Results of the Optimune trial: A randomized controlled trial evaluating a novel Internet intervention for breast cancer survivors
Open accessAbstract
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 .
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Depression in cancer patients is associated with a higher risk of suicide and systemic inflammation, which may worsen long-term health outcomes.
“Depression, in particular, has been associated with a higher risk of suicide and systemic infammation, which may worsen long-term health outcomes [4,7].”
From Internet‐Based Telecare and Bibliotherapy Delivery of Acceptance and Commitment Therapy for Reducing Anxiety and Depression in Breast Cancer Patients: A Randomized Controlled Trial. (2026) · cites this paper as [7]
The Introduction (page unavailable) says psychological distress in breast cancer survivors—including depression—may be linked to chronic systemic inflammation, which could predict a worse prognosis over time. It does not address suicide risk, and its inflammation statement concerns psychological distress broadly rather than depression specifically. (LLM, conf=0.87)
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- Authors
- Holtdirk, F., Mehnert, A., Weiss, M., Mayer, J., Meyer, B., Bröde, P., Claus, M., & Watzl, C.
- Affiliations
- GAIA (Germany) (DE)
- University Hospital Leipzig (DE)
- TU Dortmund University (DE)
- Corresponding author
- Meyer, Björn
- ORCID
- Venue
- PLOS ONE
- Publisher
- Public Library of Science (PLoS)
- Published
- 2021-05-07
- Volume
- 16
- Issue
- 5
- Pages
- e0251276
- ISSN
- 1932-6203 (ISSN-L)
- PMC
- PMC8104369
- OpenAlex
- W3159954902
- Cited by
- 62
- References
- 81
- Citations by year
- 2026: 4 · 2025: 15 · 2024: 20 · 2023: 14 · 2022: 8 · 2021: 1
- FWCI
- 3.91
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- PLoS ONE (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Informationszentrum Lebenswissenschaften (ZB MED) (submittedVersion, cc-by)
- Funders
- Gaia, Germany
- Topics
- Health Sciences › Medicine › Oncology › Cancer survivorship and care
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Keywords
- breast cancer survivors, online intervention, cognitive behavioral therapy, quality of life, dietary habits, physical activity
- MeSH terms
- Cancer Survivors, Internet-Based Intervention, Adult, Aged, Breast Neoplasms, Diet, Female, Humans, Mental Health, Middle Aged, Quality of Life
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