65 Clinical Trials for Various Conditions
The Cancer Health Empowerment for Living without Pain (Ca-HELP) is an evidence-based communication tool that empowers and engages patients to communicate effectively with their physicians about pain. The Ca-HELP intervention is rooted in social-cognitive theory which posits that behavior change and maintenance depends largely on individuals' ability and self-efficacy to execute a specific behavior. Ca-HELP coaches patients to ask questions, make requests, and signal distress to their physicians in order to achieve improved pain control. Previous research indicates significant improvement among cancer patients in their self-efficacy to communicate about their pain to their oncologists and reductions in pain misconceptions and pain-related impairment. Although a promising tool among geriatric cancer patients, Ca-HELP is not currently designed for optimal dissemination in rural settings.
Implementation of a home based exercise program to reduce functional decline, cancer related fatigue (CRF) and improve quality of life in the elderly gynecologic oncology patient Problem: Can prevention of CRF and loss of function improve QOL in the elderly gynecologic oncology patient undergoing chemotherapy? Support: Fatigue and its impact on QOL is a major concern with the elderly patient receiving chemotherapy. When compared to younger adults QOL is more important than gain in survival for elderly patients. (Eyigor, et al., 2010). The National Comprehensive Cancer Network recommends exercise as the most effective intervention for cancer related fatigue. Methods: This is a single institution randomized controlled study to evaluate a home based exercise program in elderly gynecologic oncology patients undergoing chemotherapy. Subjects will be randomized to the intervention group or to the control group receiving usual care. Intervention group will receive a home exercise program 3 days weekly consisting of 30mins of strength and aerobic activity, utilizing a follow along exercise DVD and patient log to assist with compliance. The two groups will be compared by 1) objective PT assessment with the Berg Balance and 6 minute walk test (before or after) Cycle 1 and 6, 2) subjective nursing assessment with the NHANES (National Health and Nutrition Examination Survey) and FACIT- F (Functional Assessment of Chronic Illness Therapy: Fatigue) prior to Cycle 1 (baseline),4 (midpoint), and following cycle 6 (completion). Conclusion: PT directed home exercise program may improve CRF, functional decline, and QOL in elderly gynecologic oncology patients undergoing chemotherapy.
The purpose of this study is to develop and pilot test a behavioral intervention for elderly adults in treatment for colon cancer, to enhance their skills for managing the challenges of completing chemotherapy regimens. The investigators will assess feasibility and acceptability of the intervention, and explore preliminary efficacy of the intervention for reducing psychological distress and improving rates of optimal chemotherapy adherence.
In this prospective quality improvement study, we will develop and evaluate the feasibility and acceptability of an online patient self-reported G8 screening tool which will allow us to efficiently identify G8 positive older cancer patients to be referred to our Senior Adult Oncology Center (SAOC) for a Comprehensive Geriatric Assessment (CGA).
Our goal is to develop a reliable, physician and patient-friendly, pre-operative Thoracic Onco-Geriatric Assessment (TOGA) to predict surgical risk in geriatric oncology patients with thoracic neoplasms of the lung, esophagus, pleura and thymus, modeled upon existing CGA tools, including the Preoperative Assessment of Cancer in the Elderly (PACE)
The primary purpose of this study is to determine whether the drug OSI-774 is less toxic and potentially as good as or better than standard chemotherapy drugs, when given to subjects with non-small cell lung cancer, who are 70 years of age or older.
The investigators proposes a prospective cohort study in patients with high risk bladder cancer who have opted for radical cystectomy. The investigators aim to correlate pre-operative measures of body composition, cognitive and functional status with impaired survival at 6 months after cystectomy. Impairment in this context will be a compilation of several specific objective measures including: 1) death from any cause, 2) major complication (Clavien score7 ≥ 3), 3) loss of independent living status, 4) performance status, and 5) global well-being. The study team believes that Impairment Free Survival is an important endpoint as it accounts for many aspects of a patient's functional status that might alter a patient's choice to proceed with radical surgery.
The purpose of this research study is to addresses the challenge of managing the unique perioperative needs of older cancer patients undergoing surgical resection.
The purpose of this study is to determine whether information regarding GA and GA-driven interventions improves outcomes in older cancer patients receiving first-line or second-line chemotherapy by comparing rates of chemotherapy toxicity, hospitalizations, dose delays and early termination of treatment in patients with and without GA-driven interventions. The investigators will identify information that will be useful based on questionnaire responses and blood tests. These results will be used to better understand which recommendations and interventions will benefit older cancer patients. It is our hope that these tools, which are well-established at identifying areas of risk, will provide meaningful opportunities for intervention to promote your safety during cancer management. The investigators will be able to use this information to teach others on how to best care for adults aged 70 and older with cancer.
