E-Health Solutions for Breast Cancer
(ABODE Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University Health Network, Toronto
Disqualifiers: Males, Non-operable cancer, Metastatic, others
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?This trial tests a smartphone app for newly diagnosed breast cancer patients to help manage their care remotely. The app allows virtual consultations, provides educational materials, and collects patient feedback. The goal is to see if the app improves patient engagement and health outcomes.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.
What data supports the effectiveness of the treatment At-home Breast Oncology Care Delivered With E-health Solutions (ABODE Study)?
Research shows that eHealth systems like CHESS have a positive impact on low-income women with breast cancer, improving social support, reducing negative emotions, and enhancing participation in health care. Additionally, mobile applications providing tailored information and support have been shown to improve quality of life and psychological well-being for women undergoing breast cancer treatment.
12345Is the E-Health Solutions for Breast Cancer treatment safe for humans?
The research on E-Health Solutions for Breast Cancer, including web applications and app-based care plans, focuses on improving treatment adherence and managing side effects, but does not provide specific safety data. However, these digital tools are designed to support existing treatments, which have known safety profiles.
678910How is the ABODE Study treatment different from other breast cancer treatments?
The ABODE Study treatment is unique because it uses e-health solutions to provide at-home care for breast cancer patients, offering personalized support and information through a mobile application, which can improve self-management, social support, and quality of life compared to traditional in-person care.
23111213Eligibility Criteria
This trial is for women diagnosed with early-stage breast cancer who need surgery first. They must be over 18, speak English, have internet access and an email. It's not for those with advanced cancer, scheduled immediate surgery, enrolled in similar studies or with sensory challenges.Inclusion Criteria
I am a woman diagnosed with my first invasive breast cancer.
Access to an electronic device with connection to the internet
I can communicate in English and understand the difference between sex and gender.
+3 more
Exclusion Criteria
My breast cancer cannot be removed with surgery.
I have hearing or visual challenges.
My cancer is at stage 4 or has spread to other parts of my body.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive standard care and access to the Breast Cancer Treatment Application (BCTA) for 13 months
13 months
Regular virtual consultations via the app
Follow-up
Participants are monitored for changes in patient activation and other outcomes at 6 and 12 months post-diagnosis
12 months
3 visits (virtual) at baseline, 6 months, and 12 months
Extension
Participants may continue to use the app for ongoing monitoring and support
Optional extension beyond 13 months
Participant Groups
The ABODE study tests a Breast Cancer Treatment App against standard care. The app offers virtual consultations, educational materials, and tracks patient outcomes. The main goal is to see if the app improves patient engagement over a year.
2Treatment groups
Experimental Treatment
Active Control
Group I: Interventional ArmExperimental Treatment1 Intervention
Individuals within the intervention will receive standard care and access to the Breast Cancer Treatment Application (BCTA) for 13 months.
Group II: Control ArmActive Control1 Intervention
The control arm will receive standard treatment.
At-home Breast Oncology Care Delivered With E-health Solutions is already approved in Canada for the following indications:
🇨🇦 Approved in Canada as ABODE Study for:
- Breast cancer management and support
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Tulin CilToronto, Canada
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Who Is Running the Clinical Trial?
University Health Network, TorontoLead Sponsor
References
Oncology nurses' lived experiences of video communication in follow-up care of home-living patients: A phenomenological study in rural Norway. [2021]To explore the lived experiences of oncology nurses (ONs) during three months of virtual care provided through video conferencing (VC) in the follow-up care for home-living patients with cancer in rural Norway.
