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Quality of Life clinical trials

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NCT ID: NCT03281447 Completed - Quality of Life Clinical Trials

Nurse Navigation Versus Current Care Coordination During Colorectal Cancer Trajectories

NaviCan
Start date: February 26, 2016
Phase: N/A
Study type: Interventional

In western countries, the number of cancer survivors increases, and current cancer care seems insufficient with both patients' experiences of lack of help in transitions and up to 60 % of the patients having psychological problems after treatment. Further, Denmark shall have new hospitals, where researchers and healthcare professionals are expected to merge tasks and reach a higher patient experienced quality of care, without additional costs, so a better way to provide cancer care, which benefits the patients and supports the ideas within the new hospitals in Denmark, is needed. In a randomized controlled trial, the organizational structure of the healthcare system is challenged and the impact of a coherent nurse navigation practice compared to the currently existing department-specific care coordination is tested. The primary data are changes in patients' self-reported cancer-related self-efficacy from inclusion till one week after receipt of the information that they have reached the end of treatment, or in case of prolonged treatment, till not later than one year after inclusion. Patients can participate if they are 18 years of age or older, speak and understand Danish, and have a proven lesion suspected of cancer in the colon or rectum after colonoscopy or sigmoidoscopy at the Danish endoscopy centers at Odense University Hospital (the cities: Nyborg, Svendborg and Odense) or at Slagelse Hospital. Furthermore, participants must not be mentally retarded, they must not suffer from a constant life-threatening disease, and they must not suffer from, or be in the diagnostic phase of, dementia or severe psychiatric disease. Participants are allocated to support from nurse navigation or to current care coordination, and fill in four questionnaires during their cancer trajectory: 1) At inclusion, 2) Three days before treatment start, 3) One week after receipt of information about treatment end or not later than one year after inclusion, and 4) Six weeks after measure point 3. Data is analyzed using suitable statistical models. With positive results, participants in nurse navigation are better helped during their cancer trajectory and have a better psychological start on the rest of their lives after cancer treatment. Focus will be on colon and rectum cancer care, but the results will be transferable to similar settings. Furthermore, positive results will support changes in the onset of rehabilitation initiatives.

NCT ID: NCT03280914 Completed - Obesity Clinical Trials

Epidemiology and Intervention of Obstructive Sleep Apnea Based on Community

Start date: August 1, 2017
Phase:
Study type: Observational

This observational study in a real-world community was designed to perform epidemiological investigation and assess effect of CPAP intervention of obstructive sleep apnea.

NCT ID: NCT03277157 Completed - Quality of Life Clinical Trials

B. Lactis B94 Effects of Gastrointestinal Function

Start date: December 8, 2017
Phase: N/A
Study type: Interventional

The aim of this study is to determine the effect of daily consumption of Bifidobacterium animalis ssp lactis B94 (B. lactis B94) on stool frequency, gastrointestinal (GI) transit time, and gastrointestinal symptoms in adults with Prader-Willi syndrome. Participants (18-75 years old, n=36) will be recruited and enrolled in a 20-week randomized, placebo-controlled, crossover study. Study participants will be randomized to B. lactis B94 or placebo each for a 4-week period, preceded by a 4-week baseline and followed by 4-week washouts. Participants will complete daily questionnaires about stool frequency and stool form (transit). Dietary intake will also be assessed. A total of 5 stools (one in each period) will be collected for exploratory microbiota analysis. It is hypothesized that the B. lactis B94 will increase stool frequency, decrease the percentage of slow transit stools, and improve GI symptoms

NCT ID: NCT03277027 Completed - Quality of Life Clinical Trials

Health Related Lifestyle and Quality of Life in Children With Cerebral Palsy

Start date: May 26, 2017
Phase: N/A
Study type: Interventional

The primary aim of this study is assessing physical activity, the quality of sleep and health related quality of life in children with cerebral palsy, and parenting stress of caregivers of the children with cerebral palsy in Korea.

NCT ID: NCT03271788 Not yet recruiting - Stroke Clinical Trials

Can Stroke Patients and Their Caregiver Benefit From Additive Mindfulness Training

Start date: December 1, 2017
Phase: N/A
Study type: Interventional

The main purpose of the study is to find out if MBSR (Mindfulness) in addition to occupational therapy, can improve the therapeutic results in stroke-patients and help relatives of stroke patients to improve their quality of life.

NCT ID: NCT03266120 Completed - Healthy Clinical Trials

Health Benefits of Gardening

Start date: August 3, 2017
Phase: N/A
Study type: Interventional

The objective of the research is to test the hypothesis that participating in group-based gardening or group-based art activities may alter the mental health and cardiac physiological status of a wellness population of women ages 26-49. Assessment of the effects of gardening or art activities on the experimental population will take two approaches, the first being the use of physiological measurements of heart rate and blood pressure. The second approach will employ six widely used and well-established self-reported assessment instruments that will capture information about the health and well-being of participants. These measurements and assessments will provide a psychometrically-based before and after mental health status and between treatments health summaries of the participants in the gardening group and those engaged in the art group activities.

