Self-management

18

Review clinical trials related to Self-management. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
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Status: Not yet recruiting

Think-Find-Solve Activities for Insulin Self-Management in Type 1 Diabetes

Children with type 1 diabetes require lifelong insulin therapy. However, improper management of insulin therapy may lead to serious, potentially life-threatening complications. The aim of this study is to examine the effect of an activity book developed for insulin therapy on insulin self-management among children with type 1 diabetes and their parents. The study is designed as a cluster randomized controlled experimental trial at the center level, including pre-test, 1- month, and 3-month follow-up measurements. The study will be initiated after obtaining ethical approval and institutional permissions. The sample will consist of children aged 8-12 years with type 1 diabetes and their parents. The study will be conducted in two different hospitals in Istanbul; using cluster randomization, one hospital will be assigned to the intervention group and the other to the control group. Prior to the main study, a pilot study will be conducted with 15 participants in each group, and the sample size will be calculated using G\*Power based on the pilot data. Data will be collected using the "Descriptive Information Form for Children with Diabetes" and the "Insulin Treatment Self-Management Scale (ITSMS) - Child (8-18 years) and Parent Forms." The "Find-Solve-Learn Insulin Self-Management Activity Book" will be applied to the children in the intervention group. The children will be monitored to complete the activity book at least twice a month for three months, and feedback will be obtained from their families regarding the process. The data collection process will include pre-test, 1-month, and 3-month follow-up measurements. The obtained data will be analyzed using appropriate statistical methods.

Participants needed: 40
Trial details
Age: 8-12Biological sex: AllType: InterventionalSponsor: Marmara UniversityUpdated: Jun 26, 2026Locations: 1
Eligibility criteria

Not listed

Status: Not yet recruiting

Structured Nursing Intervention for Adults With Poorly Controlled Asthma: A Pilot Study

Asthma affects a large number of adults, and many of them do not achieve good control of their symptoms. Poor inhaler technique, irregular medication use, and the lack of structured nursing follow-up are among the main reasons. RESPiraIA-Asma is a 12-month structured nursing intervention designed to address these gaps in adults with poorly controlled, non-severe asthma. This is a quasi-experimental, single-group, before-and-after pilot study. Each participant is followed across six visits over one year, at baseline and at months 1, 3, 6, 9, and 12. The intervention combines therapeutic education, inhaler technique training, home peak-flow self-monitoring, biopsychosocial assessment, and a standardized nursing care plan based on internationally recognized nursing taxonomies for diagnoses, interventions, and outcomes: NANDA International (NANDA-I), Nursing Interventions Classification (NIC), and Nursing Outcomes Classification (NOC), activated by objective clinical thresholds. A central principle of the model is digital equity: the same standard of care is offered through three equivalent access routes (digital, mixed, or in-person), chosen according to each participant's digital skills, resources, and preferences, so that technology never becomes a barrier to access. The study evaluates whether the model is feasible to deliver in routine clinical practice, measured through participant retention, data completeness, and acceptability, and it looks for preliminary signals of its effect on asthma control, treatment adherence, lung function, and biopsychosocial well-being. As an exploratory pilot, it is not designed to confirm efficacy; its purpose is to inform the design of a larger future trial.

Participants needed: 30
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Hospital San Carlos, MadridUpdated: Jun 9, 2026Locations: 1
Eligibility criteria

Confirmed diagnosis of mild or moderate persistent, non-severe asthma. [+7]

Significant respiratory comorbidity (chronic obstructive pulmonary disease ( COP... [+5]

Status: Recruiting

Heart Failure Carer Support Programme: Implementation Testing in the UK.

Background: Heart failure (HF) is widespread in the United Kingdom (UK). Many of these patients rely on support from family carers who are ill-prepared and supported for this role. These carers often experience poor mental and physical health because of their caring role. HEart faiLure carer support Programme (HELP) is the first intervention in the UK developed with carers of patients with HF to support them with looking after themselves and the patients they care for. Aim: To identify the best way of delivering HELP to all carers across the UK and evaluate its impact on carers and patients. Methods: HF Nurses will deliver HELP across 3 sites in the UK to approximately 180 carers of patients with HF. The carers targeted will be those who require additional support (caring for a patient who has HF symptoms). These carers will be nominated for the project by patients identified by nurses at in- and out-patient HF appointments. These patients (around 180) will also be invited to provide information for the project. HELP includes 6 online educational support sessions (1 hour each) delivered weekly, along with an educational booklet and website that provide additional support and advice. We will evaluate the impact of HELP on outcomes for patients (i.e., hospital admissions, GP visits, and quality of life) and carers (i.e., burden, preparedness, and quality of life). Interviews and logs / questionnaires will be completed by participants and staff, which will help us understand how best to deliver HELP. Information for the project will be collected at baseline, during HELP, immediately post-HELP (6 weeks), and 6 months after finishing HELP. Impact: The findings will allow us to develop a plan for giving HELP to all carers throughout the UK to provide them with the education and support they need.

