159 Clinical Trials for Various Conditions
Cancer remains a vital public health concern in the U.S. Research evidence has shown that physical activity provides many physical and mental health benefits after cancer diagnosis and plays an important role in reducing all-cause, cancer-related death and cancer events in the elderly cancer survivors (CS). Adopting a physically active lifestyle may decrease cancer risks, improve cancer prognosis and quality of life. However, most CS did not achieve recommended 150 min/week of moderate-to- vigorous physical activity (PA \[MVPA\]). This issue is particularly pronounced for CS in low-income areas who tend to have considerably less access to PA-conducive environments compared to urban peers. To this accord, it is imperative to promote PA in elderly CS to offer appropriate supportive care. Thus, implementing innovative PA interventions with the goal of improving their self-regulatory health behaviors in CS is paramount.
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.
The purpose of this research study is to develop a geriatric oncology collaborative care intervention to enhance the quality of life, symptom burden, and functional outcomes of older adults with advanced gastrointestinal (GI) and genitourinary (GU) cancers.
Multicenter, international, prospective, observational study, designed to evaluate the postoperative results in terms of quality of life and functional recovery of elderly patients after major cancer surgery. The global expected duration of the study is 3 years, during which cancer patients over 70 years old undergoing major surgery will be evaluated before and after the surgical intervention, at 30 days, 3- and 6-months follow-up. The study is non-for-profit. Given the observational nature of the study, the original treatment plan, as designed by each individual recruiting centre, will not be altered or affected by the study inclusion. Inclusion in the study does not imply any deviation from the current standard of practice, and no change is expected to the perioperative treatment at any point. Patients will be only asked to complete simple screening/assessment tests.
The objective of this study is to implement a brief geriatric oncology assessment (GOA) in a community-based oncology clinic, the Scotland Cancer Treatment Center - a clinic within the Duke Cancer Network, located in the rural, low resource Scotland County community of North Carolina. Secondly, the investigators will evaluate the effectiveness of the brief GOA by comparing historical and post-GOA service referral patterns and adherence to planned cancer therapy. For this study, the investigators will prospectively enroll up to 60 patients who have been diagnosed and/or treated for cancer to complete the brief GOA. In addition to these 60 patients, the investigators will also conduct retrospective chart reviews on 120 patients that would be eligible for this study to evaluate past referral patterns. Eligible and consented patients will complete the brief GOA at the Scotland Cancer Treatment Center alongside their normal clinic appointment. The investigators will assess impact on the healthcare system by evaluating referral patterns (i.e., how many, what type of services) using the brief GOA data and EHR data. The study value includes the possibility for recognition and access to additional health care referrals if needed.
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.
The goal of this study is to learn more about how we measure depression in elderly cancer patients (patients aged 70 and older). Depression is one of the most common causes of emotional distress in the elderly and continues to be under-recognized. This is a problem because depression can have a negative impact on quality of life. The symptoms of depression are linked to poor health outcomes and higher costs of health care. In fact, depression is one of the top five concerns facing the elderly today.
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).
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 is a multicenter randomized controlled trial that assesses the efficacy of a decisional intervention \[University of Rochester-Geriatric Oncology assessment for Acute myeloid Leukemia (UR-GOAL)\] compared to an attention control.
The goal of this research study is to examine adherence to national guidelines for cervical cancer screening in women age \>65. Patient surveys will provide information about women age \>65 current cervical screening practices and allow researchers to compare that information to national recommended guidelines regarding cervical screenings. Provider surveys will provide information from surveyed providers about screening knowledge and current provider practices for women patients \> 65 for cervical cancer. The results may be used to make future recommendations for improving gynecological care and to help develop effective strategies for ensuring guideline adherence.
The purpose of this study is to see if a social network support program (SOcial Networks to Activate Trust \& Adherence or SONATA) is helpful for older individuals receiving cancer treatment. The SONATA program will last for about 4 months. There are a total of 6 coaching sessions. The first 5 sessions will be held approximately every 1 to 2 weeks. Session 6 or the final session will be held approximately 1 to 2 months after session 5. Each session will last for about 1 to 2 hours.
Pilot study assessing the feasibility and acceptability of the ABC123 framework, as well as goal concordance between patient and clinician stated goals. Patients \>60 years old with recently diagnosed advanced, incurable cancer in for a first consultation at a participating medical oncology clinic. The team will pilot test the ABC123 framework delivery by an advanced practice provider working with a medical oncologist to inform the overall care planning process. This framework will routinely incorporate and implement existing resources from these 3 transdisciplinary tenets (geriatric, oncology, and palliative medicine) into initial care planning in a patient-centered manner. The team will follow patients from initial care planning to 6 months post-intervention and assess additional stakeholder feedback on barriers and facilitators to implementation.
The objective of the study is to evaluate the feasibility of a combined mobile health exercise and cognitive rehabilitation intervention and its effect on cognition in a single-arm pilot study that recruits cancer survivors.
This is a minimal risk, pilot cluster randomized controlled trial (CRT) to determine the feasibility and acceptability of training medical oncologists to use the Best Case/Worst Case-Geriatric Oncology (BC/WC-GeriOnc) communication tool in clinical practice with older adults with cancer.
The purpose of this study is to find out if a telemedicine program for older adults in cancer treatment is a practical way to understand and meet these participants' unique needs. Telemedicine is the use of secure video technology on a desktop computer, laptop, smartphone, or tablet to provide and receive healthcare from a distance. The telemedicine program used in this study is called a tele-geriatric oncology program. It involves the participant and a study nurse meeting by videoconferencing during 2-6 telemedicine visits. As part of the program, the participant and the study nurse will discuss the participant's symptoms and aging-related needs.
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 will examine the association between low muscle mass (myopenia) at diagnosis and chemotherapy toxicity in older adults with newly diagnosed advanced colorectal 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.
The investigators hypothesize that frailty assessment prior to concurrent chemotherapy and radiation therapy in the elderly will predict treatment-related toxicity and morbidity and that such assessment at serial time points will help improve treatment and outcomes for these patients.
The study will look at conducting a medium-intense walking program called Walk With Ease with cancer patients age 60 and above who are starting chemotherapy treatment. We will measure how many of these patients complete their participation in this program.
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.
Persons over age 65 years constitute a large and growing population of cancer survivors. Available data indicate that both short- and long-term female breast cancer survivors report more limitations related to strength and mobility than women with cancers of other sites and women without a personal history of cancer. Further, better mental health among breast cancer survivors has been shown to protect against physical decline and overall quality of life. The combination of mental and physical interventions may result in substantial improvements in quality of life. Tai Chi Chih (TCC), a form of mind-body exercise, is one such intervention. TCC may be particularly suited toward elderly breast cancer survivors with impaired physical and/or mental functioning, yet despite its increasing popularity and benefits in healthy and diseased populations, its benefits have never been scientifically evaluated in this population. The overarching goal of this study is to conduct preparatory work regarding the effects of TCC on quality of life and physical function that will underpin future definitive trials of TCC in elderly cancer survivors. As part of this 12-week trial, participants will be randomized to a TCC or a health education control group (HEC). Establishment of meaningful interventions that facilitate a more positive cancer survival experience in old age is an important issue; there are substantial public health and clinical benefits should a TC intervention be successful in this patient population.
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.
This study is focused on understanding how the investigators can improve upon breast cancer and health outcomes for older participants with breast cancer.
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.
Study comparing two regimens of nab-paclitaxel and carboplatin combination in elderly subjects (≥ 70 years old) with advanced NSCLC