Use and Impact of eHealth System by Low-income Women With Breast Cancer. [2018]This article is the second of a two-part series reporting on a population-based study intended to use an eHealth system to examine the feasibility of reaching underserved women with breast cancer (Gustafson, McTavish et al., Reducing the digital divide for low-income women with breast cancer, 2004; Madison Center for Health Systems Research and Analysis, University of Wisconsin; Comprehensive Health Enhancement Support System [CHESS]) and determine how they use the system and what impact it had on them. Participants included women recently diagnosed with breast cancer whose income was at or below 250% of poverty level and were living in rural Wisconsin (n = 144; all Caucasian) or Detroit (n = 85; all African American). Because this was a population-based study all 229 participants received CHESS. A comparison group of patients (n = 51) with similar demographics was drawn from a separate recently completed randomized clinical trial. Use rates (e.g., frequency and length of use as well as type of use) as well as impact on several dimensions of quality of life and participation in health care are reported. Low-income subjects in this study logged on and spent more time on CHESS than more affluent women in a previous study. Urban African Americans used information and analysis services more and communication services less than rural Caucasians. When all low-income women from this study are combined and compared with a low-income control group from another study, the CHESS group was superior to that control group in 4 of 8 outcome variables at both statistically and practically significant levels (social support, negative emotions, participation in health care, and information competence). When African Americans and Caucasians are separated the control group's sample size becomes 30 and 21 thus reducing power. Statistical significance is retained, however, in all four outcomes for Caucasians and in two of four for African Americans. Practical significance is retained for all four outcomes. We conclude that an eHealth system like CHESS will be used extensively and have a positive impact on low-income women with breast cancer.
A mobile application of breast cancer e-support program versus routine Care in the treatment of Chinese women with breast cancer undergoing chemotherapy: study protocol for a randomized controlled trial. [2022]Women with breast cancer undergoing chemotherapy suffer from a number of symptoms and report receiving inadequate support from health care professionals. Innovative and easily accessible interventions are lacking. Breast Cancer e-Support is a mobile Application program (App) that provides patients with individually tailored information and a support group of peers and health care professionals. Breast Cancer e-Support aims to promote women's self-efficacy, social support and symptom management, thus improving their quality of life and psychological well-being.
Improving the delivery of team-based survivorship care after primary breast cancer treatment through a multi-level intervention: a pilot randomized controlled trial. [2023]We developed and tested a multi-level intervention, ConnectedCancerCare (CCC), which includes a tailored website and appointment reminder system for women with early-stage breast cancer and a provider summary letter sent to their medical oncologist and primary care provider to improve the delivery of team-based survivorship care.
Effects of Patient-Reported Outcome Tracking and Health Information Provision via Remote Patient Monitoring Software on Patient Outcomes in Oncology Care: A Systematic Review and Meta-Analysis. [2023]The authors sought to 1) review the literature on the remote care model that uses remote patient monitoring software (RPMS) as key mechanisms in oncology care for symptom tracking and health information provision and (2) compare the remote care model to standard care in terms of health-related quality of life, symptom burden, health management self-efficacy, anxiety, and depression.
Impact of web application support versus standard management on adherence with adjuvant hormone therapy in patients treated for breast cancer: the WEBAPPAC study. [2023]Non-metastatic breast cancer treatment is mainly based on surgery, with or without chemotherapy, radiotherapy and/or hormone therapy. To reduce the risk of hormone receptor positive (HR+) disease recurrence, hormone therapy is prescribed for at least 5 years. It may induce adverse drug reactions (ADRs) as joint pain, sexual dysfunction, weight increase, fatigue, mood disorders and vasomotor symptoms. Around 30-40% of patients withhold hormone therapy within 5 years after initiation. Based on encouraging results of mobile health in patient follow-up, we developed a web-application addressed for breast cancer patients initiating adjuvant hormonal therapy and aimed to assess its impact on hormone therapy adherence, ADRs management, and health-related quality of life.
Remote, proactive, telephone based management of toxicity in outpatients during adjuvant or neoadjuvant chemotherapy for early stage breast cancer: pragmatic, cluster randomised trial. [2021]To evaluate the effectiveness of remote proactive management of toxicities during chemotherapy for early stage breast cancer.
Pilot implementation to assess the feasibility and care team impact of an app-based interactive care plan to remotely monitor breast cancer survivors. [2022]To assess the feasibility of an app-based, electronic health record (EHR)-integrated, interactive care plan (ICP) for breast cancer (BC) survivors.