Participants needed: 360
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Queen's University, BelfastUpdated: Jun 2, 2026Locations: 5
Eligibility criteria

Aged 18 years or older [+3]

Lacking capacity to give consent [+9]

Status: Recruiting

The Development of the Walsh Asthma Self-management Programme and Feasibility of Implementation in Adults With Asthma in Primary Care

Asthma is a common medical condition in Ireland. Adult patients tend to have periods when their asthma is stable and periods when it worsens. In order to reduce these periods of worsening asthma, effective ongoing management is required day to day by adults with asthma. Teaching adults how to manage their asthma effectively, plays a huge role in improving their asthma and having a better overall quality of life. This education on managing asthma has many different parts to it. Most adults will discover they have asthma through their general practitioner (GP) and it will be continued to be checked and managed through their GP or general practice nurse (GPN) in their primary care clinic for the duration of their lives. This research study is taking place to find out if a new education programme, will help adults manage their asthma better and improve the symptoms of asthma, reducing its overall impact on day-to-day life. This study is also looking at how easy it is to introduce and for nurses to deliver this study within a GP/ primary care centre. This study is to find out if this education programme works in a real life setting and if it can lead to better control of asthma for adults.

Participants needed: 40
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Royal College of Surgeons, IrelandUpdated: May 27, 2026Locations: 1
Eligibility criteria

Adults over 18 years old

Adults under 18 years old [+4]

Status: Recruiting

Endometriosis Self-Management Strategies

The goal of this observational study is to document the lived experiences of self-managing endometriosis in people living with endometriosis who live in Europe. The main question it aims to answer is: \[How\] do support structures across personal, community, healthcare, and institutional levels influence individuals' experiences of empowerment and abandonment in self-managing endometriosis? Participants will describe the everyday actions they take to live with endometriosis, through diary studies, interviews, and focus groups.

Participants needed: 150
Trial details
Age: 16+Biological sex: FemaleType: ObservationalSponsor: Wageningen University and ResearchUpdated: May 15, 2026Locations: 1
Eligibility criteria

living in a European country [+3]

not meeting one of the inclusion criteria

Status: Recruiting

OPtimizing Technology to Improve Medication Adherence and BP Control (OPTIMA-BP)

Hypertension (HTN) has a greater impact on African Americans (AA) than any other U.S. racial group. Uncontrolled blood pressure (BP) contributes to higher rates of disability, death, and health resource use among AA. HTN is the single most influential risk factor for cardiovascular disease (CVD), as well as a risk factor for the incidence of stroke, diabetes, chronic kidney disease, and dementia. Importantly, older adults account for 15% of the U.S. population, and two-thirds of older adults over age 60 have HTN, with higher rates observed in AA older adults. Strategies to support self-managing HTN and BP control are crucial as the older population is projected to age considerably and become more racially and ethnically diverse. Research has documented the negative effects on health and health outcomes of poorly controlled BP and is one of the most important modifiable CVD risk factors. Lower BP targets will require aggressive management and an increase in antihypertensive medications. Therefore, to achieve lower targets in this population, greater efforts, including patient-centered methods will be needed to support self-managing HTN, especially in terms of medication adherence. As we shifted into the digital age, the use of mHealth technologies (smart phones, applications, SMS or text messaging) has been a powerful approach and mechanism for the treatment and management of chronic diseases. However, behavioral interventions that incorporate technology do not reach minorities or disadvantaged AA older adults with HTN. OPtimizing Technology to Improve Medication Adherence and BP Control (OPTIMA-BP) will leverage existing knowledge of effective technology-based components for HTN self-management to support and improve BP control using unique aspects of mHealth platforms in AA older adults. Findings from this study, if confirmed, will improve BP control and support self-managing HTN, as well as has the potential to close the health disparity gap between AA and non-AA older adults with HTN.