The purpose of this study is to examine whether psychoeducation counseling for older cancer patients undergoing treatment is feasible and worthwhile. The investigators will test this in a group or individual phone counseling format. Many cancer patients seek counseling to help with the emotional burden of their illnesses. Counseling often helps them cope with cancer by giving them a place to express their feelings. This geriatric-specific psychoeducation is intended to help older cancer patients cope with the burden of cancer and aging. The purpose of this study is to see if this type of counseling helps reduce depressive symptoms, anxiety, perception of loneliness and isolation. In addition this counseling aims to improve coping and quality of life (QOL). Individuals who choose not to take part in the intervention study will be asked if they are willing to participate in a brief refusal sub study. The purpose of the refusal substudy is to compare levels of distress in patients that choose to participate and those that decline. This will yield valuable data that will help us distinguish between patients that decline due to lack of interest in research and those that decline due to high levels of distress. Participation in the refusal sub study consists of completion of 2 brief questionnaires.
In this randomized trial, we attempt to further define optimal palliative chemotherapy for elderly patients with advanced non-small cell lung cancer by comparing single agent treatment with weekly docetaxel versus combination therapy with weekly docetaxel plus gemcitabine.
Endometrial (uterine) cancer affects over 40,000 women each year in the United States. At this time there are no medications to prevent endometrial cancer. Women who are heavy are at increased risk of this cancer. Progestins have been used to treat endometrial hyperplasia and cancer in women who wanted to retain their fertility or who were not surgical candidates. Oral progestins are associated with side effects such as weight gain, mood changes, headaches, and acne. A device called Mirena has a type of progesterone in it. Because it is placed directly in the uterus it can give a powerful amount of progestin with less side effects. In this project, we will enroll 44 women who are aged 40-50 and who have a body mass index (BMI) greater than 40. (BMI is a measure of obesity. Normal is less than 25.) They will be randomized to either observation or treatment. The women in the treatment group will have a levonorgestrel intrauterine system (Mirena, LNG-IUS) placed for one year. All of the women will have endometrial biopsies and blood work at the beginning and end of the study. All of the women will have an ultrasound at the beginning of the study. The information will then be used to assess whether or not the LNG-IUS will be an effective prevention agent. The women will be contacted once a year for 5 years to see if they have had endometrial hyperplasia or cancer. A special lab study called microarray will be used to see what genes are turned on or off in the uterine lining.
This project assesses the feasibility and usability of the geriatric assessment platform (electronic Geriatric Assessment Platform or eGAP in 50 older patients with cancer, their caregivers, and their oncology team. Using an iterative process, we will refine the eGAP based on input from stakeholders.
This study will help determine if a short course of radiation therapy is effective to treat rectal cancer in older patients. A shorter course of radiation treatment may be better tolerated than a longer course or surgery for the treatment of rectal cancer in the elderly.
The study aims to comprehensively analyze data from a large and unselected older AML population in the US, both treated and untreated. These data will widen understanding of treatment decisions for the older Acute Myeloid Leukemia (AML) population. Through use of the SEER-Medicare Registry, the effectiveness and impact of HMA treatments as well as the effectiveness of lenalidomide will be studied.
The aim of this prospective study is to investigate quality of life and oncologic outcomes in low-risk elderly breast cancer patients randomized to adjuvant therapy with accelerated partial breast irradiation (APBI) alone or endocrine therapy alone after lumpectomy. The study population will include women age 65 years and older with low-risk tumor characteristics (tumor size \<2cm, grade 1-2, node-negative). APBI will consist of 5 fractions of radiation therapy delivered every other day to the lumpectomy cavity. Endocrine therapy will be chosen by the treating medical oncologist with an aim of 5 years duration, as tolerated by the patient. Quality of life outcomes will be measured at 1 year following lumpectomy and compared between groups. We hypothesize that the use of APBI may be superior in terms of quality of life when compared to endocrine therapy alone following lumpectomy while providing equivalent rates of disease control and overall survival. In this phase II study, we anticipate enrolling 90 women at N.C. Cancer Hospital in Chapel Hill, NC.
This study is being done to see if a new psychotherapy intervention called Cancer and Aging: Reflections for Elders (CARE) can effectively treat depression and distress in older cancer patients. CARE is a 5-session intervention that takes place over the phone. This study will compare CARE with the Social Work and Supportive Counseling (SWSC) intervention, which also takes place over the phone. SWSC is a standard psychotherapeutic intervention that has been shown to be a supportive and effective form of treatment for distress for patients with cancer. The researchers will look at which intervention is more effective in treating depression and distress in participants.
