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NCT ID: NCT05667571 Completed - Cancer Clinical Trials

Symptom Communication in Advanced Cancer

Start date: January 9, 2019
Phase:
Study type: Observational

Background Improving patient-provider communication is a fundamental and cost-effective method to advance patient outcomes, including symptom management which is often the primary goal of care for patients with advanced cancer. Unfortunately, some studies revealed the poor quality of symptom communication among cancer patients and healthcare providers. While these evidences suggest important gaps in communication about symptoms with some of the most vulnerable patients, little is known about the patterns and associating factors of symptom communication. Purpose and Specific Aims The proposed 3-year pilot project aims to provide an enrich and systematic description of symptom communication by validating a newly developed typology of interaction patterns of symptom communication (TIPSC) between patients with advanced cancer, their caregivers, and healthcare providers and explore factors related to each interaction pattern. The specific aims are to: (1) validate TIPSC in Taiwanese advanced cancer population, (2) explore patients' /caregivers' experience and thoughts of symptom discussion in regard to their interaction patterns and symptom management, and (3) examine relationships between interaction patterns and (a) demographic factors, (b) symptom severity, (c) congruence in symptom assessment between patients/caregivers and providers, (d) patients'/caregivers' perceived ability to communicate with providers, and (e) patient/caregiver satisfaction. Sampling This pilot study plans to recruit about 50 patient/caregiver - oncologist dyads. The recruitment process contains three stages. First, medical oncologists who are currently in clinical practice at participating institutions and care for patients with solid tumors will be approached. Second, participating oncologists' patients will be recruited if they are: (1) currently a patient of a participating oncologist, (2) diagnosed with stage III or IV solid cancer, (3) aged 20 years or older, (4) able to tolerate an interview that will last approximately 30 minus, and (5) able to speak Chinese or Taiwanese. Finally, if applicable, adult caregivers who intent to join selected out-patient-department (OPD) visit with the patients will also be recruited. Research Design This is a mixed-methods study with a two-phase exploratory sequential design. The first phase is a qualitative descriptive study in which the investigators will record patient/caregiver-oncologist OPD visits and conduct patient/caregiver interviews to address aim 1 and 2. Discourse and conversation analysis will be used to analyze the recorded visits and content analysis will be used to analyze the interviews. The second phase is a correlational study in which the investigators use questionnaires to measure variables and examine their relationship with interaction patterns (aim 3). Descriptive statistics, binomial logistic regression, and linear regression will be used to analyze quantitative data. Expecting Results This is a pioneering study addressing the patterns and associating factors of symptom communication in Taiwanese patients with advanced cancer. The findings will systematically map out the patient/caregiver-provider symptom communication and identify relationships between communication patterns and meaningful indicators. This proposed study is a critical step to understand patient/caregiver-provider communication regarding symptoms in order to pinpoint symptom management and communication barriers and design proper interventions in Taiwan.

NCT ID: NCT05629507 Completed - Pain Clinical Trials

Effectiveness of Immersive Virtual Reality in Patients With Cancer

Start date: July 1, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to study the effects of Immersive Virtual Reality in patients with cancer undergoing chemotherapy. The main questions it aims to answer are: - Could the immersive virtual reality application prevents or reduces anxiety, prevents or reduces fatigue, prevents or reduces pain, improves therapeutic adherence, prevents or reduces adverse events, then cancer patients treated with narrative medicine, and then cancer patients in standard care only? - Could the immersive virtual reality application show symptoms of cybersickness? Participants will be randomly allocated with balanced allocation ratio 1: 1: 1 into three groups: 1) Virtual Reality group; 2) Narrative medicine group; 3) Standard care group. In the virtual reality arm, patients will use a Virtual Reality headset. The multimedia contents in VR, will have a video quality from 4K to 8K, 360 degrees, and High Definition audio stereo. In control arm, patients will be free to choose different activities during the infusion of chemotherapy, such as conversation with nurses, doctors, trainees, reading, writing, watching television, listening to music or videos on their smartphone. In narrative medicine arm, patients will express their subjective experience regarding to the chemotherapy through writing. The experience will be written in free form by the patient and will cover both the cognitive, emotional and perceptual aspects. A nurse will always be available to guide the patient in the activity of expressing cognitive, emotional and perceptual contents. Researchers will compare the Virtual Reality group, Narrative Medicine group, Standard care group, to see the effects regarding to anxiety, fatigue, pain, improves therapeutic adherence and adverse events.