Participants needed: 208
Trial details
Age: 50+Biological sex: AllType: InterventionalSponsor: Case Western Reserve UniversityUpdated: Apr 3, 2026Locations: 1
Eligibility criteria

Self-identify as African American [+5]

Unable to give informed consent or judged to have impaired cognitive ability or... [+3]

Status: Not yet recruiting

Dyadic Management Intervention in Older People With Co-occurring Cognitive Impairment and Diabetes as a Supplementary Approach to Chronic Diseases Self-Management Program

The goal of this study is to evaluate the effectiveness and implementation of a dyadic management of the Chronic Disease Self-Management Program (CDSMP) for older adults with co-occurring cognitive impairment and diabetes with the involvement of caregivers. The main questions it aims to answer are: * Does the intervention improve diabetes self-management and cognitive function in older adults? * How is the implementation of the intervention in real-world settings? Participants will: * Attend weekly CDSMP session over a 6-week period (2.5-hour per session). * Provide feedback on their experience with the intervention through interviews and surveys.

Participants needed: 309
Trial details
Age: 55+Biological sex: AllType: InterventionalSponsor: The Hong Kong Polytechnic UniversityUpdated: Mar 27, 2026
Eligibility criteria

Individuals with DM aged >= 55 years old; [+4]

Medical diagnoses of dementia; [+2]

Status: Recruiting

Nudge-Based Shared Decision Making and Self-Management in Type 2 Diabetes: A Randomized Trial

This study aims to test whether a communication strategy called "linguistic nudging" can help doctors and patients with type 2 diabetes make better treatment decisions together, and whether this improves patients' ability to manage their condition. What will happen in the study? - 250 adults with type 2 diabetes from Xiang'an Hospital (Xiamen) will be randomly assigned to one of two groups: Intervention group:Doctors will receive special training in "linguistic nudging" techniques to encourage shared decision-making. Patients will use a mobile app to record medication preferences, and doctors will adjust advice based on these preferences. Control group:Patients will receive standard diabetes care without these additional strategies. \- All participants will be followed for 6 months. What is the study aiming to find out? The main goal is to see if patients in the intervention group: Better follow medication plans Improve blood sugar monitoring Have better blood sugar control Feel more satisfied with doctor-patient communication Why is this important? Good self-management is key to controlling diabetes, but many patients struggle with it. Effective communication during shared decision-making may empower patients to manage their condition day-to-day with greater confidence. Patient safety and rights: Participation is completely voluntary All personal information will be kept strictly confidential Medical support will be provided if any health problems occur during the study Participants may withdraw at any time This research has been approved by the Ethics Committee of Xiang'an Hospital (Approval date: October 2025).

Participants needed: 250
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Yunxuan LiUpdated: Nov 28, 2025Locations: 1
Eligibility criteria

Confirmed diagnosis of type 2 diabetes [+4]

Severe acute complications (e.g., ketoacidosis, hyperosmolar coma) [+4]

Status: Not yet recruiting

Self-management Digital Intervention to Promote Physical Activity in People Living With COPD

The goal of this pilot randomized controlled trial is to evaluate the feasibility, acceptability, and preliminary effects of a theory-based self-management digital intervention (Respir'air BPCO) designed to promote physical activity in patients with Chronic Obstructive Pulmonary Disease (COPD) after completion of a pulmonary rehabilitation program. The main question it aims to answer is: Is the Respir'air BPCO intervention (mobile app) feasible, acceptable, and preliminarily effective in increasing physical activity, enhancing self-management, improving motivation, and quality of life, while reducing dyspnea severity, exacerbations, and hospitalizations, compared with no additional intervention? Researchers will compare an experimental group (receiving the Respir'air BPCO intervention + usual care) to a control group (no additional intervention, only usual care) Participants will: Be assigned either to the control group, receiving no additional intervention beyond usual care (traditional pulmonologist follow-up), or to the experimental group, receiving access to the Respir'air BPCO mobile app in addition to usual care. * Complete baseline assessments immediately after finishing their in-person pulmonary rehabilitation program. * Complete follow-up assessments at 3 months and 6 months after the start of the intervention

Participants needed: 50
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Institut et Haute Ecole de la Santé la SourceUpdated: Dec 3, 2025Locations: 1
Eligibility criteria

a GOLD COPD diagnosis stage 1 to 4, classification B or E; [+7]

clinical instability confirmed by the team of healthcare professionals; [+3]