A Comprehensive Geriatric Assessment (CGA) is a set of tests used to evaluate a patient's medical, social, and functional status, and can identify impairments in these domains that may not be noticed otherwise. Prior studies have shown that a CGA can accurately predict which patients are more likely to have serious side effects from cancer treatment. However, it is unknown whether interventions can be done to address the impairments found during a CGA in order to reduce the risk of these side effects. This pilot study will test the feasibility of targeted interventions for deficits identified during a CGA in patients 65 years or older with bladder cancer that have not yet started treatment.
This study prospectively evaluates the impact of geriatric assessment reporting in real-time (GARRT) on key hospital based outcomes in a cohort of non-electively hospitalized older (\> 70 years) adults with cancer.
This research study is evaluating if co-management by a geriatrician embedded in the oncology clinic can improve outcomes for frail older adults with blood cancers. A rigorous pre-entry frailty assessment by a trained research assistant will be followed by randomization to geriatrician co-management versus usual care for patients found to be frail or pre-frail.
To look at what types of measures can be used to predict how an older person will tolerate chemoradiation treatment for head and neck cancer. This study uses surveys and a blood draw to look at the different measures.
The primary purpose of this study is to measure the association between baseline expression of the senescence effector protein p16INK4a and myelosuppression due to chemotherapy in patients with breast cancer. Patients with Stage I-IV breast cancer will be included and myelosuppression will be assessed after the first cycle of chemotherapy via measurement of an absolute neutrophil count (ANC) measured one time between days 7-11 post cycle one. Study subjects will also be asked to complete a brief health behaviors questionnaire to gather information on other relevant variables.
This study intends to explore feasibility, acceptability, and outcomes related to the use of a digital health coaching intervention for individuals who have completed primary therapy for cancer. Up to 625 individuals with diverse cancer diagnoses will be enrolled across up to 8 clinical sites to participate in a randomized wait-list control study. Those in the intervention group will receive 6 months of digital coaching up front followed by 6 months of ongoing monitoring via patient reported and clinical outcomes, as well as wearable data. Those in the control group will be monitored via patient reported and clinical outcomes as well as wearable data for the first 6 months followed by 6 months of digital health coaching. Both groups will collect fecal microbiome samples at enrollment and month 6. The study aims to explore if and how digital health coaching may be used to enhance outcomes for individuals following completion of primary cancer therapy.
This study seeks to identify if it is feasible to stop Luteinizing Hormone-Releasing Hormone (LHRH) Agonist Therapy in elderly men with prostate cancer. We hypothesize that elderly prostate cancer patients on long term androgen ablation with LHRH agonists will be permanently castrated and do not require ongoing LHRH agonist therapy. Participants will be monitored by testosterone testing throughout study.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of fluorouracil-uracil and leucovorin in treating elderly patients who have metastatic colorectal cancer.
This Interventional clinical study aims to explore how receiving information about their health and physical abilities affects the treatment decisions of older adults. The study will look at whether sharing detailed assessments of their health and functional status helps older adults better understand their condition and make informed decisions about their care. The main question it aims to answer is if providing this information changes the treatment priorities of older adults, helping them focus on what matters most to them in their medical care.
The goal of this study is to better understand how to best treat participants with advanced bladder cancer who may not be able to tolerate all of the chemotherapy drugs that have been shown to be effective. In this study, investigators are assessing the role of the survey, the Geriatric-8, and its ability to predict outcomes in older participants undergoing cancer treatments. Additionally, investigators are evaluating the differential impact of treatments on quality of life in an older and at risk population.
This randomized clinical trial studies a geriatric assessment intervention in predicting chemotherapy toxicity and vulnerabilities (or weakness) in older patients with cancer. Assessing patients' functional status, comorbidities, psychological state, social support, nutritional status, and cognitive function before treatment may help identify vulnerabilities, improve care, and decrease chemotherapy side effects in older patients with cancer.
This is a randomized controlled trial to assess the feasibility and preliminary efficacy of a multicomponent technology-supported care delivery intervention trial in 110 older patients with hematologic malignancies \[acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), multiple myeloma (MM), and diffuse large b-cell lymphoma (DLBCL)\] receiving outpatient chemotherapy on treatment-related toxicities, patient-reported outcomes, healthcare utilization, and inflammatory and epigenetic markers.
This cluster randomized clinical trial compares a geriatric assessment intervention with usual care for reducing cancer treatment toxicity in older patients with cancer that has spread to other places in the body. A geriatric assessment may identify risk factors for cancer treatment toxicity and may improve outcomes for older patients with advanced cancer.