Clinical Research Directory

Fear of Cancer Recurrence Therapy (FORT): Turkish Cultural Adaptation and Implementation Project

This project had two phases. In the first phase, the group-based Fear of Recurrence Therapy (FORT) was culturally adapted for Turkish cancer survivors (Nüks Korkusu Terapisi, NKT) through a four-stage process based on the WHO and ecological validity frameworks: literature review, translation and expert review of the manual, cognitive interviews with survivors and psycho-oncology experts, and an adaptation workshop. In the second phase, a two-arm randomised controlled trial compared NKT with an active CBT-based supportive group in women with stage I-III breast cancer. Both interventions were delivered online in six weekly group sessions. The planned sample was 136 participants (68 per arm); 100 were randomised (50 per arm). Questionnaires were completed at baseline (T0), post-treatment (T1), and 3 (T2) and 6 (T3) months after the final session. The primary outcome was the total score of the Turkish Fear of Cancer Recurrence Inventory at 3 and 6 months; secondary outcomes were intolerance of uncertainty, self-efficacy, quality of life and cancer coping. Analyses were planned as repeated-measures ANCOVA within a general linear modelling framework.

Cities for Better Health Childhood Obesity Prevention Initiative in JAPAN

The goal of this interventional study is to prevent childhood obesity in children aged 6-12 years in Chiba City, Japan. The main questions it aims to answer are: * Does the multi-component intervention for environments around children reduce the BMI z-score of children aged 6-12 years after one and two years? * Does the multi-component intervention for environments around children improve the health-related quality of life (assessed by KIDSCREEN-10) of children aged 6-12 years after one and two years? Researchers will compare school clusters receiving the intervention to control clusters to see if the intervention package promotes healthy eating, increases physical activity, improves health-related quality of life, and reduces obesity prevalence. Participants will: * Attend elementary schools within participating clusters (either the intervention or control group). * Have baseline data collected, with follow-up assessments after one year and two years. * Potentially participate in school-based programs (nutrition education, physical activity promotion) and community-based initiatives (park activation, supermarkets) if in an intervention cluster. * Have their physical activity and dietary behavior assessed through self-report questionnaires.

Evaluating the PolarUs App in People With Bipolar Disorder

Our team recently pilot tested a new mobile app, PolarUs, co-designed with people who live with bipolar disorder (BD), to support BD self-management and quality of life (QoL) measurement. An initial study suggested the app improved QoL and mood scores over time among participants in Canada and the United States. This project aims to fully assess whether PolarUs improves QoL and mood outcomes in diverse people with BD living in Canada and the United States. To achieve this, we have (1) culturally and linguistically adapted the English version of PolarUs into French, Mandarin, and Spanish, and (2) are now conducting a randomized controlled trial (RCT) to assess whether PolarUs (in all 4 languages) improves QoL and mood outcomes in adults living with BD in Canada and the United States. Participants will: 1. Attend an eligibility assessment interview to confirm their eligibility to participate. 2. Eligible participants will be randomly assigned (like flipping a coin) to one of two groups: Group 1 - Receive access to the PolarUs app through participants' Android (Google) or iOS (Apple) mobile device for a period of 12 weeks. Group 2 - Receive access to the PolarUs app after a 12-week waiting period. During the waiting period, participants will only receive study assessments. 3. Participants will complete study assessments at the beginning and end of the 12-week period and, where appropriate, monthly during the study period. We aim to recruit approximately 480 participants from Canada and the United States to take part in the study. We would also like to understand how people with bipolar disorder use and engage with the app.

Psyllium Husk in Pediatric IBS

Children aged 6 to 17 years with IBS will be randomly assigned to either receive psyllium husk supplementation in addition to usual care or receive usual care alone. The study will compare gastrointestinal symptoms, quality of life, and gut microbiota between the two groups.