Status: Not yet recruiting

WhatsApp-Based and Family-Involved Diabetes Self-Management Education Study

The aim of this study is to evaluate the effects of a WhatsApp-based and family-involved self-management education program on self-management, family support, and HbA1c levels among individuals with type 2 diabetes mellitus (T2DM). Hypotheses: * H1: There will be a significant difference in self-management scores between the intervention group receiving the WhatsApp-based and family-involved self-management education and the control group. * H2: There will be a significant difference in HbA1c levels between the intervention group receiving the WhatsApp-based and family-involved self-management education and the control group. * H3: There will be a significant difference in family support scores between the intervention group receiving the WhatsApp-based and family-involved self-management education and the control group. This randomized controlled trial will be conducted with 44 individuals diagnosed with T2DM who meet the inclusion criteria and one family member per participant (total 88 participants). Eligible patients will be randomly assigned to either the intervention or control group using a computer-generated randomization list. Participants (people with diabetes and their family members) in the intervention group will receive a 12-week, WhatsApp-based self-management education program. Educational modules (videos, visuals, and written materials) will be shared separately with each person with diabetes and their participating family member via WhatsApp twice a week. To reinforce learning, a five-question quiz will be sent separately to both the person with diabetes and the family member every Thursday. In addition, a brief follow-up phone call (approximately 10 minutes) will be conducted once a week only with the person with diabetes to review progress and provide feedback. Data collection will occur at baseline and at the end of the 12th week. Participants in the control group will continue their routine outpatient follow-ups for three months and complete the same measurement tools at baseline and post-intervention. Data will be collected using the Diabetic Participant Demographic Form, Family Member Demographic Form, Diabetes Self Management Questionnaire, Hensarling's Diabetes Family Support Scale, and the Diabetes Knowledge Scale for Adults. Statistical analyses will be performed using SPSS software. Group comparisons will be analyzed with independent t-tests or Mann-Whitney U tests, and pre-post comparisons with paired t-tests or Wilcoxon tests. A significance level of p\<0.05 will be used.

Participants needed: 88
Trial details
Age: 18-74Biological sex: AllType: InterventionalSponsor: Koç UniversityUpdated: Nov 21, 2025Locations: 1
Eligibility criteria

Not listed

Status: Recruiting

The Effect of Motivational Interviewing on Diabetes Self-Management and Severity of Cyberchondria in Individuals With Diabetes

Objective: The aim of this study was to determine the effects of diabetes education given to individuals with diabetes using motivational interviewing technique based on the health promotion model on diabetes self-management and cyberchondria severity. Materials and Method: The population of the study consisted of 1000 individuals. The sample consisted of 64 individuals, 32 experimental and 32 control, who met the research criteria. The research will be conducted between 15.02.2025-15.03.2025 in Van Regional Training and Research Hospital Diabetes outpatient clinic. Data in the research; Descriptive Information Form, Diabetes Self-Management Scale (DMS), Cyberchondria Severity Scale-Short Form (CSS-SF) scales will be applied. Research experiment Motivational interviewing intervention based on the health belief model will be conducted once a week for 1 month. At the end of 1 month, both scales will be administered again to individuals in both experimental and control groups.

Participants needed: 64
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Ataturk UniversityUpdated: Apr 30, 2025Locations: 1
Eligibility criteria

Having diabetes for at least 6 months [+5]

Being under 18 years of age [+3]

Status: Not yet recruiting

Development and Evaluation of a Culturally Sensitive Structured Diabetes Self-Management Program for People With Type 2 Diabetes Residing in Qatar

This study is about helping people in Qatar who have Type 2 Diabetes take better care of their health. Diabetes is a common and growing problem in Qatar, and many people need more support and information to manage it well in their daily lives. Right now, there is a program called DESMOND in Qatar, but it is only available in a few places and can be expensive to run. It also doesn't always work well in the long term. That's why we are creating a new diabetes education program called PARADIGM-Q. This program will be easier to access, more affordable, and designed to match the culture and needs of people living in Qatar. The PARADIGM-Q program will teach people how to manage diabetes using real-life examples and group discussions. This method is called Case-Based Learning. It helps people understand their condition better and learn how to make good decisions about food, exercise, medication, and dealing with challenges. The project will happen in two main phases: Phase One: Understanding and Creating the Program In the first part, we'll look at different ways of teaching about diabetes and see if a method called Case-Based Learning (CBL) works well. After that, we'll build a curriculum (a plan for teaching) based on the PARADIGM model. This curriculum, called the PARADIGM-Q program, will use the CBL method to teach. We'll also test this new program with a small group of diabetes educators and people with diabetes to make sure it works well. Their feedback will help me make the program even better. Phase Two: Testing the Program In the second part, we'll do a big study using a mix of people from different backgrounds in Qatar who have Type 2 Diabetes. we want to see if the PARADIGM-Q program is better than the program they already have (called DESMOND). we'll look the impact of our new program on different things like how much they know about diabetes, how active they are, their blood sugar levels (HbA1C), and their overall quality of life. This study could lead to a new standard for diabetes education in Qatar and other countries in the region, helping more people live healthier lives with diabetes.

