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Mobile Breast Cancer e-Support Program for Chinese Women With Breast Cancer Undergoing Chemotherapy (Part 2): Multicenter Randomized Controlled Trial.

ABSTRACT: Women undergoing chemotherapy for the treatment of breast cancer have frequently reported unmet supportive care needs. Moreover, easily accessible and innovative support is lacking.The purpose of this trial was to determine the effectiveness of an app-based breast cancer e-support program to address women's self-efficacy (primary outcome), social support, symptom distress, quality of life, anxiety, and depression. Secondary objectives included exploring the association between women's health outcomes and the breast cancer e-support usage data.A multicenter, single-blinded, randomized controlled trial was conducted. A total of 114 women with breast cancer, who were commencing chemotherapy and were able to access internet through a mobile phone, were recruited in the clinics from 2 university-affiliated hospitals in China. Women were randomized either to the intervention group (n=57) receiving breast cancer e-support plus care as usual or the control group (n=57) receiving care as usual alone. The health care team and research assistants collecting data were blinded to the women's group allocation. Bandura's self-efficacy theory and the social exchange theory guided the development of the breast cancer e-support program, which has 4 components: (1) a Learning forum, (2) a Discussion forum, (3) an Ask-the-Expert forum, and (4) a Personal Stories forum. Moderated by an experienced health care professional, the breast cancer e-support program supported women for 12 weeks covering 4 cycles of chemotherapy. Health outcomes were self-assessed through paper questionnaires in clinics at baseline before randomization (T0), after 3 (T1), and 6 months (T2) of follow-ups.Fifty-five participants in the intervention group and 49 in the control group completed the follow-up assessments (response rate: 91.2%). During the 12-week intervention, the log-in frequency ranged from 0 to 774 times (mean 54.7; SD 131.4; median 11; interquartile range, IQR 5-27), and the total usage duration ranged from 0 to 9371 min (mean 1072.3; SD 2359.5; median 100; IQR 27-279). Repeated measures multivariate analysis of covariance (intention-to-treat) found that breast cancer e-support + care as usual participants had significant better health outcomes at 3 months regarding self-efficacy (21.05; 95% CI 1.87-40.22; P=.03; d=0.53), symptom interference (-0.73; 95% CI -1.35 to -.11; P=.02; d=-0.51), and quality of life (6.64; 95% CI 0.77-12.50; P=.03, d=0.46) but not regarding social support, symptom severity, anxiety, and depression compared with care as usual participants. These beneficial effects were not sustained at 6 months. Spearman rank-order correlation showed that the breast cancer e-support usage duration was positively correlated with self-efficacy (r=.290, P=.03), social support (r=.320, P=.02), and quality of life (r=.273, P=.04) at 3 months.The breast cancer e-support program demonstrated its potential as an effective and easily accessible intervention to promote women's self-efficacy, symptom interference, and quality of life during chemotherapy.Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12616000639426; www.ANZCTR.org.au/ACTRN12616000639426.aspx (Archived by Webcite at http://www.webcitation.org/6v1n9hGZq).

SUBMITTER: Zhu J

PROVIDER: S-EPMC5952114 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Mobile Breast Cancer e-Support Program for Chinese Women With Breast Cancer Undergoing Chemotherapy (Part 2): Multicenter Randomized Controlled Trial.

Zhu Jiemin J Ebert Lyn L Liu Xiangyu X Wei Di D Chan Sally Wai-Chi SW

JMIR mHealth and uHealth 20180430 4

<h4>Background</h4>Women undergoing chemotherapy for the treatment of breast cancer have frequently reported unmet supportive care needs. Moreover, easily accessible and innovative support is lacking.<h4>Objective</h4>The purpose of this trial was to determine the effectiveness of an app-based breast cancer e-support program to address women's self-efficacy (primary outcome), social support, symptom distress, quality of life, anxiety, and depression. Secondary objectives included exploring the a ...[more]

