Quality of life among women diagnosed with breast Cancer: A randomized waitlist controlled trial of commercially available mobile app-delivered mindfulness training

2018 ◽  
Vol 27 (8) ◽  
pp. 2023-2030 ◽  
Author(s):  
Kristen D. Rosen ◽  
Samantha M. Paniagua ◽  
William Kazanis ◽  
Shaun Jones ◽  
Jennifer Sharpe Potter
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Controlled Trial ◽  
Mobile App ◽  
Mindfulness Training

scholarly journals E-health ecosystem with integrated and stepped psychosocial services for breast cancer survivors: study protocol of a multicentre randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e041548
Author(s):  
Cristian Ochoa-Arnedo ◽  
Joan Carles Medina ◽  
Aida Flix-Valle ◽  
Dimitra Anastasiadou
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Emotional Distress ◽  
Controlled Trial ◽  
Psychosocial Care ◽  
Cost Utility ◽  
Psychosocial Services ◽  
Randomised Controlled

IntroductionPsychosocial interventions for patients with breast cancer (BC) have demonstrated their effectiveness at reducing emotional distress and improving quality of life. The current digitisation of screening, monitoring and psychosocial treatment presents the opportunity for a revolution that could improve the quality of care and reduce its economic burden. The objectives of this study are, first, to assess the effectiveness of an e-health platform with integrated and stepped psychosocial services compared with usual psychosocial care, and second, to examine its cost–utility.Methods and analysisThis study is a multicentre randomised controlled trial with two parallel groups: E-health intervention with integrated and stepped psychosocial services vs usual psychosocial care. An estimated sample of 338 patients with BC in the acute survival phase will be recruited from three university hospitals in Catalonia (Spain) and will be randomly assigned to one of two groups. All participants will be evaluated at the beginning of the study (T1: recruitment), 3 months from T1 (T2), 6 months from T1 (T3) and 12 months from T1 (T4). Primary outcome measures will include number of clinical cases detected, waiting time from detection to psychosocial intervention and proportion of cases successfully treated in the different steps of the intervention, as well as outcomes related to emotional distress, quality of life, post-traumatic stress and growth, treatment adherence and therapeutic alliance. Secondary outcomes will include the acceptability of the platform, patients’ satisfaction and usability. For the cost–utility analysis, we will assess quality-adjusted life years and costs related to healthcare utilisation, medication use and adherence, work absenteeism and infrastructure-related and transport-related costs.Ethics and disseminationThis study was approved by the Ethics committee of the Institut Català d’Oncologia network in Hospitalet, Spain. Findings will be disseminated through peer-reviewed journals, reports to the funding body, conferences among the scientific community, workshops with patients and media press releases.Trial registration numberOnline Psychosocial Cancer Screening, Monitoring and Stepped Treatment in Cancer Survivors (ICOnnectat-B),NCT04372459.

scholarly journals Improving the quality of life of patients with breast cancer-related lymphoedema by lymphaticovenous anastomosis (LVA): study protocol of a multicentre randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e035337 ◽  
Author(s):  
Joost Wolfs ◽  
Jop Beugels ◽  
Merel Kimman ◽  
Andrzej A Piatkowski de Grzymala ◽  
Esther Heuts ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Lymph Node ◽  
Randomised Controlled Trial ◽  
Conservative Treatment ◽  
Cancer Treatment ◽  
Controlled Trial ◽  
Breast Cancer Treatment ◽  
Randomised Controlled

IntroductionEarly breast cancer detection and advancements in treatment options have resulted in an increase of breast cancer survivors. An increasing number of women are living with the long-term effects of breast cancer treatment, making the quality of survivorship an increasingly important goal. Breast cancer-related lymphoedema (BCRL) is one of the most underestimated complications of breast cancer treatment with a reported incidence of 20%. A microsurgical technique called lymphaticovenous anastomosis (LVA) might be a promising treatment modality for patients with BCRL. The main objective is to assess whether LVA is more effective than the current standard therapy (conservative treatment) in terms of improvement in quality of life and weather it is cost-effective.Methods and analysisA multicentre, randomised controlled trial, carried out in two academic and two community hospitals in the Netherlands. The study population includes 120 women over the age of 18 who have undergone treatment for breast cancer including axillary treatment (sentinel lymph node biopsy or axillary lymph node dissection) and/or axillary radiotherapy, presenting with an early stage lymphoedema of the arm, viable lymphatic vessels and received at least 3 months conservative treatment. Sixty participants will undergo the LVA operation and the other sixty will continue their regular conservative treatment, both with a follow-up of 24 months. The primary outcome is the health-related quality of life. Secondary outcomes are societal costs, quality adjusted life years, cost-effectiveness ratio, discontinuation rate of conservative treatment and excess limb volume.Ethics and disseminationThe study was approved by the Ethics Committee of Maastricht University Medical Center (METC) on 19 December 2018 (NL67059.068.18). The results of this study will be disseminated in presentations at academic conferences, publications in peer-reviewed journals and other news media.Trial registration numberNCT02790021; Pre-results.

scholarly journals Randomized Controlled Trial of an Educational Intervention for Managing Fatigue in Women Receiving Adjuvant Chemotherapy for Early-Stage Breast Cancer

2005 ◽  
Vol 23 (25) ◽  
pp. 6027-6036 ◽  
Author(s):  
Patsy Yates ◽  
Sanchia Aranda ◽  
Maryanne Hargraves ◽  
Bev Mirolo ◽  
Alexandra Clavarino ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Functional Assessment ◽  
Controlled Trial ◽  
Intervention Group ◽  
Randomized Controlled ◽  
Cancer Related Fatigue ◽  
Numeric Rating