Participants needed: 200
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: Ragae DughmoshUpdated: Apr 29, 2025
Eligibility criteria

Adults aged 18 to 65 years. [+5]

Diagnosed with any type of diabetes other than Type 2. [+4]

Status: Not yet recruiting

Artificial Intelligence-Supported Mobile Application For Diabetes Self-Management

Patients in the AI-supported mobile application group will be able to log in with a username and password that will be defined specifically for them. Patients will be informed about how the application is used during their first interview. They will enter their personal and disease characteristics (age, gender, height, weight, HbA1C, HDL, LDL) into the application at the entrance. Other sections of the application will include exercise, nutrition, medication tracking, complication tracking and diabetic foot care sections. The person will be asked to enter relevant information in these fields according to their own life and condition (for example; how many times do you use insulin per day, what are your medication times, how do you spend your day in terms of exercise, how many meals do you eat, what is your diet, do you urinate frequently, are you extremely thirsty, are you hungry often, do you have numbness in your hands and feet, etc.). After the patient enters the necessary information, they will also be asked to enter their daily blood sugar measurement values into the system. Thus, the individual\&amp;#39;s hypo/hyperglycemia risk, risk analysis, nutrition recommendations, medication reminder system, exercise reminder and incentive warnings will be communicated to the individual thanks to the AI-based mobile application. The aim of this application is to reduce the risk of complications and improve the individual\&amp;#39;s quality of life by providing personalized recommendations for all the needs of the individual, including alarms and reminders, and to support patients to continue their diabetes education and disease management more actively.

Participants needed: 156
Trial details
Biological sex: AllType: InterventionalSponsor: Uludag UniversityUpdated: Mar 25, 2025Locations: 1
Eligibility criteria

Having been diagnosed with diabetes for at least 1 year [+5]

Having a perception disorder and psychiatric disorder that prevents the patient... [+4]

Status: Recruiting

A Digital Health Intervention to Promote Self-management in Patients With Chronic Obstructive Pulmonary Disease

Dyspnea, cough, and chronic mucus hypersecretion are common symptoms in patients with Chronic Obstructive Pulmonary Disease (COPD), which increases risk of infections followed by exacerbations, often leading to hospitalization, disease progression and mortality. This patient group requires lifelong treatment in healthcare. A mobile application was developed to facilitate adherence to evidence-based guidelines for tailored breathing and airway clearance techniques to enhance self-management. The app is only in Norwegian and has a Norwegian name which is "Pust Deg Bedre" (PDB). The PDB app is fully developed and tested and can be downloaded for free. The app seems promising as a treatment tool, but has not yet been clinical evaluated. This project aims to 1) explore the feasibility of providing the app for patients with COPD, 2) explore the patients' with COPD experiences with the use of the PDB-app in treating dyspnea and mucus secretion, 3) explore the physiotherapists' experiences with the use of the PDB-app in treating dyspnea and mucus secretion, 4) explore the physiotherapists' experiences with implementing the PDB-app in treatment of patients with COPD, 5) explore the patients' experiences with the education in use of the PDB-app, and 6) At a 6-month follow up: explore the physiotherapists experiences with the usefulness and applicability of PBD-app, and to generally explore their experiences with participating in the project.