A Web-Based Cancer Self-Management Program (I-Can Manage) Targeting Treatment Toxicities and Health Behaviors: Human-Centered Co-design Approach and Cognitive Think-Aloud Usability Testing. [2023]Patients with cancer require adequate preparation in self-management of treatment toxicities to reduce morbidity that can be achieved through well-designed digital technologies that are developed in co-design with patients and end users.
Improving adherence to endocrine hormonal therapy among breast cancer patients: Study protocol for a randomized controlled trial. [2020]Adjuvant endocrine hormonal therapy (EHT) is highly effective and appropriate for nearly all breast cancer patients with hormone receptor-positive tumors, which represent 75% of all breast cancer diagnoses. Long-term use of EHT reduces recurrence rates and nearly halves the risk of death during the second decade after diagnosis. Despite the proven benefits, about 33% of women receiving EHT do not take their medication as prescribed. This causes an increase in the risk for recurrence and death. To promote adherence to EHT among breast cancer patients, this study will develop and pilot-test an intervention consisting of 1) a bilingual, culturally tailored, personalized, interactive smartphone application (app); and 2) support from a patient navigator. The control group will receive usual care. This 2-group randomized control trial will recruit 120 breast cancer patients receiving EHT at the Mays Cancer Center at UT Health San Antonio. The two-year study will have 3-time assessments (baseline, 3 and 6 months). This theory-based intervention will empower patients' self-monitoring and management. It will facilitate patient education, identification/reporting of side effects, delivery of self-care advice, and simplify communication between the patient and the oncology team. The ultimate goal of this innovative multi-communication intervention is to improve overall survival and life expectancy, enhance quality of life, reduce recurrence, and decrease healthcare cost. The anticipated outcome is a scalable, evidence-based, and easily disseminated intervention with potentially broad use to patients using EHT and other oral anticancer agents.
Electronic Health Interventions for Patients With Breast Cancer: Systematic Review and Meta-Analyses. [2023]Ongoing supportive care using electronic health (eHealth) interventions has the potential to provide remote support and improve health outcomes for patients with breast cancer. This study aimed to evaluate the effectiveness of eHealth interventions on patient-reported outcomes (quality of life [QOL], self-efficacy, and mental or physical health) for patients during and after breast cancer treatment and patient-reported experience measures (acceptability and engagement).
A Nurse-Led mHealth Self-Management Program (mChemotherapy) for Breast Cancer Patients Undergoing Chemotherapy: Study Protocol of a Randomized Controlled Pilot Study. [2022]The global pandemic has caused breast cancer (BC) patients who are receiving chemotherapy to face more challenges in taking care of themselves than usual. A novel nurse-led mHealth program (mChemotherapy) is designed to foster self-management for this population. The aim of the pilot study is to determine the feasibility, usability, and acceptability of an mChemotherapy program for breast cancer patients undergoing chemotherapy. The objective also is to evaluate the preliminary effects of this program on adherence to app usage, self-efficacy, quality of life, symptom burden, and healthcare utilization among this group of patients.
Experiences of Women With Breast Cancer Using Telehealth: A Qualitative Systematic Review. [2023]Breast cancer is the most prevalent malignant neoplasm among women. Its treatment comprises different strategies. Telehealth can ensure continuity of care in distant locations. This study aimed to synthesize qualitative evidence of women's experiences with telehealth during the treatment and follow-up of breast cancer. We performed a qualitative systematic review and meta-synthesis. The databases included in the search were: Pubmed, EMBASE, CINAHAL, and Web of Science. The search combined the terms: breast cancer, telemedicine, telehealth, and qualitative study. The studies included were: qualitative design and mixed methods studies with qualitative components. The COREQ Checklist assisted in assessing the quality of included studies and an adaptation of thematic analysis for the qualitative meta-synthesis. We included twelve articles in the review. In the meta-synthesis, 3 themes emerged. (1) Structure: simple design and space to obtain information but in need of adjustments. (2) Usability: about the benefits and limitations of telehealth. (3) Interaction with health professionals. Telehealth is an accepted strategy for the clinical care of women with breast cancer. Patients identified the need for improvements in structure, usability, and interaction. PROTOCOL REGISTRATION: PROSPERO registration number CRD42021228326, registered 06/02/2021.