Mindfulness-Integrated Neuropsychotherapy for Traumatic Brain Injury: A Mixed-Methods Evaluation of Cognitive and Psychosocial Recovery

The goal of this clinical trial is to test the effectiveness of Integrative Mindfulness Enhanced Neuropsychotherapy (IMENP) in improving neurocognitive functioning and wellbeing among adults aged 18 to 44 years with mild to moderate Traumatic Brain Injury (TBI). The main questions it aims to answer are: * Does IMENP improve neurocognitive functioning in individuals with mild to moderate TBI? * Does IMENP improve quality of life, and reduce depression and fatigue in individuals with mild to moderate TBI? Researchers will compare participants who receive the 16 session IMENP programme to participants on a waitlist control condition to see if IMENP improves cognitive functioning and overall wellbeing. Participants in the experimental group will: Attend 16 sessions of IMENP delivered twice weekly over three months Complete mindfulness practices, cognitive rehabilitation exercises, and emotional regulation techniques during sessions Complete between session homework tasks including expressive writing, mindful activities, and reflective exercises Be assessed on neurocognitive functioning, quality of life, depression, and fatigue at baseline, post intervention, and one month follow up Participants in the waitlist control group will: Receive treatment as usual during the three month intervention period Be assessed at the same time points as the experimental group Receive three introductory IMENP sessions following study completion

Product Responsiveness to Enhanced Bioavailability Curcumin Dietary Supplements in Adults

The goal of this clinical trial is to evaluate whether distinct formulations of bioavailable curcumin supplements can improve joint comfort in adults who experience self-reported discomfort. Participants will also receive a placebo during the study, but they will not know when they receive it. The main questions it aims to answer are: * Do participants report improved joint comfort after taking each curcumin-based supplement? * Are there difference in quality-of-life scores or pain perceptions between the products? Researchers will compare the effects of the different formulations of bioavailable curcumin supplements to see if one provides greater improvements in joint comfort and related outcomes. Participants will: * Wear a fitness tracker starting at the time of electronic consent to provide continuous data on physical activity, heart rate, and sleep * Complete multiple blinded study periods involving different oral supplements, each separated by a washout period * Take one supplement twice daily during each intervention period, with intervention periods lasting between approximately two and four weeks * Complete washout periods of approximately one week between intervention periods * Complete the validated RAND-36 quality-of-life questionnaire and other study-specific questionnaires adapted from commonly used pain and global impression scales to assess joint comfort, pain perception, and overall health * Participate in a 30-day follow up period after the final supplement to complete final questionnaires and wearable data collection The study is conducted remotely using the Alethios decentralized research platform.

Impact of Pharmacotherapy Optimization in Polymedicated Lebanese Older Adults in Primary Health Care Centers

Why are the researchers doing this study? Many older adults take five or more medicines every day. Some of these medicines may no longer help them. Some may even cause harm, such as falls, confusion or tiredness. At the same time, a medicine the person needs may be missing. The researchers want to find out whether a careful review of a person's medicines helps older adults stay well. They will look at intrinsic capacity. This means the physical and mental abilities a person can draw on: memory and thinking, walking and moving, eating well, mood, eyesight and hearing. They will also look at quality of life, daily life, health and social conditions. This kind of study has not been done before in primary health care centers in Lebanon. Who can take part? You may be able to join if you: * are 65 years old or older * have been a patient at one of the health centers for at least one year * take five or more medicines for long-term health problems * can carry out your daily activities on your own What will happen in the study? About 452 people will join at the primary health care centers of the Order of Malta Lebanon. A computer will place each person in one of two groups, by chance, like the toss of a coin. About half (226 people) will be in each group: * In the first group, a pharmacist will go through all of the person's medicines. The pharmacist will use tools made for checking medicines in older people. The pharmacist will then send suggestions to the person's doctor. The doctor decides what to change. No medicine is changed without the doctor's agreement. * In the second group, people will keep taking the medicines their doctor already prescribed. These medicines are checked in the usual way, which is the same for all patients. They are not checked with tools made for older people. The study does not test any new or experimental medicine. Every month, when the person comes to pick up their medicines, the pharmacist will check the medicine list. The pharmacist will write down any change and any problem the person reports. The researchers will check the person's abilities three times: at the start, after three months, and after six months. They will also ask about quality of life, health and social conditions at the start and after six months. Each person takes part for six months. What are the possible risks and benefits? In both groups, a person's medicines may change during the study. A medicine may be added, stopped or replaced after a review. Medicines can cause new problems, such as side effects. This can happen with a new medicine. It can also happen with a medicine the person has taken for a long time. The pharmacist asks about such problems every month. Any change to a person's medicines is decided by their own doctor, as in normal care. People in the study may or may not feel better. The researchers hope the results will help care for older people in Lebanon and in other countries. What happens after the study? People in both groups keep receiving the usual care of their health center. Taking part does not change a person's right to care. Joining is a free choice. A person can stop at any time, and their care will not change.

