scholarly journals THRIVE study protocol: a randomized controlled trial evaluating a web-based app and tailored messages to improve adherence to adjuvant endocrine therapy among women with breast cancer

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Andrew J. Paladino ◽  
Janeane N. Anderson ◽  
Rebecca A. Krukowski ◽  
Teresa Waters ◽  
Mehmet Kocak ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Health Outcomes ◽  
Racial Disparities ◽  
Controlled Trial ◽  
Symptom Burden ◽  
Randomized Controlled ◽  
The Impact

Abstract Background Long-term use of adjuvant endocrine therapy (AET) among women with early-stage, hormone receptor-positive breast cancer significantly reduces the risk of hospitalizations, cancer recurrence, and mortality. AET is associated with adverse symptoms that often result in poor adherence. A web-enabled app offers a novel way to communicate and manage symptoms for women on AET. In a region with significant racial disparities in breast cancer outcomes, our study tests the impact of a web-enabled app that collects and transmits patient-reported symptoms to healthcare teams to facilitate timely and responsive symptom management on medication adherence. Methods In this randomized controlled trial, we randomize 300 patients initiating AET to one of three arms: 1) an “App” group (n = 100) that receives weekly reminders to use the THRIVE study app; 2) an “App+Feedback” group (n = 100) that receives weekly reminders and tailored feedback based on their use of the app; or 3) a “Usual Care” group (n = 100) that receives usual care only. Participants are stratified by race: 50% White and 50% Black. The duration of the intervention is six months following enrollment, and outcomes are assessed at 12-months. The primary outcome is adherence, which is captured using an electronic monitoring pillbox. Secondary outcomes include symptom burden, quality of life, self-efficacy for managing symptoms, and healthcare costs. We also evaluate the impact of the intervention on racial disparities in adherence. Data are derived from three sources: electronic health record data to capture treatment changes, healthcare utilization, and health outcomes; self-report survey data related to adherence, symptom burden, and quality of life; and an electronic medication monitoring device that captures adherence. Discussion A successful web-enabled intervention could be disseminated across systems, conditions, and populations. By evaluating the impact of this intervention on a comprehensive set of measures, including AET adherence, patient outcomes, and costs, our study will provide valuable and actionable results for providers, policy makers, and insurers who strive to achieve the “Triple Aim” – reduce costs while improving health outcomes and the patient care experience. Trial registration NCT03592771. Prospectively registered on July 19, 2018.

Telehealth system: A randomized controlled trial evaluating the impact of an internet-based exercise intervention on quality of life, pain, muscle strength, and fatigue in breast cancer survivors

Cancer ◽  
2016 ◽  
Vol 122 (20) ◽  
pp. 3166-3174 ◽  
Author(s):  
Noelia Galiano-Castillo ◽  
Irene Cantarero-Villanueva ◽  
Carolina Fernández-Lao ◽  
Angélica Ariza-García ◽  
Lourdes Díaz-Rodríguez ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Breast Cancer Survivors ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
System A ◽  
The Impact

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

Harnessing Telehealth to Mitigate the Impact of the COVID-19 Pandemic on Sleep and Well-being: A Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Kathleen P. O'Hora ◽  
Raquel A. Osorno ◽  
Dena Sadeghi-Bahmani ◽  
Mateo Lopez ◽  
Allison Morehouse ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Early Treatment ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Randomized Controlled ◽  
The Impact ◽  
Insomnia Symptoms

BACKGROUND The COVID-19 Pandemic led to drastic increases in the prevalence and severity of insomnia symptoms. These increases in insomnia complaints have been paralleled by significant decreases in well-being, including increased symptoms of depression, anxiety, and suicidality and decreased quality of life. However, the efficacy and impact of early treatment of insomnia symptoms on future sleep and well-being remains unknown. OBJECTIVE Here, we present the framework and protocol for a novel study that aims to investigate whether a brief telehealth insomnia intervention targeting new insomnia that developed during the pandemic prevents deterioration of well-being, including symptoms of insomnia, depression, anxiety, suicidality, and quality of life. METHODS The protocol details a two-arm randomized controlled trial to investigate the efficacy of a brief, telehealth-delivered, early treatment of insomnia and evaluate its potential to prevent a deterioration of well-being. Participants with clinically significant insomnia symptoms that began during the pandemic are randomized to either a treatment group or a 28-week waitlist control group. Treatment consists of 4 telehealth sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered over 5 weeks. All participants will complete assessments of insomnia symptom severity, well-being, and daily habits checklist at baseline (week 0), and at weeks 1-6, 12, 28, and 56. RESULTS The trial began enrollment June 3, 2020 and closed enrollment June 17, 2021. As of October 2021, 49 participants have been randomized to either immediate treatment or a 28-week waitlist. 23 participants are still active in the protocol. CONCLUSIONS To our knowledge, this protocol would be represent the first study to test an early sleep intervention for improving insomnia that emerged during the COVID-19 Pandemic. The findings of this study could provide information about the utility of CBT-I for symptoms that emerge in the context of other stressors before they develop a chronic course and deepen understanding of the relationship between sleep and well-being. CLINICALTRIAL NCT04409743

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