scholarly journals Results of the Optimune trial: A randomized controlled trial evaluating a novel Internet intervention for breast cancer survivors

PLoS ONE ◽  
2021 ◽  
Vol 16 (5) ◽  
pp. e0251276
Author(s):  
Franziska Holtdirk ◽  
Anja Mehnert ◽  
Mario Weiss ◽  
Johannes Mayer ◽  
Björn Meyer ◽  
...  

Introduction After the acute treatment phase, breast cancer patients often experience low quality of life and impaired mental health, which could potentially be improved by offering cognitive behavioural therapy (CBT) and addressing exercise and dietary habits. However, CBT and other behavioural interventions are rarely available beyond the acute treatment phase. Internet-based interventions could bridge such treatment gaps, given their flexibility and scalability. In this randomized controlled trial (RCT), we investigated the effects of such an intervention (“Optimune”) over three months. Methods This RCT included 363 female breast cancer survivors (age range = 30–70), recruited from the community, who had completed the active treatment phase. Inclusion criteria were: breast cancer diagnosis less than 5 years ago and acute treatment completion at least 1 month ago. Participants were randomly assigned to (1) an intervention group (n = 181), in which they received care as usual (CAU) plus 12-month access to Optimune immediately after randomization, or (2) a control group (n = 182), in which they received CAU and Optimune after a delay of 3 months. Primary endpoints were quality of life (QoL), physical activity, and dietary habits at three months. We hypothesized that intervention group participants would report better QoL, more physical activity, and improved dietary habits after 3 months. Results Intention-to-treat (ITT) analyses revealed significant effects on QoL (d = 0.27, 95% CI: 0.07–0.48) and dietary habits (d = 0.36, 95% CI: 0.15–0.56), but the effect on physical exercise was not significant (d = 0.30; 95% CI: 0.10–0.51). Discussion These findings suggest the effectiveness of Optimune, a new CBT-based Internet intervention for breast cancer survivors, in facilitating improvements in quality of life and dietary habits. Efforts to disseminate this intervention more broadly may be warranted. Trial registration ClinicalTrials.gov, NCT03643640. Registered August 23rd 2018, https://clinicaltrials.gov/ct2/show/NCT03643640.

2020 ◽  
Vol 19 ◽  
pp. 153473542092475
Author(s):  
Julia Ruiz-Vozmediano ◽  
Sarah Löhnchen ◽  
Lucas Jurado ◽  
Rosario Recio ◽  
Andrea Rodríguez-Carrillo ◽  
...  

Background: Integrative oncology has proven to be a useful approach to control cancer symptoms and improve the quality of life (QoL) and overall health of patients, delivering integrated patient care at both physical and emotional levels. The objective of this randomized trial was to evaluate the effects of a triple intervention program on the QoL and lifestyle of women with breast cancer. Methods: Seventy-five survivors of stage IIA-IIB breast cancer were randomized into 2 groups. The intervention group (IG) received a 6-month dietary, exercise, and mindfulness program that was not offered to the control group (CG). Data were gathered at baseline and at 6 months postintervention on QoL and adherence to Mediterranean diet using clinical markers and validated questionnaires. Between-group differences at baseline and 3 months postintervention were analyzed using Student’s t test for related samples and the Wilcoxon and Mann-Whitney U tests. Results: At 6 months postintervention, the IG showed significant improvements versus CG in physical functioning ( p = .027), role functioning ( p = .028), and Mediterranean diet adherence ( p = .02) and a significant reduction in body mass index ( p = .04) and weight ( p = .05), with a mean weight loss of 0.7 kg versus a gain of 0.55 kg by the CG ( p = .05). Dyspnea symptoms were also increased in the CG versus IG ( p = .066). Conclusions: These results demonstrate that an integrative dietary, physical activity, and mindfulness program enhances the QoL and healthy lifestyle of stage IIA-IIB breast cancer survivors. Cancer symptoms may be better managed by the implementation of multimodal rather than isolated interventions.


2020 ◽  
Vol 9 (21) ◽  
pp. 7837-7848
Author(s):  
Amelie G. Ramirez ◽  
Edgar Muñoz ◽  
Dorothy Long Parma ◽  
Arely Perez ◽  
Alfredo Santillan

2018 ◽  
Vol 28 (2) ◽  
pp. e12961
Author(s):  
Chai Hong Rim ◽  
Sung-Ja Ahn ◽  
Jin Hee Kim ◽  
Won Sup Yoon ◽  
Mison Chun ◽  
...  

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e036864
Author(s):  
Courtney J Stevens ◽  
Mark T Hegel ◽  
Marie Anne Bakitas ◽  
Martha Bruce ◽  
Andres Azuero ◽  
...  

IntroductionMany breast cancer survivors report an inability to fully participate in activities of daily living after completing cancer treatment. Reduced activity participation is linked to negative consequences for individuals (eg, depression, reduced quality of life) and society (reduced workforce participation). There is currently a lack of evidence-based interventions that directly foster cancer survivors’ optimal participation in life roles and activities. Pilot study data suggest rehabilitation interventions based on behavioural activation (BA) and problem-solving treatment (PST) can facilitate post-treatment role resumption among breast cancer survivors.Methods and analysisThis protocol describes a multisite randomised controlled trial comparing a 4-month long, nine-session BA and PST-informed rehabilitation intervention (BA/PS) against a time-matched, attention control condition. The overall objective is to assess the efficacy of BA/PS for enhancing breast cancer survivors’ activity participation and quality of life over time. A total of 300 breast cancer survivors reporting participation restrictions after completing curative treatment for stage 1–3 breast cancer within the past year will be recruited across two sites (Dartmouth-Hitchcock Medical Center and University of Alabama at Birmingham). Assessments are collected on enrolment (T1) and 8 (T2), 20 (T3) and 44 (T4) weeks later.Ethics and disseminationStudy procedures are approved by the Committee for the Protection of Human Subjects at Dartmouth College, acting as the single Institutional Review Board of record for both study sites (STUDY 00031380). Results of the study will be presented at national meetings and submitted for publication in peer-reviewed journals.Trial registration numberNCT03915548; Pre-results.


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