NCT ID: NCT05613699 Completed - Cancer Clinical Trials

Exercise for Young Adults With Cancer

YOUEX
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

Over the past decade, importance of supportive care in cancer treatment of young cancer patients has increased. However, most common cancer-related side effects, such as physical deconditioning, psychological problems, infertility, and cancer-related fatigue, are particularly problematic for young adults (AYA). Short- and long-term side effects result in impaired quality of life, social life, and physical activity levels. While there is growing evidence that physical exercise is effective in reducing disease- or treatment-related side effects, programs are generally not tailored to the unique needs of young adults. In addition, social media or web-based programs are rarely structurally integrated into existing care programs. The objective of the Your Exercise Program (YOUEX) study is therefore to address these specific needs and to improve physical exercise services for young people in Germany. To this end, this pilot study presents three approaches to physical activity enhancement, with a particular focus on web-based and cross-regional programs. All three approaches will be evaluated for their feasibility and effectiveness on fatigue, distress, quality of life, and activity levels, as well as sustained effects over 24 weeks. The YOUEX study is an exploratory intervention study in the form of a 12-week exercise program for patients aged 18 to 39 years who currently have or have had a cancer diagnosis within the past 5 years. Eligible patients can choose from three support programs: Social Media Exercise Program, Online Exercise Platform, Supervised Exercise Program. The goal is to recruit 70 to 80 patients over an 8-month period. Evaluation questionnaires will be sent at three time points (T0: start of exercise program, T1: after 6 weeks; T2: after 12 weeks; T3: after 24 weeks) with a short weekly questionnaire between T0 and T2 to assess weekly adherence and changes in fatigue. YOUEX study will collect detailed information on the acceptability and feasibility of different physical activity programs for young people and their lasting effects on fatigue, quality of life and physical activity. Should these be positive, the findings can directly inform health care practice, which would be highly relevant especially in light of the COVID pandemic.

NCT ID: NCT05531695 Completed - Clinical trials for Cancer of Brain and Nervous System

Exercise Study in Brain and CNS Cancer

ESIBAC
Start date: November 2016
Phase: N/A
Study type: Interventional

With a trend for increased survival in patients with Brain and Central Nervous System (CNS) cancers, emphasis is increasingly shifting to improving the quality of life of survivors. Performance status (a quantification tool used in patients with cancer to assess their quality of life and ability to carry out activities of daily living) is a key prognostic factor in Brain and CNS cancers and a good performance status is used in determining whether a patient is offered adjuvant treatment with chemotherapy and radiotherapy following primary surgical treatment. The performance status of a patient is defined by physical and cognitive functioning, and the beneficial effect of aerobic exercise in improving physical functioning (e.g., cardiorespiratory fitness) is well established. Thus, it is anticipated that implementing a supervised moderate intensity aerobic exercise training programme will improve the performance status of patients. An implication of this work is that, exercise regimens could be offered as additional treatment, alongside chemotherapy and radiotherapy, which might increase the chance of survival. The project design is a randomised controlled trial with two arms in which one group of patients will undergo an aerobic exercise program starting one week before surgery and continuing for three weeks in the post-operative period. Patients enrolled in this trial will continue with standard treatment including neuro-rehabilitation. The control group of patients will be given written instructions on performing flexibility and stretching exercises in addition to their usual care (including neuro-rehabilitation). The primary outcome is performance status as defined by measurements of physical functioning and cognitive ability (e.g., memory, attention, information processing speed). Physical functioning will be assessed by a timed walking test, hand-grip dynamometry and a maximum jump height test. Other measures of well-being will be assessed; including heath related quality of life using the European Quality of Life-5 Dimensions (EQ-5D) and Functional Assessment of Cancer Therapy- Brain (FACT-Br) questionnaires. Secondary outcome measures will be measurements of mood, fatigue and certain biochemical parameters, such as C-reactive protein (CRP), plasma viscosity (PV), full blood count (FBC), uric acid, insulin-like growth factor 1 (IGF-1), and insulin-like growth factor binding protein 3 (IGFBP-3). It is anticipated that a total of 30 patients will be recruited split between the two groups and each participant will not spend more than four weeks in taking part in the study.

