
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Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events (A151804)
Overview This trial collects research data and samples from patients who experience immunotherapy side effects to store for use in future research studies. Studying research data and samples from patients who experience immunotherapy side effects may help researchers better understand how to predict, prevent, and treat these side effects. Key Inclusion Criteria For a patient…
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Does the Use of a Genomic Tumor Board Increase the Number of Patients Who Receive Genome-Informed Treatment (S2108CD)
Overview This clinical trial studies how well an educationally enhanced genomic tumor board (EGTB) intervention works to increase the number of patients with solid tumors that have come back (recurrent), do not respond to treatment (refractory), have spread to other parts of the body (metastatic), or are newly diagnosed and spread to other parts of…
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Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps (NRG-CC005)
Overview This trial examines colorectal cancer incidence in participants with 1 to 2 non-advanced adenomas randomized to surveillance colonoscopy at 10 years compared to participants randomized to surveillance colonoscopy at 5 and 10 years. Key Inclusion Criteria For a patient to be eligible for participation in this study, all of the following criteria must apply.…
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Improving Adolescent and Young Adult Self-Reported Data in ECOG-ACRIN Trials (EAQ202)
Improving Adolescent and Young Adult Self-Reported Data in ECOG-ACRIN Trials Overview The purpose of this study is to evaluate feasibility and acceptability of completing PROs among AYAs randomized to Choice PRO vs Fixed PRO. Key Inclusion Criteria Patient must be ≥ 18 years and ≤ 39 years of age at registration. Patient must have a…
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Optimizing Endocrine Therapy Adherence Through Motivational Interviewing and Text Interventions (A191901 GETSET)
Additional Support Program Via Text Messaging and Telephone-Based Counseling for Breast Cancer Patients Receiving Hormonal Therapy Overview This phase III trial compares an additional support program (text message reminders and/or telephone-based counseling) with usual care in making sure breast cancer patients take their endocrine therapy medication as prescribed (medication adherence). Medication adherence is how well…
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National Cancer Institute “Cancer Moonshot Biobank”
Cancer Moonshot Biobank Research Protocol Overview This trial collects multiple tissue and blood samples, along with medical information, from cancer patients. The “Cancer Moonshot Biobank” is a longitudinal study. This means it collects and stores samples and information over time, throughout the course of a patient’s cancer treatment. By looking at samples and information collected…
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A Study to Compare Two Surgical Procedures in Women With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer (NRG-CC008, SOROCk)
A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-Oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers [SOROCk] Overview This trial studies how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for women with BRCA1 mutations. Bilateral salpingectomy involves the surgical…
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Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer (WF1806)
Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer: The M&M Study Overview This study will examine the association between low muscle mass (myopenia) at diagnosis and chemotherapy toxicity in older adults with newly diagnosed advanced colorectal cancer. Key Inclusion Criteria For a patient to be eligible for participation in this study,…
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Randomized Placebo Controlled Trial of Bupropion For Cancer Related Fatigue (URCC 18007)
Bupropion in Reducing Cancer Related Fatigue in Stage I-III Breast Cancer Survivors Overview This phase III trial studies how well bupropion works in reducing cancer related fatigue in stage I-III breast cancer survivors. Bupropion is a drug that is used to treat depression, as well as to help people quit smoking. Cancer and its treatment…
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All Disease Sites; Health Disparities (DCP-001)
Use of a clinical trial screening tool to address cancer health disparities in the NCI Community Oncology Research Program (NCORP) Overview A clinical trial screening tool protocol has been developed to facilitate the formulation of research questions; particularly those evaluating factors related to populations that are underrepresented in clinical trials, and address cancer care disparities.…
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Netupitant/Palonosetron Hydrochloride and Dexamethasone With or Without Prochlorperazine or Olanzapine in Improving Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer (URCC 16070)
Treatment of Refractory Nausea Overview This randomized phase III trial studies how well netupitant/palonosetron hydrochloride and dexamethasone with prochlorperazine or olanzapine work compared to netupitant/palonosetron hydrochloride and dexamethasone in improving chemotherapy-induced nausea and vomiting in patients with breast cancer. Antiemetic drugs, such as prochlorperazine and olanzapine, may help lessen nausea and vomiting in patients with…
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The National Myelodysplastic Syndromes (MDS) Study (NHLBI-MDS)
The National Myelodysplastic Syndromes Natural History Study Overview Multi-center study enrolling patients suspected or newly diagnosed with myelodysplastic syndromes (MDS), myelodysplastic syndromes/myeloproliferative neoplasms (MDS/MPN) overlap disorder, or idiopathic cytopenia of undetermined significance (ICUS). Participants will be followed long term. Clinical data, blood, and tissue samples will be collected to establish a biorepository to facilitate the…
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Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer (EA1151)
Tomosynthesis Mammographic Imaging Screening Trial (TMIST) Overview This randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment. Key Inclusion…