Vomiting Prevention in Children With Cancer

The goal of this single arm trial is to learn if a machine learning (ML) model predicting the risk of vomiting within the next 96 hours will impact vomiting outcomes in inpatient cancer pediatric patients. The main questions it aims to answer are whether an ML model predicting the risk of vomiting within the next 96 hours will: Primary 1\. Reduce the proportion with any vomiting within the 96-hour window Secondary 1. Reduce the number of vomiting episodes 2. Increase the proportion receiving care pathway-consistent care 3. Impact on specific antiemetic medication administrations Exploratory: To determine whether deployment of the ML model reduces the proportion of patients with any nausea within 96 hours and to characterize references to the algorithm in clinical notes following deployment, and to determine the number of times the prediction report dashboard was opened. Newly admitted participants will have a ML model predict the risk of vomiting within the next 96 hours according to their medical admission information. The prediction will be made at 8:30 AM following admission. Pharmacists will be charged with bringing information about patients' vomiting risk to the attention of the medical team and implementing interventions.

Balance, Fall Risk, and Gait in Women With Total Knee Arthroplasty

Total knee arthroplasty (TKA) is a commonly performed surgical procedure aimed at reducing pain, restoring joint function, and improving quality of life, particularly among older women. Despite improvements in pain and functional outcomes following TKA, findings regarding balance, fall risk, and gait performance remain inconsistent. Impairments in these parameters may adversely affect daily activities, independence, and overall quality of life. Unlike previous studies that have primarily focused on one or two outcomes, this study will comprehensively evaluate balance, fall risk, gait performance, and quality of life in postmenopausal women who have undergone TKA. The findings are expected to provide a more holistic understanding of long-term functional outcomes following TKA and contribute to the planning of rehabilitation programs. Therefore, the aim of this study is to compare balance, fall risk, gait performance, and quality of life between postmenopausal women who have undergone TKA and healthy postmenopausal women.

Enhancing Wellbeing in Community Dwelling Seniors Through Structured Arts-Based Programmes in the Active Ageing Centres: A Mixed Method Study.

The aim of the study is to evaluate the effectiveness of structured arts-based programs conducted in the selected active ageing centres (AACs), enhancing the wellbeing of seniors. The primary objectives for this study are: 1. To evaluate the effectiveness of the structured art-based programme on seniors' mental wellbeing using the 14- items Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS). 2. To understand the perspectives of the seniors on the structured arts-based program and their behaviour and attitude change in further details after attending the program. The secondary objectives of the study are: To further understand the are participant satisfaction, depression and anxiety, health-related quality of life among the community dwelling seniors.

Enhancing Self-Esteem in Patients With Multiple Sclerosis: A Randomised Controlled Trial of the Lexical Association Technique

The goal of this clinical trial is to learn whether the Lexical Association Technique (LAT) can improve well-being in people recently diagnosed with multiple sclerosis (MS), either relapsing-remitting (RRMS) or secondary progressive (SPMS). The main questions it aims to answer are: * Does the LAT increase well-being more than a placebo technique ? * Does this technique help reduce psychological distress and improve quality of life ? Participants will: * Be randomly assigned to either the LAT group or the active control group * Complete short visualization exercises at home using a personal computer * Fill out questionnaires about self-esteem, stress, anxiety, depression, quality of life, and adjustment to illness * Take part in the study over several weeks, with assessments before, after, and 14 days after the intervention Researchers will compare results between the two groups (LAT group vs. Control group) to test the immediate and lasting effects of the LAT.

