Telerehabilitation and Tele-psychological Support in Cancer Patients: the Pilots Projects of eCAN JA
The integration of teleconsultation (TC) and telemonitoring (TM) in cancer patients care may allow to improve person-centered care and patients' empowerment. The eCAN JA explores the role of telemedicine tools (i.e. TC & TM) in clinical trials focusing on tele-rehabilitation and tele-psychological support in different populations of cancer patients in 10 European countries. The pilots will be conducted among 354 patients affected by breast (BC, pilot 1a), head & neck (H&N, pilot 1b) and advanced (pilot 2) cancers. The main aim is to assess the effect of TC and TM program focused on rehabilitation and psychological support for cancer patients on patient reported outcomes measures (PROMs) in three pilots compare to usual care. Patients will be randomly assigned either to the intervention or control groups using a 1:1 ratio. Patients in the intervention group will receive weekly TC of 30 minutes during 8 weeks through the secure Edumeet platform. In pilot 1, tele-rehabilitation training will be performed by a remote physiotherapist and will consist of a series of rehabilitation exercises. In pilot 2, tele-psychological support will be performed by a remote psychologist and will consist of techniques for managing emotions and stress. In the intervention group, patients will also have the possibility to wear a smartwatch to automatically collect physical parameters. Patients in the control group will receive usual care. PROMs (i.e. quality of life, distress and pain) and physical parameters (i.e. physical activity, sleep quality and heart rate) will be monitored by a dedicated telemonitoring systems. A secure web platform will provide dashboard to clinicians for decision support. Patients' experience and costs data will be also collected. The results of the eCAN project will improve our knowledge on benefits and risks for TC and TM in cancer patients care.
NCT06007001 — Cancer
Status: Recruiting
http://inclinicaltrials.com/cancer/NCT06007001/
Randomized and Multicenter Study to Evaluate the Impact of a Customizable Support Material in the Knowledge and Satisfaction of Breast Cancer Patients
The goal of this clinical trial is to evaluate if a customizable support material allows to improve the knowledge about the stage and subtype of the disease, as well as the indicated treatments, in comparison with a non-customizable support material among patients with breast cancer. The main question it aims to answer is: • What is the impact of delivering a customizable support material so that patients with breast cancer know and remember the stage and subtype of their disease, as well as the indicated treatments, compared to non-customizable support material? Participants in the intervention group will be provided customizable support material while those in the standard group will receive a non-customizable material.
NCT05798312 — Breast Cancer
Status: Completed
http://inclinicaltrials.com/breast-cancer/NCT05798312/
Green Approach to Improved Nutritional Support for Cancer Patients
In this study, we aim to reduce the burden of malnutrition in cancer patients by implementing and evaluating an improved nutritional support, using digital communication and registration tools during the clinical pathway. The project targets a group of patients with a high frequency of malnutrition, due to cancer and the subsequent therapy, where knowledge on the efficient and cost-effective treatment is scarce. The effect of the improved nutrition support will be evaluated in a randomised controlled trial, and the primary endpoint is the prevalence of malnutrition. The long-term goal is to benefit the patients by increasing the completion rate of cancer treatment, reducing the infection rate, need for antibiotics, the total length of hospital stays and number of non-elective re-admissions, and thus increasing the patients' quality of life and survival. The project will be patient-orientated and result in a sustainable approach for the management of malnutrition.
NCT05544318 — Malnutrition
Status: Recruiting
http://inclinicaltrials.com/malnutrition/NCT05544318/
Development of Motion-Model Ultrasound Localization Microscopy to Support Breast Cancer Diagnosis and Therapy Monitoring in Patients
The goal of this project is to adapt the super-resolution ultrasound imaging technology motion-model Ultrasound Localization Microscopy (mULM) to clinical application. In this exploratory patient study a scan protocol will be established to subsequently investigate whether mULM allows the assessment of the tumor response to neoadjuvant chemotherapy in participants with a primary breast cancer diagnosis as well as for the differentiation of benign and malignant breast tumors in participants with lesions of unknown dignity.
NCT05445050 — Primary Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/primary-breast-cancer/NCT05445050/
PROSAIC-DS (PROState AI in Cancer - Decision Support): Evaluation of the Deontics AI Platform for Evidence-based Treatment Planning in Multidisciplinary Cancer Care: Increasing Compliance and Streamlining MDTs in Prostate Cancer
Around 375,000 cancers are diagnosed in the UK annually, with this figure expected to reach 500,000 by 2035. As the number of different cancer treatment options and our scientific understanding continue to grow rapidly, it can be difficult for clinicians to keep up-to-date with best practice, causing unjustified variations in the quality of care and clinical outcomes for patients. Currently, when a patient has been referred to and seen by a clinician, their treatment is then discussed in a Multi-Disciplinary Team Meeting (MDTM). MDTM is a meeting of medical experts, including Surgeons, Oncologists, Nurses, and specialists in cancer, imaging and diagnosis. This is the case even if a treatment decision is straightforward. A nationwide review published by CRUK in 2017 highlighted the demands on cancer teams and the MDTM process: - Increased caseloads are causing dramatic increases in the time spent by clinicians in MDTMs, leading to an unsustainable rise in costs: the cost in England has increased from £88m to £159m in 4 years; - There is not enough time in the MDTM to discuss complex cases; - There is a failure to involve patients in the decision-making process: around 75% of patients feel their views are unrepresented in MDTMs; In our study we are looking at the potential of technology - particularly Clinical Decision Support Systems (CDSS) - to improve MDTM decision making. Deontics has a CE marked AI-based CDSS that integrates individual patient data and preferences with evidence-based clinical guidelines. This dynamically and transparently generates best-practice, individualised treatment recommendations which can help determine treatment. Deontics' AI tool has already been shown to provide personalised recommendations concordant with UK best practice while incorporating patient values, and can be used to safely triage less complex patients straight to treatment with minimal clinical oversight. Our project partners with Deontics to develop PROSAIC-DS - A CDSS for prostate cancer.
