Cancer Control
Description – 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.
Patients undergo collection of tissue and blood samples (and optional stool samples from patients experiencing colitis) at the time of registration (within 72 hours of confirmation of one or more severe irAEs) and at 1 month after registration. Patients' medical records are also reviewed for up to 1 year.
Description – 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 patients take the medication as prescribed by their doctors, and good medical adherence is when patients take medications correctly. Poor medication adherence has been shown to be a serious barrier to effective treatment for hormone receptor positive breast cancer patients. Adding text message reminders and/or telephone-based counseling to usual care may increase the number of days that patients take their endocrine therapy medication as prescribed.
Clinicaltrials.gov/study/NCT04379570
Alliance-a191901 - Optimizing Endocrine Therapy Through Motivational Interviewing and Text Interventions
Description – To determine whether an Internet-based pain coping skills program plus enhanced usual care, compared to enhanced usual care alone, yields significant improvements in the co-primary outcomes of pain severity (as measured by the Brief Pain Inventory (BPI)) and pain interference (also measured by the BPI) from baseline to the post-intervention assessment for cancer survivors with persistent pain.
This is a parallel group randomized controlled, prospective study that examines the effect of an Internet-based pain coping skills program on pain severity and pain interference among adult cancer survivors experiencing persistent cancer-related pain. The study also explores the effects of an Internet-based pain coping skills program on opioid/analgesic medication use, health-related quality of life, pain management self-efficacy and various other factors relevant among populations with persistent pain (i.e., fatigue, sleep, emotional distress, positive affect, pain impact, perceived cognitive problems, and cognitive performance), as well as qualitative assessments of participants experiences with pain and the intervention. A total of 250 participants will be enrolled (125 per arm) and randomized into the internet program arm (plus enhanced usual care) or Enhanced Usual Care alone.
Each participant will be enrolled in the study for 9 months (from randomization at week 0 to the final follow-up assessment at week 34).
Clinicaltrials.gov/study/NCT04462302
WF-1901 - Internet-delivered Management of Pain Among Cancer Treatment Survivors (IMPACTS)
Description - This phase II trial studies how well green tea catechins work in preventing progression of prostate cancer from a low risk stage to higher risk stages in men who are on active surveillance. Green tea catechins may stabilize prostate cancer and lower the chance of prostate growing.
ECOG-EA8184 - A Phase II Randomized Double Blinded Study of Green Tea Catechins (GTC) vs. Placebo in Men on Active Surveillance for Prostate Cancer: Modulation of Biological and Clinical Intermediate Biomarkers
Description – This phase III trial compares the effects of olanzapine versus megestrol acetate in treating loss of appetite in patients with cancer that has spread to other places in the body (advanced). Olanzapine may stimulate and increase appetite. This study aims to find out if olanzapine is better than the usual approach (megestrol acetate) for stimulating appetite and preventing weight loss.
Description – 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.
This is a prospective cohort study that examines the impact of myopenia on chemotherapy toxicity in overall survival (OS) in older adults with newly diagnosed metastatic colorectal cancer (CRC) receiving 5-Fluouracil (5FU)systemic chemotherapy. The study also explores the mediating influence of genetic variation in the association between myopenia and chemotherapy toxicity.
Clinicaltrials.gov/study/NCT03998202
URCC-18007 - Randomized Placebo Controlled Trial of Bupropion For Cancer Related Fatigue
Description – This phase III trial studies how well bupropion works in reducing cancer related fatigue in cancer survivors. Bupropion is a drug that is used to treat depression, as well as to help people quit smoking. Cancer and its treatment can cause fatigue. Giving bupropion may improve cancer related fatigue in cancer survivors.
URCC-21038 - Disparities in REsults of Immune Checkpoint Inhibitor Treatment (DiRECT): A Prospective Cohort Study of Cancer Survivors Treated with anti-PD-1/anti-PD-L1 Immunotherapy in a Community Oncology Setting
Description – This study compares treatment outcomes between patients of African American/Black (AA) ancestry and European American/White (EA) ancestry currently receiving immune checkpoint inhibitor treatment. Collecting samples of blood, saliva, stool, and health and treatment information from racially diverse patients receiving immune checkpoint inhibitor treatment over time may help doctors better understand healthcare disparities among all cancer patients.
WF-2303cd - Understanding and Enhancing Health-related Social Needs (HRSN) Screening Among Community Oncology Practices
Description – This study evaluates health related social needs screening processes in community oncology clinics.
The primary objective of this study is to assess current processes around health related social needs (HRSN) screening among NCORP clinics and categorize clinics based on their implementation of HRSN screening. The primary endpoint will be a detailed understanding of current processes, with attention to variability by key clinic characteristics.
There are 3 parts of the study in which participants can participate in one or all parts (3 total).
Part 1: Participants attend training, complete clinic assessments and observations and may complete an interview on study.
Part 2: Identified clinic staff will be interviewed to discuss factors that influence HRSN screening at their clinic and help develop generalized guidance.
Part 3: Participants attend a co-design workshop and complete surveys on study feasibility.
ECOG-EAY191-e5 - A Randomized Phase II Study of AMG 510 (Sotorasib) with or Without Panitumumab in Advanced Solid Tumors: A ComboMATCH Treatment Trial
Description – This phase II ComboMATCH treatment trial tests how well AMG 510 (sotorasib) with or without panitumumab works in treating patients with KRAS G12C mutant solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Sotorasib is in a class of medications called KRAS inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells. Panitumumab is in a class of medications called monoclonal antibodies. It works by slowing or stopping the growth of cancer cells. Giving combination panitumumab and sotorasib may kill more tumor cells in patients with advanced solid tumors with KRAS G12C mutation.
DCP-001 - Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)
Description – An important aspect of conducting clinical research is to enhance enrollment so that trial accrual more accurately reflects the broader population that will/may ultimately benefit from the trial results and to collect information from patients that will inform future research questions and better trial development/structure. Implementation of a patient clinical trials screening tool within NCORP will provide data to enhance patient enrollment to clinical trials, including minority and underrepresented populations. The NCORP Clinical Trials Screening Tool will also provide a unique opportunity to collect expanded demographic and clinical data to increase our understanding of who is or is not enrolled in NCI sponsored trials and address research questions related to disparities in cancer care and cancer care delivery. The NCORP Clinical Trials Screening Tool will add eight elements that are not currently being collected including marital status, rural status, education level, employment status, annual income, insurance status at time of clinical trial screening, method of diagnosis and comorbidities.
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