Participants needed: 90
Trial details
Age: 18-90Biological sex: AllType: InterventionalSponsor: Western Norway University of Applied SciencesUpdated: Feb 28, 2025Locations: 1
Eligibility criteria

Clinical diagnosis of Chronic Obstructive Pulmonary Disease [+3]

Severe mental illness [+1]

Status: Not yet recruiting

Electronic Patient Decision Support System for Patients with Type 2 Diabetes (DiaPaDeSS)

This study evaluates the effects of an electronic patient decision support system developed for the use of patients with type 2 diabetes (DiaPaDeSS) on self-management, patient activation, and metabolic parameters. To manage type 2 diabetes after discharge, patients must continue to perform interventions at home, such as blood glucose monitoring, blood pressure measurement, weight measurement, medication use, and foot care. To achieve this, patient's self-management and activation levels should be increased. This can also lead to positive improvements in the metabolic parameters. It would be beneficial to develop DiaPaDeSS that can increase the self-management and activation levels of patients with type 2 diabetes. The investigators will develop the DiaPaDeSS intervention protocol. Our content includes patient education information about type 2 diabetes, self-management practice tasks (daily, weekly, quarterly), a type 2 diabetes patient education program according to DiaPaDeSS algorithms, and measurement questionnaires. The content of the DiaPaDeSS will be evaluated by 10 experts in the fields of medicine, nursing, and informatics. A feasibility test with seven patients will be conducted to evaluate the usability of DiaPaDeSS. A single-blind, randomized controlled trial design will be used. Patients with type 2 diabetes will be pretested and randomized (intervention 36, control 36) to the DiaPaDeSS intervention and control groups. Both the DiaPaDeSS intervention and control groups will use the DiaPaDeSS for three months. While participants in the DiaPaDeSS intervention group can reach all contents of the DiaPaDeSS, others can reach only these fields: self-management practice tasks (daily, weekly, quarterly), and measurements questionnaires. The effectiveness of the DiaPaDeSS will be evaluated at baseline and at month 3.

Participants needed: 72
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: Akdeniz UniversityUpdated: Feb 6, 2025Locations: 1
Eligibility criteria

Patients with type 2 diabetes who had been followed up and treated at the Endocr... [+7]

Diagnosed with myocardial infarction, stroke or diabetic foot in the last six mo... [+7]

Status: Recruiting

Effect of Health Diary on Self-management in Adolescent Patients With Fixed Orthodontic Appliance

This study aims to use two-arm randomized clinical trials to evaluate the effectiveness of the health diary in helping adolescents wearing fixed orthodontic appliances improve their oral hygiene status, self-management skills, oral health-related quality of life, self-efficacy, intention,number of breakages, and on-time and return visit status.

Participants needed: 140
Trial details
Age: 12-18Biological sex: AllType: InterventionalSponsor: Wei XIA, PhDUpdated: Jul 25, 2024Locations: 1
Eligibility criteria

Patients with malocclusion eligible for fixed appliance orthodontic treatment; [+4]

The patient's disease was diagnosed as jaw deformity associated with other disea... [+2]

Status: Not yet recruiting

Effects of a Health Intervention on Fear of Hypoglycemia

To examine the effects of a health Education Intervention based on the Behaviour Change Wheel (BCW) theory on fear of hypoglycemia and relevant outcomes of type 2 diabetic patients.

Participants needed: 90
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Yangzhou UniversityUpdated: Jul 9, 2024Locations: 1
Eligibility criteria

Comply with the 2020 Chinese guidelines for the prevention and treatment of type... [+6]

Patients with comorbid acute complications or other serious diseases or disorder... [+2]

Status: Not yet recruiting

Mitigating Toxicity by Electronic Health Portal-mediated Interactive Monitoring of Patient-reported Side Effects

Chemotherapy induces side effects varying in severity, impacting patients' quality of life and necessitating unplanned hospital care. Patient-reported outcomes (PROs) could aid in early detection and management of side effects. However, existing PRO monitoring lacks triage capabilities, leading to clinician involvement and suboptimal symptom management. The investigators propose eChemoCoach, an electronic questionnaire integrated into the electronic health portal, offering real-time symptom assessment and personalized advice based on CTCAE criteria. Our study aims to assess the impact of eChemoCoach on non-hematological CTCAE ≥ 3 graded side effects in early breast cancer patients undergoing chemotherapy. This is a randomized controlled trial involving 746 patients that will evaluate the eChemoCoach's efficacy compared to standard monitoring. Phase one will validate questionnaires and assess usability, while phase two focuses on the primary outcome. Te investigators anticipate reduced severe side effects, thereby enhancing patients' quality of life, reducing stress, and minimizing hospital visits.

Participants needed: 746
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Noordwest ZiekenhuisgroepUpdated: May 21, 2024
Eligibility criteria

Four cycles of doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 (AC) dose dense... [+5]

- Participation in a trial with an investigational product (because more frequen... [+2]