Design and Evaluation of the Effectiveness of a Digital Health Intervention to Improve Health Care and Outcomes for Cancer Patients
Background: Nearly 30,000 Mexican women develop breast cancer annually. These patients frequently present multiple unmet supportive care needs. In high-income settings, incorporating electronic patient-reported outcomes (ePROs) into cancer care has demonstrated potential for increasing patient-centred care and reducing unmet needs. No such ePRO interventions have been implemented in Mexico. The objectives of this study are (I) to design a two-component intervention for monitoring ePROs among breast cancer patients using a responsive digital application and proactive follow-up by nurses, (II) to perform intervention pilot testing of the study materials, and (III) to conduct the clinical trial to assess usability and effectiveness of the intervention. Methods. The investigators designed a two-component intervention for women receiving breast cancer treatment: a responsive web application for monitoring ePROs and clinical algorithms guiding proactive follow-up by nurses. The investigators will conduct a pilot test of the intervention with 50 breast cancer patients for six weeks to assess the feasibility and inform intervention adaptations. After that, the investigators will conduct a parallel arm randomized controlled trial assigning 205 patients each to intervention and control in one of Mexico's largest public oncology hospitals. The intervention will be provided for six months, with additional three months of post-intervention observation. The control group will receive usual healthcare and a list of information sources on relevant breast cancer topics. Women diagnosed with stages I, II, or III breast cancer who initiate chemo and/or radiotherapy will be invited to participate. The study outcomes will include supportive care needs, quality of life, use of emergency services and unscheduled hospitalizations, the usability of the ePRO App, and adherence to the intervention. Information on the outcomes will be obtained through web-based self-administered questionnaires collected at baseline, 1, 3, 6, and 9 months.
NCT05925257 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT05925257/
SPECT Imaging of Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Breast Cancer Using Iodine -123-labelled Designed Ankyrin Repeat Proteins HE3-G3 ([123I] I-(HE)3-G3)
The study should evaluate distribution of [123I] I-(HE)3-G3 in patients with primary HER2-positive and HER2-negative breast cancer
NCT05923177 — Primary Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/primary-breast-cancer/NCT05923177/
A Cohort Study of Musculoskeletal Health in Patients With Breast Cancer During Aromatase Inhibitors Therapy
Postmenopausal women with hormone receptor-positive breast cancer are now prescribed aromatase inhibitors with 5 years or longer durations of therapy as recommended by clinical guidelines, which contributes to reducing breast cancer recurrence. However, aromatase inhibitors treatment is associated with a high incidence of musculoskeletal symptoms (MSS), often described as symmetrical pain, soreness in the joints, musculoskeletal pain, and joint stiffness, which even leads to bone loss, osteoporosis, and fractures. MSS reduces patients' quality of life and compliance with aromatase inhibitors therapy in up to one-half of women undergoing adjuvant aromatase inhibitors therapy, potentially compromising breast cancer outcomes. Therefore, this study aimed to monitor the musculoskeletal health of breast cancer patients during endocrine therapy to provide references for clinical practice.
NCT05921617 — Musculoskeletal Health
Status: Recruiting
http://inclinicaltrials.com/musculoskeletal-health/NCT05921617/
Mobile Medical Application on Adjuvant Therapy Compliance and Quality of Life in Patients With Early Breast Cancer: a Multicentric, Open-labeled, Randomized Controlled Trial
The goal of this multicentric randomized controlled clinical trial is to test the role of mobile medical application (APP) on adjuvant therapy compliance and quality of life (QoL) in patients with early breast cancer. Participants assigned to the Ruijin Breast Cancer APP (RJBC-APP) group can receive treatment reminders, matters needing attention as well as science knowledge and they can communicate with the medical staff during adjuvant treatments while follow-up can only be conducted in outpatient clinic for those in the Control group.