NCT ID: NCT05493150 Completed - Cancer Clinical Trials

Antalgic Effects of Well-being Treatments in Cancer Care

Well Being
Start date: January 22, 2020
Phase:
Study type: Observational

observational , Monocentric, study to assess antalgic effects of well-being treatment in cancer care.

NCT ID: NCT05488184 Completed - Cancer Clinical Trials

Study to Evaluate the Organoleptic Perception of Oral Nutritional Supplements for Oncological Patients

SENSORIAL
Start date: June 26, 2019
Phase: N/A
Study type: Interventional

Nutritional therapy is key to helping cancer patients get the nutrients they need to maintain body weight, strength, tissue and organ integrity, and face likely infections. Some cancer treatments work best when the patient is well nourished and has enough calories and macronutrients from food. According to the latest consensus, the first step in nutritional intervention is nutritional recommendations or dietary advice. These recommendations must be realized if the patient is capable of ingesting at least 75% of the nutritional requirements that correspond to them and, if there is no approach to an upcoming risk therapy. As long as the oral route is not damaged, in dietary advice this should always be the first option. Increasingly, laboratories specialized in nutritional products prepare and improve the composition of supplements. They are complete, specific and perfect to meet the dietary needs of patients who require it. But, to fulfill their function, they have to be ingested by people and for that they have to have good organoleptic characteristics, a very important nuance that is sometimes not taken into account in the manufacture of these products. It is the object of Adventia Pharma, S.L. develop new Oral Nutritional Supplements specific for cancer patients and that meet optimal organoleptic characteristics. For this reason, a pilot study will be carried out that will evaluate different sensory and organoleptic aspects of the prototypes of supplements developed by the company to determine the consumer's reaction to the products developed and subsequently be able to select the one with the greatest acceptance.

NCT ID: NCT05461807 Completed - Cancer Clinical Trials

An Observational Study Called H2H-OSCAR-US to Learn More About How Well Rivaroxaban Works and How Safe it is Compared to Apixaban Under Real World Conditions in People in the US With Cancer Who Have Problems Due to Formation of Blood Clots in the Veins (Venous Thromboembolism)

H2H-OSCAR-US
Start date: July 14, 2022
Phase:
Study type: Observational

This is an observational study in which patient data from the past on venous thromboembolism (VTE) in people with cancer is studied. In observational studies, only observations are made without specified advice or interventions. People with VTE have problems due to the formation of blood clots in the veins. Blood clots can reduce the flow of blood to vital organs such as the lungs, which can lead to their damage. VTE can also be "recurrent". This means that the blood clots have returned after treatment. People who have cancer are more likely to develop VTE, recurrent clots, and bleeding on blood thinning treatments. To prevent the formation of new or recurrent clots in people with cancer, a newer type of blood thinner is available, called direct-acting oral anticoagulant (DOAC). Rivaroxaban and apixaban are the most used DOACs in the US. They work by blocking a certain step in the blood clotting process, the activation of a protein called Factor X. Previous studies show that DOACs may reduce clot risk compared to other available treatments but may potentially lead to more frequent bleeding. Studies looking at these points in direct comparison of rivaroxaban and apixaban a currently missing. Therefore, this study will collect real-world data from the US to learn how well rivaroxaban works and how safe it is compared to apixaban in people with cancer and VTE who are at low risk for bleeding. To do this, researchers will look at the proportion of patients that will develop: - recurrent blood clots in the veins after treatment - bleeding in a critical organ - bleeding that requires a hospital stay within 3 and 6 months after participants had a VTE that was treated with rivaroxaban or apixaban. De-identified data collected will cover 12 months before and at maximum 6 months after this VTE. They will come from US electronic health records and will cover the years 2012 to 2020. No visits or tests are required as part of this study.