PMID: 29712622

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Project description:Chemotherapy (CTX) remains the standard of care for most aggressive tumours, including breast cancer (BC). In BC chemotherapeutic regimens, the maximum tolerated dose of cytotoxic drugs is administered at regular intervals, and cancer cells can re-grow or adapt during the resting periods between cycles. The impact of the tumour microenvironment on the fate of cancer cells after CTX remains poorly understood. Here, we show that paracrine signalling from CTX-treated cancer cells to stromal fibroblasts can drive cancer cell recovery after cytotoxic drug withdrawal. Interferon β1 (IFNβ1) secreted by cancer cells following treatment with high doses of CTX instigates the acquisition of an anti-viral state in stromal fibroblasts. This state is associated with an expression pattern here referred to as interferon signature (IFNS), which encompasses several interferon-stimulated genes (ISGs), including numerous pro-inflammatory cytokine genes. This crosstalk is an important driver of the expansion of BC cells after CTX, and IFNβ1 blockade in tumour cells abrogated their fibroblast-dependent recovery potential. Analysis of human breast carcinomas supported a link between CTX-induced IFNS in tumour stroma and poor response to CTX treatment. First, IFNβ1 expression in human breast carcinomas was found to inversely correlate with recurrence free survival (RFS). Second, using laser capture microdissection data sets, we show a higher expression of IFNS in the stromal tumour compartment compared to the epithelial one and this signature was found to be more prominent in more aggressive subtypes of BC (basal-like), pointing to a pro-tumorigenic role of this signature. Moreover, IFNS was associated with higher recurrence rates and a worse outcome in BC patients. Our study unravels a novel form of paracrine communication between cancer cells and fibroblasts that ultimately results in CTX resistance. Targeting this axis has the potential to improve CTX outcomes in patients with BC.

Project description:PurposeEvaluate the safety and efficacy of efbemalenograstim alfa for neutrophil support in breast cancer patients undergoing myelosuppressive chemotherapy in a phase 2, dose-finding, open-label study (NCT01648322, ClinicalTrials.gov, 2012-07-19).Methods232 patients received up to 4 cycles of chemotherapy, 141 patients with docetaxel + cyclophosphamide (TC) and 91 patients with docetaxel + doxorubicin + cyclophosphamide (TAC). Patients were randomized to efbemalenograstim alfa (80, 240, or 320 µg/kg [TC]; 240 or 320 µg/kg [TAC]) or pegfilgrastim (6 mg) on Day 2 of each cycle.ResultsEfbemalenograstim alfa was non-inferior to pegfilgrastim in duration of moderate and severe neutropenia (absolute neutrophil count [ANC] < 1.0 × 109/L) in TAC Cycle 1 (mean [SD] of 2.1 [1.58] and 2.1 [1.46] days for 240 µg/kg and 320 µg/kg efbemalenograstim alfa, respectively, and 1.8 [1.28] days for pegfilgrastim), with a difference (95% CI) of 0.3 (-0.4, 1.1) days. ANC nadir occurred between Days 7-8 of TAC Cycle 1, with mean [SD] of 0.68 [1.064], 0.86 [1.407] and 0.78[1.283] × 109/L for 240 µg/kg, 320 µg/kg efbemalenograstim alfa and pegfilgrastim, respectively. Time to ANC recovery post nadir (defined as an ANC > 2.0 × 109/L after the expected ANC nadir) was 2.0-2.4 and 1.9 days for TAC patients treated with efbemalenograstim alfa and pegfilgrastim, respectively. No significant difference was found between any dose of efbemalenograstim alfa and pegfilgrastim in TAC Cycle 1 for incidence of moderate to severe neutropenia (76%-77% of patients) or incidence of severe neutropenia (ANC < 0.5 × 109/L; 63%-72%). Efbemalenograstim alfa exhibited similar safety profile to pegfilgrastim. Febrile neutropenia occurred in 4 (1.8%) patients, 2 patients each for 320 µg/kg efbemalenograstim alfa and pegfilgrastim, with no event considered related to study drug.ConclusionEfbemalenograstim alfa was comparable to pegfilgrastim in efficacy and safety.ClinicaltrialsGov identifierNCT01648322.