Arts for Wellness (AFW): Arts-Based Social Prescribing During Inpatient Rehabilitation for Older Adults in Singapore

This mixed-methods study examined whether Arts for Wellness (AFW), an artist-led arts programme introduced during inpatient rehabilitation, improves mental wellbeing among older adults in a Singapore community hospital, and explored how and for whom it works. Adults aged 50 years and above admitted to Outram Community Hospital for rehabilitation were randomly assigned (2:1) to AFW plus standard care or to standard care alone. AFW consisted of six group sessions (twice weekly for 3 weeks, 45-60 minutes each) in either dance or literary arts, delivered by trained National Arts Council artists. The art form was determined by which programme was running on the ward during the participant's admission, not by randomisation. After discharge, AFW participants were offered two virtual "Social Hour" sessions, a Take-Home Kit, and linkage to community arts programmes. The main question was whether AFW improves mental wellbeing (Warwick-Edinburgh Mental Well-being Scale, WEMWBS) 4 weeks after baseline compared with standard care. Secondary questions were whether it affects symptoms of depression and anxiety, health-related quality of life, patient satisfaction, and health-care utilisation, and whether any benefit is maintained up to 4 months later. Participants completed questionnaires at baseline, 4 weeks, 12 weeks, and about 20 weeks after baseline. A nested qualitative strand involved interviews with AFW participants and focus groups with artists, health-care professionals, and programme implementers to understand mechanisms, inclusion, and sustainability.

Study of Daily Step Count and Treatment Response in Rectal Cancer (STEP-R)

This study aims to examine the impact of daily physical activity, specifically step count, on treatment outcomes and side effects in patients with locally advanced rectal cancer receiving total neoadjuvant therapy (chemotherapy and radiotherapy before surgery). Using Huawei Watch Fit 2 smartwatches, we will track participants' daily step counts, heart rate, and sleep quality. The primary hypothesis is that higher step counts and physical activity levels correlate with higher rates of complete pathological response at surgery. A secondary hypothesis is that increased physical activity may be associated with fewer or less severe side effects during treatment. Participants will wear a smartwatch and complete the EORTC QLQ-C30 Quality of Life Questionnaire and the Pittsburgh Sleep Quality Index at the beginning and end of treatment. Data from the smartwatch, including step count, heart rate changes, and sleep duration, will be reviewed weekly during routine visits. Approximately 200 patients with rectal cancer will participate, and each will be followed from the start of therapy until surgery (around 4-6 months). Total data collection is expected to take 12-15 months. This study could improve cancer care by identifying links between physical activity and treatment outcomes, supporting future exercise guidelines for oncology patients.

Research on Effective Strategies After Immunotherapy for Mismatch Repair-deficient Early-stage GI Tumors

This cohort study is divided into two parts: Part A: Registry Cohort All patients with non-metastatic, MMRd/MSI-H colorectal cancers (and other gastrointestinal cancers for exploratory analysis) who have signed the general research consent will be included in a prospective registry. This includes patients who undergo primary surgical resection (+/- neoadjuvant/adjuvant therapy) or following immunotherapy, regardless of response. Part A is a multicenter observational registry with both prospective and retrospective enrolment. Prospective enrolment includes eligible patients entered into the registry after activation of the study at the respective participating site. Retrospective enrolment includes eligible patients diagnosed on or after 1 January 2024 whose clinical data were generated prior to registry activation. Both prospectively and retrospectively enrolled patients contribute to the registry analyses. Part B: Active Surveillance Cohort (Surveillance Study) A subset of patients from Part A who achieve a complete or near-complete response to ICI therapy, wish to avoid surgery, and are deemed appropriate for non-operative management by a multidisciplinary tumor board are offered inclusion in a phase II surveillance study (Part B). Patients enrolled in Part B will be analysed for the primary endpoint.