NCT ID: NCT05459168 Completed - Cancer Clinical Trials

Development of Calm for Cancer Prototype Mobile App

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

Using the IDEAS (Integrate, Design, Assess, and Share) framework, the investigators will conduct the following aims: Specific Aim 1: Using two focus groups, the investigators will INTEGRATE formative work, the social cognitive theory, and perspectives from the experienced-user advisory committee (N=20) who will use the current Calm platform to identify design content and features for a standalone cancer-specific app prototype leveraging the commercial infrastructure of the Calm platform. The advisory committee will consist of both cancer patients/survivors (n=10; 5 of each) and health care providers (n=10). Specific Aim 2: DESIGN a meditation app prototype tailored to cancer patients/survivors unique needs including content related to cancer-related experiences, emotions, symptoms, physical and psychological needs, cancer-specific symptom self monitoring, social support and sense of belonging within the app and through Facebook. Specific Aim 3: ASSESS (i.e., beta-test) the prototype's form and function with cancer patients/survivors (N=30). The investigators will use Bowen's feasibility model to determine via surveys and interviews: (a) acceptability (satisfaction, perceived appropriateness, perceived positive/negative effects); (b) demand (use of the app, interest or intention to use); (c) practicality (how it makes them feel, ease of use); (d) adaptation (suggestions for modifications to improve performance for cancer patients/survivors); and (e) integration (how can the app be integrated into the cancer "system") Feasibility benchmarks: >80% of cancer patients/survivors will accept the prototype, demand the prototype for themselves and other cancer patients/survivors, and find it practical. Data from Aim 3 will guide refinement of the prototype to be tested in a fully powered RCT to establish long term engagement (Phase 2). This work will result in an evidence based, cancer-specific meditation app through a commercial platform that can be scaled and sold at discounted costs to clinic providers and directly to patients (SHARE; Phase 3).

NCT ID: NCT05438147 Completed - Cancer Clinical Trials

Effects of a CT-100 DiNaMo Component on Cognitive Functioning and Mood Symptoms

Start date: May 13, 2022
Phase: N/A
Study type: Interventional

CT-100 is a platform that provides an interactive, software based therapeutic component that may be used as part of a multimodal treatment in supplementary or standalone prescription or nonprescription software-based digital therapeutics (PDT/DTx), being developed by Click Therapeutics, Inc.

NCT ID: NCT05407298 Completed - Cancer Clinical Trials

The Use of Cannabidiol in Cancer Patients

CANPADIOL
Start date: November 15, 2021
Phase:
Study type: Observational

Alternative and complementary medicines (MAC) are commonly used by cancer patients to help them to face with anticancer treatment, reduce oncology symptoms and/or anticancer treatment adverse effects, detoxifying the body. In consistence with guidelines from the French Society for Oncology Pharmacy (SFPO), the pharmaceutical consultation includes a discussion and collection of herbs, botanical and other natural products consumed by cancer patients. This aim to prevent and manage herb-drug interaction as well as other drug-related problems (DRP). The recent French experimentation dedicated to cannabidiol for medical use could enhance interest of cancer patients in the field of MAC. However, cannabidiol have shown inhibitory effect on different cytochromes with a risk of HDI as other MAC. While the prevalence of MAC consumption is already known in some type of cancer, the consumption of CBD is less known and should be explored. Through this study we wish to know the prevalence of cannabidiol consumption in cancer patients and to establish a typical profile as well as to know the modalities of use. We also want to validate a questionnaire through a literacy scale.