NCT05355727 — Prostate Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/prostate-cancer/NCT05355727/
Mobile Health Technology for Personalized Tobacco Cessation Support Among Cancer Survivors in Laos
The parent project (1R21CA253600-01, R21 phase: 9/1/2020-8/31/2022, R33 phase: 9/1/2022-8/31/2025) aims to adapt and evaluate the efficacy of our theoretically and empirically based mobile health (mHealth) technology to help general patients in Lao People's Democratic Republic (Lao PDR) quit smoking cigarettes. This mHealth automated treatment (AT) approach includes a fully automated, interactive, personalized, smartphone-based intervention for behavioral treatment, delivered through our Insight platform. The purpose of this projects to expand our mHealth-based intervention to address the pressing need for smoking cessation among cancer survivors and their caregivers in Lao PDR. In this project, the investigators will further adapt the AT intervention to ensure that its content is comprehensible and relevant to the target populations (i.e., cancer survivors and caregivers). Then, the investigators will conduct a pilot randomized controlled trial (RCT, N=80) to evaluate the preliminary efficacy of the intervention. Cancer survivors (n=40) and caregivers (n=40) of both sexes who smoke will be identified via medical records at the Setthathirath Hospital (SH) and Lao National Cancer Center (LNCC) and recruited. Similar to the parent project's design, participants will be randomized to 1 of 2 treatment groups: standard care (SC) or AT (20 cancer survivors and 20 caregivers in each group). SC consists of brief advice to quit smoking delivered by research staff, self-help written materials, and a 2-week supply of nicotine patches. AT consists of all SC components plus our fully-automated interactive smartphone-based treatment program, personalized and tailored to cancer survivors or caregivers. The primary RCT outcome is biochemically confirmed self-reported 7-day point prevalence abstinence at 3 months post-study enrollment. The specific aims are as follows: Aim 1: Evaluate the feasibility of AT in cancer survivors and caregivers. Hypothesis (H1): ≥75% of AT content will be viewed/opened as indicated by digital date/time stamp in Insight. Aim 2: Evaluate the preliminary efficacy of AT in each cancer survivor/caregiver subgroup. Hypothesis (H2): At the 12-week follow-up, 7-day point prevalence abstinence will be higher in the AT (vs. SC) group.
NCT05253573 — Cigarette Smoking
Status: Completed
http://inclinicaltrials.com/cigarette-smoking/NCT05253573/
Development and Evaluation of a PROMs-based Interactive Programme as a Supporting Tool for Breast Cancer Patients Using Adjuvant Endocrine Therapy
The objective of the study is to evaluate the effect of an online tool, based on patient reported outcomes (Co'moon), on the quality of life of breast cancer patients on adjuvant endocrine therapy in the University Hospital Leuven.
NCT05085678 — Breast Cancer
Status: Completed
http://inclinicaltrials.com/breast-cancer/NCT05085678/
The Feasibility of a Remote Maintenance Exercise Program for Cancer Survivors Supported by Health Coaching.
The feasibility of an online maintenance exercise program for cancer survivors supported by health coaching.
NCT04751305 — Cancer Survivors
Status: Completed
http://inclinicaltrials.com/cancer-survivors/NCT04751305/
Preference-based Decision Aid to Support Participatory Decisions About Tumor-specific and Palliative Therapy in the Last Months of Life
To support advanced cancer patients, for whom standard therapy is no longer available, and their oncologists in therapy decisions, the investigators aim to develop a decision-making aid (DA) in a multi-phased bicentric study. The DA aims to help patients to understand better risks and benefits of available treatment options including the options of standard palliative care, off-label drug use within an individual treatment plan and involvement in early clinical trials.
NCT04606238 — Advanced Cancer
Status: Recruiting
http://inclinicaltrials.com/advanced-cancer/NCT04606238/
Evaluating Education Tools to Support Pediatric Cancer Survivor Care Across the Lifespan (Administrative Supplement to R01CA218389)
This study aims to evaluate the impact of electronic educational materials on adolescent and young adult ("AYA") survivors' knowledge about late effects, perceived benefits, self-efficacy, and intentions to engage in lifelong survivor care.
NCT04257058 — Cancer
Status: Recruiting
http://inclinicaltrials.com/cancer/NCT04257058/