NCT05921331 — Breast Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/breast-cancer/NCT05921331/
Therapeutic Mammoplasty Doesn't Delay Adjuvant Therapy for Breast Cancer Patients
the purpose of this study was to examine the impact of therapeutic mammoplasty on the delivery of adjuvant chemotherapy
NCT05920070 — Effect of Therapeutic Mammoplasty on Adjuvant Chemotherapy
Status: Completed
http://inclinicaltrials.com/effect-of-therapeutic-mammoplasty-on-adjuvant-chemotherapy/NCT05920070/
Realistic Evaluation of a Job Retention Program After Breast Cancer
Returning to and maintaining employment after cancer is essential for restoring social participation, financial independence and reducing the social costs associated with cancer. Many obstacles that prevent or delay the return to work have been identified. They are associated with the consequences of the disease and treatments such as fatigue, pain and cognitive disorders, the lack of collaboration between health professionals (oncologists, general practitioners and occupational physicians), and the characteristics of the environment. in terms of the demands of the job, and the (lack of) social support from superiors and colleagues. There are social inequalities in the return to work after cancer, with a poorer professional prognosis among older and less qualified people. Social inequalities linked to ethnicity have been documented in other countries. In France, 58,500 new cases of breast cancer are diagnosed each year, half of them in women of working age. The importance of job retention has been formalized in the objectives of the latest cancer plans, and in the 2018-2022 national health strategy. Initiatives are observed to promote this issue by employers: development of a charter by the National Cancer Institute and in the associative field aimed at promoting support practices in their professional environment for people with cancer. Despite the development of descriptive knowledge on prognostic factors for returning to work after cancer, the results of interventional studies are mixed. No intervention has been shown to be effective in facilitating return to work and reducing social disparities in employment after breast cancer. Interventions have been criticized for being too medicalized and lacking a sufficient theoretical basis to analyse causes (theory of the problem) and propose solutions (theory of action). The "FASTRACS" intervention was developed with the Intervention Mapping protocol to facilitate the return to work after breast cancer, it defines a return-to-work path from the hospital to the company through care primaries. This intervention is anchored in primary care with an early transition consultation in general medicine in the month following the end of active treatments (chemotherapy or radiotherapy according to the care protocol). This positioning in primary care allows a bio-psycho-social assessment of the needs of women after cancer. This consultation was designed to establish a plan of care and return to work according to the temporality and individual needs of each woman. It will make it possible to determine the right time for the pre-recovery visit in order to anticipate the professional challenges of the recovery. Return to work/maintenance in employment interventions are complex social interventions, implemented by social actors who act in an environment with which they interact. These interventions (or programs) present an increased risk of failure in their implementation and sustainability. Realistic evaluation comes from the trend of theory-based evaluation (theory-based or theory-driven evaluation). According to this approach, social interventions are based on theories, which can be tested through empirical observation to better understand how and why they produce their effects, and in what context. This approach overcomes the limits of the "black box" model. It is recommended to inform the public decision to interrupt, modify or intensify an intervention. It aims to answer the question: "what works, how, why, for whom, and under what circumstances?" ". It aims to describe the mechanisms of the effectiveness of an intervention by linking its effects to the characteristics of its implementation context (search for CME configurations = context - mechanisms - effects). The search for these configurations, otherwise called "half-regularities" because they can be observed empirically with certain variations, is intended to develop a middle-range theory with a sufficient level of generalization and abstraction. to explain the tendencies and the regularities observed in the interactions contexts-mechanisms-effects of the intervention. This approach is particularly indicated in the evaluation of the FASTRACS intervention, given the complexity of the intervention, the number of actors involved, and the variety of its implementation contexts.
NCT05919498 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT05919498/
Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers
This phase II trial tests how well neratinib prior to the primary treatment (neoadjuvant) works in treating patients with stage I-III HER2 mutated lobular breast cancers. Neratinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving neratinib in addition to normal therapy may work better in treating cancer than the endocrine therapy patients would normally receive.
NCT05919108 — Invasive Breast Lobular Carcinoma
Status: Recruiting
http://inclinicaltrials.com/invasive-breast-lobular-carcinoma/NCT05919108/
Managing Breast Cancer Treatment: Dyad's Perspectives on Treatment Decision, Financial and Family Burden.
The purpose of this study is to understand the financial burden and treatment decisions, based on both of patient's and family's perspectives in breast cancer patients who receive systemic chemotherapy, targeted therapy or immuno-therapy and their family caregivers .
NCT05917444 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT05917444/
Identification of Predictive Biomarkers of Response to Chemotherapy and Immune Checkpoint Inhibitors in Early Triple Negative Breast Cancer: an Integrative Multiomics Platform
Patients with stage II-III Triple negative breast cancer (TNBC) candidates to receive neoadjuvant chemotherapy (NACT) +/- immune checkpoint inhibitor (ICI) will be included. Several samples from different tissues will be analyzed through different omics to establish predictive biomarkers of response to the treatment. Multiple algorithms will then be used to look for an integrative predictive algorithm that incorporates multi-parameter inputs in order to develop a clinical tool to assist clinicians in the process of treatment decision-making in TNBC.
NCT05916755 — Triple Negative Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/triple-negative-breast-cancer/NCT05916755/
SOLUS Smart Optical and Ultrasound Diagnostic of Breast Cancer
SOLUS is a trans-disciplinary 48-month project bringing together 9 partners: industries (4), academic and clinical institutions from 5 countries (engineers, physicists and radiologists) representing cutting-edge expertise in their fields, to develop an innovative non-invasive, point-of-care, low-cost, easy-to-operate, multi-modal imaging system (diffuse optics and ultrasounds/shear wave elastography) for high-specificity diagnosis of breast cancer, the most common female cancer in Europe. Mammographic screening is effective in reducing mortality, however the 10-year cumulative false-positive risk is 50-60%, leading to needless additional invasive procedures (e.g. biopsy). The project addresses the unmet clinical need for higher specificity in breast cancer imaging following screening by fully combining photonics with non-photonics techniques, developing and clinically validating innovative and previously unthinkable photonics concepts and components: time-domain small source-detector distance optical tomography, miniaturized picosecond pulsed laser sources, high-dynamic-range time-gated single-photons detectors to achieve unprecedented sensitivity and depth penetration. For the first time, this allows a comprehensive quantitative characterization of breast tissue including composition (water, lipids, collagen), functional blood parameters, morphologic information and mechanical parameters (stiffness). This innovative multi-parametric characterization will significantly improve the specificity of breast screening, with great impact on the quality of life of millions of European women every year, and huge savings for the healthcare systems. The strong involvement of leading industrial players at all levels in the value chain will push the European innovation process and make a significant contribution to ensuring Europe's industrial leadership in the biophotonics healthcare market, while addressing one of the largest societal challenges in health and well-being.
NCT05916703 — Breast Disease
Status: Recruiting
http://inclinicaltrials.com/breast-disease/NCT05916703/