The Effect of Immersive Virtual Reality and Relaxing Videos on Lung Cancer Patients

Lung cancer is one of the types of cancer with a high incidence and mortality rate in the world and in our country. Frequently used protocols in the chemotherapy treatment of lung cancer are the Platinum-based drugs. The main side effects of this chemotherapy protocols are nausea, vomiting, neutropenia and fatigue. The side effects of cancer and chemotherapy cause patients to experience distress and their quality of life is adversely affected. Some non-pharmacological methods such as meditation, breathing exercises, and massage can be used to manage the symptoms experienced by patients due to chemotherapy for supportive care. One of these methods is virtual reality. In addition, audio-visual (video) therapy methods are other methods that can be used in the symptom management of these patients. In this study, the effect of interactive/immersive virtual reality intervention and relaxant video intervention on symptom severity, distress level and quality of life of patients diagnosed with lung cancer will be evaluated. Patients will be assigned to 3 groups: virtual reality intervention group (VR), relaxant video application group (RV) and control group (CG) by stratified randomization according to the disease stage and drug type. During the chemotherapy treatment, the patients will take interactive/immersive virtual reality (VR group) or relaxant video application (RV group) consisting of nature-themed scenarios. The interventions will be done 2 times and about 20 minutes in the first day of each chemotherapy cycle, in total 2 cycles. The control group will receive routine nursing care. Research data will be collected at different intervals during the chemotherapy course with the Patient Information Form (only once), the Edmonton Symptom Assessment Scale, the NCCN Distress Thermometer, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the Patient Follow-up Form and will be analyzed with the IBM SPSS program.

Evaluating the Role of Step Counts in Predicting Readmission and Mortality

This study investigates the relationship between physical activity, heart rate, and sleep quality with recurrent hospitalizations among discharged oncology patients. Following discharge, patients will wear Huawei smartwatches to enable daily tracking of step count, heart rate, and sleep duration through a connected smartphone app. Patients will also complete the FACT Quality of Life Survey and the Pittsburgh Sleep Quality Index during follow-up visits. The smartwatch monitoring will occur during the first 30 days post-discharge, while overall patient follow-up will extend up to 90 days. This study aims to determine if lower levels of home mobility, as indicated by step count and other activity metrics, correlate with an increased risk of hospital readmission within the 30-90 day period.

Rehabilitation Practices in Critically Ill Patients Receiving Invasive Mechanical Ventilation in the Intensive Care Unit.

This international, multicenter, observational study aims to describe rehabilitation practices in Intensive Care Units (ICUs) worldwide. The primary objective is to provide an overview of current rehabilitation strategies used in ICUs globally. Secondary objectives include assessing the relationship between rehabilitation and key ICU outcomes such as ICU and hospital mortality, length of stay, duration of invasive ventilation, extubation failures, and long-term outcomes including quality of life and functional performance 28 days post-ICU discharge. The study will also compare rehabilitation practices across different geographic and economic regions to identify potential disparities. The study is structured into three modules, with participation contingent on local resources and feasibility. The BASIC Module (mandatory for all centers) gathers fundamental data on rehabilitation practices and their association with patient outcomes. The EXTENDED Module (optional) collects more detailed information on the type, timing, duration, and safety of rehabilitation interventions, including passive exercises, active mobilization, respiratory therapies, dysphagia training, occupational therapy, and cognitive support. The EXTENDED FOLLOW-UP Module (optional) evaluates the patient's quality of life and functional recovery 28 days after ICU discharge. By examining global rehabilitation practices and their impact on patient outcomes, this study aims to improve rehabilitation strategies in ICUs, contributing to better patient care, recovery, and long-term health outcomes.

Cognitive Impact Associated With Surgery For Gastric Or Esophageal Cancer

The primary objective of this observational study is to investigate the incidence of Post Operative Delirium (POD) after gastroesophageal cancer surgery. Secondary objectives are to investigate the relationship between POD, preoperative depression, frailty, quality of life, malnutrition and sarcopenia. Participants identified with POD will be asked (at the routine follow-up meeting after surgery) to participate in an qualitative interview, in order to understand the participant's experience of postoperative delirium. The main objective aims to answer: What is the incidence of POD after gastroesophageal cancer surgery.