NCT ID: NCT03258138 Completed - Quality of Life Clinical Trials

Feasibility and Implementation of a Healthy Lifestyles Program

Start date: February 15, 2018
Phase: N/A
Study type: Interventional

Chronic conditions, such as obesity and diabetes, are increasing worldwide. Lifestyle changes (e.g., physical activity, healthy diet, sufficient sleep, managing stress, smoking cessation) are often recommended to prevent or manage these conditions, but changing habits is difficult. Mental health can play a role in the ability to seek out and follow through on the changes necessary to achieve or maintain a healthy lifestyle, yet this aspect is rarely addressed, and access to mental health services is often limited. Furthermore, individuals are influenced by factors at the individual, interpersonal, community and policy levels (e.g., lack of socialization, unsafe neighborhoods). These factors can act as barriers and need to be addressed in order for individuals to make sustainable lifestyle changes. A new year-long person-centered healthy lifestyles program is proposed to address the "how to" gap in making lifestyle changes through a combination of individual and group sessions. The feasibility and implementation of this new program will be evaluated through a pilot study looking at the full healthy lifestyles program compared to a less intensive version of the program. The study's hypothesis is that the full program will be feasible, acceptable and more effective for helping participants move across stages of change and for meeting their goals than the less intensive program.

NCT ID: NCT03257332 Withdrawn - Quality of Life Clinical Trials

Determining Early Development of Faecal Incontinence and Anorectal Muscle Function After Surgery for Rectal Cancer.

EDFI-Cohort
Start date: November 12, 2019
Phase:
Study type: Observational [Patient Registry]

Background: Patients treated for rectal cancer are in high risk of developing poor quality of life and faecal incontinence. Faecal incontinence has a negative impact on quality of life. However, there is limited knowledge on how to prevent it. Known exposures are ; age at surgery, gender, tumor height, pre-operative radiotherapy, surgical technique and temporary stoma. In order to evaluate the underlying mechanisms of faecal incontinence, it is central to evaluate the anorectal muscle function for sensory and motor impairment. Exposures representing different constructs in the biopsychosocial model are likewise likely to be associated with quality of life and faecal incontinence. These exposures include sexual dysfunction, urinary incontinence, fatique, physical inactivity and finding meaning in life. There are to our knowledge, no records on these relationships from prior to surgery to 2 years after. These biopsychosocial exposures are central to include when developing strategies that can prevent poor quality of life and faecal incontinence for patients treated for rectal cancer. Purpose: The primary purpose of the EDFI-Cohort study is to determine how several variables (surgical technique, anorectal muscle function, faecal incontinence, urinary incontinence, sexual dysfunction, fatigue, physical activity and finding meaning in life) develop over time and predicts quality of life. Secondary how it predicts LARS-score in patients with rectal cancer from prior to surgery to 2 years after primary treatment. Methods: We will include subjects diagnosed with rectal cancer and have received curative surgery (low anterior resection) with/without adjuvant (radiation/chemo) therapy. The cohort aim to recruit all eligible patients in a one year period. We estimate to recruit 70 patients. Self-reported outcomes will be collected with a series of validated questionnaires that subjects will be asked to complete 6 times during the two year study at 3, 6, 12, 26 78 and 104 weeks. Outcomes include: Quality of life using (EORTC QLQ-C30) (primary outcome), (CR29) and (FA12), bowel related quality of life (LARS-score) (secondary outcome), faecal incontinence (Vaizey score), urinary incontinence (ICIQ-UI), (MLUTS/FLUTS) and (MLUTSsex/FLUTSsex), physical activity level from Danish National Health Profile and finding meaning in life (SOME). Objective measures will be collected at 6 weeks, 6 months, 12 months and 24 months and include: Anorectal manometry that measures anorectal muscle function and rectal perception, a digital examination of anorectal muscle function using the Digital Rectal Examination Scoring System (DRESS) and the six-minute walk test a measure of submaximal exercise capacity. We plan to analyze the EDFI-Cohort study as repeated measures with both simple and multiple linear regression models for the continuous data. We plan to adjust for known confounders and variables related to treatment.

NCT ID: NCT03257007 Completed - Quality of Life Clinical Trials

Mindfulness to Enhance Quality of Life and Support Advance Care Planning

MEANING
Start date: May 9, 2017
Phase: N/A
Study type: Interventional

The MEANING trial is a randomized controlled mixed methods pilot designed to compare a novel mindfulness meditation-based intervention (MEANING) to usual care for adults with advanced-stage solid malignancies and their family caregivers.

NCT ID: NCT03256318 Terminated - Quality of Life Clinical Trials

PLAY LONG: The Effect of Sports and Recreation Participation for Young chiLdren With physicAl disabilitY

PLAY-LONG
Start date: August 30, 2017
Phase:
Study type: Observational

Ten year longitudinal survey following children with disabilities who have participated in Sports and Recreation from a young age (5 to 10), and the parents of children who have participated in Sports and Recreation at a young age (5 to 10). These children will be followed for 10 years with surveys every 6 months, whether they are currently participating in sports and recreation activities or not. The purpose of this longitudinal study is to examine the effects of early participation in organized sports and recreation activities (S&R) on self-reported health and health-related quality of life of children and youth (C&Y) with disabilities and their parent-reported social participation. This project will examine child and parent reported differences between: 1. C&Y with disabilities who participate in S&R and those who have discontinued participation in S&R programs 2. C&Y with disabilities who participate in sports vs. those who participate in recreation, and 3. C&Y with disabilities who participate in S&R and normative data on C&Y with disabilities and those without disabilities.