PurposeTo evaluate the efficacy of a psychoeducational intervention in improving cancer-related fatigue.Patients and MethodsThis randomized controlled trial involved 109 women commencing adjuvant chemotherapy for stage I or II breast cancer in five chemotherapy treatment centers. Intervention group patients received an individualized fatigue education and support program delivered in the clinic and by phone over three 10- to 20-minute sessions 1 week apart. Instruments included a numeric rating scale assessing confidence with managing fatigue; 11-point numeric rating scales measuring fatigue at worst, average, and best; the Functional Assessment of Cancer Therapy–Fatigue and Piper Fatigue Scales; the Cancer Self-Efficacy Scale; the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30; and the Hospital Anxiety and Depression Scale. For each outcome, separate analyses of covariance of change scores between baseline (T1) and the three follow-up time points (T2, T3, and T4) were conducted, controlling for the variable's corresponding baseline value.ResultsCompared with the intervention group, mean difference scores between the baseline (T1) and immediate after the test (T2) assessments increased significantly more for the control group for worst and average fatigue, Functional Assessment of Cancer Therapy–Fatigue, and Piper fatigue severity and interference measures. These differences were not observed between baseline and T3 and T4 assessments. No significant differences were identified for any pre- or post-test change scores for confidence with managing fatigue, cancer self-efficacy, anxiety, depression, or quality of life.ConclusionPreparatory education and support has the potential to assist women to cope with cancer-related fatigue in the short term. However, further research is needed to identify ways to improve the potency and sustainability of psychoeducational interventions for managing cancer-related fatigue.

scholarly journals Effectiveness of peer support on health-related quality of life in recently diagnosed breast cancer patients: a randomized controlled trial

2018 ◽  
Vol 27 (1) ◽  
pp. 123-130 ◽  
Author(s):  
Anu Susanna Toija ◽  
Tarja Helena Kettunen ◽  
Marjut Hannele Kristiina Leidenius ◽  
Tarja Hellin Kaarina Vainiola ◽  
Risto Paavo Antero Roine
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Health Related Quality ◽  
Breast Cancer Patients ◽  
Randomized Controlled ◽  
Related Quality ◽  
Health Related

scholarly journals A Randomized Controlled Trial of the Effects of Transcendental Meditation on Quality of Life in Older Breast Cancer Patients

2009 ◽  
Vol 8 (3) ◽  
pp. 228-234 ◽  
Author(s):  
Sanford I. Nidich ◽  
Jeremy Z. Fields ◽  
Maxwell V. Rainforth ◽  
Rhoda Pomerantz ◽  
David Cella ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Cancer Patients ◽  
Transcendental Meditation ◽  
Controlled Trial ◽  
Breast Cancer Patients ◽  
Randomized Controlled

scholarly journals The prophylactic and therapeutic effects of moxibustion combined with traditional Chinese medicine decoction for treating chemotherapy-induced myelosuppression in early-stage breast cancer: study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Yajie Ji ◽  
Siyu Li ◽  
Xinyue Zhang ◽  
Yu Liu ◽  
Qing Lu ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Chemotherapy Regimen ◽  
Early Stage ◽  
Controlled Trial ◽  
Early Stage Breast Cancer ◽  
Therapeutic Effects ◽  
Breast Cancer Patients ◽  
Randomized Controlled

Abstract Background Traditional Chinese medicine (TCM) has a long history of use in breast cancer, but lacking systematic evidence to support its clinical benefits. In this study, we evaluated the prophylactic and therapeutic effects of moxibustion combined with decoctions for treating chemotherapy-induced myelosuppression (CIM) in early-stage breast cancer patients. Methods This is a randomized controlled clinical trial single-blinded for TCM decoction but not moxibustion. Patients are equally divided into the control group without decoction and moxibustion treatment (control), the decoction+moxibustion group (MD), and the placebo+moxibustion group (MP), according to the following stratification factors: age (below 40s, 40s, 50s, and 60s or above), chemotherapy regimen (anthracyclines, taxanes, anthracyclines+taxane, and others), and chemotherapy strategy (adjuvant and neoadjuvant). The TCM decoction is Wenshen Shengbai Decoction. The anticipated sample size is 462 cases (154 cases in each group). All participants are expected to treat with chemotherapy and recombinant human granulocyte colony-stimulating factor (rhG-CSF). The primary outcomes include the proportion of patients with relief of leukopenia and/or neutropenia, the myelosuppression-associated serious adverse event including grade 3–4 leukopenia and/or neutropenia, and febrile neutropenia, and the dose of rhG-CSF. The secondary outcomes include chemotherapy adherence, stratified analysis, adverse reactions, quality of life by EORTC Breast-Cancer-Specific Quality of Life Questionnaire including EORTC QLQ-C30 (V3.0) and QLQ-BR23, TCM Constitution, and 3-year disease-free survival and overall survival. Baseline information including age, surgical approach, chemotherapy regimen and strategy, pathological stage, and molecular subtype will be recorded. Discussion This will be the first randomized controlled trial to evaluate the efficacy of moxibustion combined with TCM decoction in treating CIM in early-stage breast cancer patients, aiming to standardize the TCM decoction and moxibustion method, thus providing evidence for its clinical benefit. Trial registration chictr.org.cn ChiCTR-INR-16009557. Registered on 23 October 2016.

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