Project description:BackgroundSince the COVID-19 pandemic, there have been an increasing number of studies on using mobile health (mHealth) to support the symptom self-management of patients with breast cancer (BC). However, the components of such programs remain unexplored. This systematic review aimed to identify the components of existing mHealth app-based interventions for patients with BC who are undergoing chemotherapy and to uncover self-efficacy enhancement elements from among them.MethodsA systematic review was conducted for randomized controlled trials published from 2010 to 2021. Two strategies were used to assess the mHealth apps: The Omaha System, a structured classification system for patient care, and Bandura's self-efficacy theory, which assesses sources of influence that determine an individual's confidence in being able to manage a problem. Intervention components identified in the studies were grouped under the 4 domains of the intervention scheme of the Omaha System. Four hierarchical sources of self-efficacy enhancement elements were extracted from the studies using Bandura's self-efficacy theory.ResultsThe search uncovered 1,668 records. Full-text screening was conducted on 44 articles, and 5 randomized controlled trials (n = 537 participants) were included. Self-monitoring under the domain of "Treatments and procedure" was the most frequently used mHealth intervention for improving symptom self-management in patients with BC undergoing chemotherapy. Most mHealth apps used various "mastery experience" strategies including reminders, self-care advice, videos, and learning forums.ConclusionSelf-monitoring was commonly utilized in mHealth-based interventions for patients with BC undergoing chemotherapy. Our survey uncovered evident variation in strategies to support self-management of symptoms and standardized reporting is required. More evidence is required to make conclusive recommendations related to mHealth tools for BC chemotherapy self-management.

Project description:BackgroundThe 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.MethodsThis is a single-blinded randomized controlled pilot study that includes one intervention group (mChemotherapy group) and one control group (routine care group). Ninety-four breast cancer patients who commence chemotherapy in a university-affiliated hospital will be recruited. Based on the Individual and Family Self-management Theory, this 6-week mChemotherapy program, which includes a combination of self-regulation activities and nurse-led support, will be provided. Data collection will be conducted at baseline, week 3 (T1), and week 6 (T2). A general linear model will be utilized for identifying the between-group, within-group, and interaction effects. Qualitative content analysis will be adopted to analyze, extract, and categorize the interview transcripts.DiscussionsBreast cancer patients receiving chemotherapy are a population that often experiences a heavy symptom burden. During the pandemic, they have had difficulties in self-managing the side effects of chemotherapy due to the lack of face-to-face professional support. An mChemotherapy program will be adopted through a self-regulation process and with the provision of nurse-led real-time professional support for these patients. If proven effective, BC patients who engage in this program will be more likely to take an active role in managing their symptoms, take responsibility for their own health, and subsequently improve their self-efficacy and adherence to the use of the app.

Project description:BackgroundJob loss after a cancer diagnosis can lead to long-term financial toxicity and its attendant adverse clinical consequences, including decreased treatment adherence. Among women undergoing (neo)adjuvant chemotherapy for breast cancer, access to work accommodations (e.g., sick leave) is associated with higher job retention after treatment completion. However, low-income and/or minority women are less likely to have access to work accommodations and, therefore, are at higher risk of job loss. Given the time and transportation barriers that low-income working patients commonly face, it is crucial to develop an intervention that is convenient and easy to use.MethodsWe designed an intervention to promote job retention during and after (neo)adjuvant chemotherapy for breast cancer by improving access to relevant accommodations. Talking to Employers And Medical staff about Work (TEAMWork) is an English/Spanish mobile application (app) that provides (1) suggestions for work accommodations tailored to specific job demands, (2) coaching/strategies for negotiating with an employer, (3) advice for symptom self-management, and (4) tools to improve communication with the medical oncology team. This study is a randomized controlled trial to evaluate the app as a job-retention tool compared to a control condition that provides the app content in an informational paper booklet. The primary outcome of the study is work status after treatment completion. Secondary outcomes include work status 1 and 2 years later, participant self-efficacy to ask an employer for accommodations, receipt of workplace accommodations during and following adjuvant therapy, patient self-efficacy to communicate with the oncology provider, self-reported symptom burden during and following adjuvant therapy, and cancer treatment adherence.DiscussionThis study will assess the use of mobile technology to improve vulnerable breast cancer patients' ability to communicate with their employers and oncology providers, work during treatment and retain their jobs in the long term, thereby diminishing the potential consequences of job loss, including decreased treatment adherence, debt, and bankruptcy.Trial registrationClincalTrials.gov NCT03572374 . Registered on 08 June 2018.

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Dataset Information

Mobile Breast Cancer e-Support Program for Chinese Women With Breast Cancer Undergoing Chemotherapy (Part 2): Multicenter Randomized Controlled Trial.

Publications

Mobile Breast Cancer e-Support Program for Chinese Women With Breast Cancer Undergoing Chemotherapy (Part 2): Multicenter Randomized Controlled Trial.

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