Impact of Mindful Self-Compassion Therapy on Self Harm Behaviors, Emotional Regulation and Quality of Life Among Patients With Borderline Personality Disorder

The primary purpose of the study is to investigate whether Mindful Self-Compassion (MSC) therapy can significantly reduce self-harm behaviors, improve emotional regulation, and enhance the quality of life in individuals diagnosed with Borderline Personality Disorder (BPD). The study aims to contribute to the existing literature by providing robust evidence on the efficacy of MSC therapy for BPD, which could inform clinical practices and improve treatment outcomes

The Effect of a Music-Assisted Mandala Intervention on Psychological Well-being and Quality of Life in Cancer Patients Undergoing Chemotherapy

Cancer is one of the most significant global health issues of our time. Chemotherapy, one of the methods used to treat cancer, not only treats the disease but also causes numerous physiological and psychological side effects that adversely affect quality of life. It has been reported that treatment adherence problems are more common in patients with a high symptom burden associated with these side effects. For this reason, it is crucial that patients have achieved psychological adaptation to their condition and treatment in order for the treatment to be effective, to ensure that toxicity is kept under control, and to ensure that the course of the disease progresses favourably. In cases of illness and failure to adhere to treatment, this can lead to unnecessary visits to the doctor, visits to A\&E, hospitalisation, and an increase in the use of healthcare services and associated costs; it may also result in the development of treatment resistance, an increased burden on patients and carers, disease progression, and even death. Various non-pharmacological approaches, such as exercise, expressing emotions and art therapy, can be used to ensure the patient's adherence to treatment. It has been reported that mandala practice, a form of art therapy, reduces anxiety, fatigue, insomnia and stress. In light of this information, the aim of this study is to assess the effect of mandala practice on psychological adjustment to the disease and treatment, and on quality of life, in cancer patients undergoing chemotherapy.

Societal Burden Associated With Type 1 Diabetes in Canada

The purpose of this observational study is to estimate the burden of T1D on caregivers of patient with T1D in terms of work productivity, healthcare resource utilization and quality of life.

Acute Metabolic Response Versus Long-term Adaptation to a Vegan Diet

At baseline, venous blood samples were collected from all eligible participants. The following biochemical parameters were analysed: serum electrolytes (mineral profile), fasting glucose, creatinine, urea nitrogen, total proteins, albumin, bilirubin, liver enzymes, C-reactive protein (CRP), total cholesterol, triacylglycerols (TAG), serum iron, active vitamin D, vitamin B12, complete blood count. At baseline, all participants also underwent standardized anthropometric measurements, including height (cm), body weight (kg) and BMI was calculated accordingly. Body composition was assessed using bioelectrical impedance analysis with the InBody Tanita MC-780MA device. The following parameters were recorded: total body fat (kg, %), visceral fat (kg, %), skeletal muscle mass (kg, %), total muscle mass (kg, %), total body water (kg, %), sarcopenic index (kg/m²), phase angle. To assess health-related quality of life and symptom burden, all participants completed validated questionnaires: World Health Organization Quality of Life - Brief Version (WHOQOL-BREF), Patient Assessment of Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM), Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-10), Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QoL) and Patient Health Questionnaire-15 (PHQ-15). After the one-month intervention, participants in the VEG group repeated laboratory testing, anthropometric assessment, body composition analysis, and questionnaire evaluation. The same follow-up assessments were performed in the WD group for comparative purposes. Long-term vegans (VEG-P) did not undergo repeated measurements. Dietary Monitoring and Adherence At study enrolment, all participants were offered a dietary consultation to improve adherence to the assigned dietary regimen. Participants were also instructed to maintain a food diary throughout the study period, which was periodically reviewed via telephone or email consultation.

Virtual Senior Center

In a 3-group trial with randomization and follow-up for 12 months, we will compare use of the VSC as well as health and quality of life outcomes among 650 older adults in St. Louis who receive either: (1) home delivered meals AND a GrandPad; (2) home-delivered meals but no GrandPad for 6 months; and (3) in person meals at senior center but no GrandPad.

Compassion Strikes Back

Research has shown that LVAD patients and their caregivers typically experience increased mental health concerns and decreased quality of life following LVAD implantation and hospital discharge. The purpose of this study is to explore how to improve quality of life for LVAD patients and their caregivers in the initial transition from hospital to home after LVAD implantation. Over the course of the study, participants will complete 2 surveys: one when participants are in the hospital and one at a 2-month post-hospital follow-up appointment with the participants' cardiologist. Participants may be contacted if there is data missing from surveys. Participants may also be provided with information on improving mental health in the form of handouts or a brief meeting with a psychology provider.