Clinical trial · Interventional
Evaluating a Novel Web-based Intervention for Breast Cancer Survivors
Evaluation of a Web-based Psychological Intervention as add-on to Care as Usual in Breast Cancer Survivors: Effect on Immune Status, Inflammation and Psychometric Outcome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Participant recruitment was stopped due to corona pandemic.
Summary
Brief summary (as posted)
The trial aims to evaluate the effectiveness of a novel web-based intervention (Optimune), which was designed to introduce relevant cognitive-behavioral therapy (CBT) techniques to women with breast cancer who are past the active eradication phase and free from disease recurrence. The present study will test the hypothesis that Optimune has an impact on immune status, markers of inflammation and psychometric outcomes. Therefore, 150 woman with breast cancer will be recruited and randomized to two groups: (1) a control group, in which they may engage with any treatment (Care-as-Usual, CAU) and receive access to Optimune after a delay of 6 months (i.e., CAU/wait list control group), or (2) to a treatment group that immediately receives 12-month access to Optimune and may also use CAU. The primary outcome measure is the effect on inflammatory parameters six month post-baseline.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Care-As-Usual | Other | — | UNRESOLVED |
| Optimune | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Optimune
- description
- Optimune is an web-based psychological intervention for women with breast cancer. Beyond established CBT techniques targeting depression, anxiety, and fatigue, this intervention specifically includes elements that have shown effects on markers of immune status and inflammation, including sleep, stress management (e.g., mindfulness-based techniques) and lifestyle optimization (dietary and physical activity advice). Content is continuously adapted to users' concerns and needs. It contains interactive dialogues that can be accessed via computer or smart-phone, illustrations, audio files and motivating text messages. Optional daily text messages with motivational content accompany the program. The program can be accessed for 365 days after registration.
- interventionNames
- Behavioral: Optimune
- type
- ACTIVE_COMPARATOR
- label
- Care-as-Usual
- description
- As in the experimental arm, participants are free to continue to engage with any treatment they require (i.e., CAU). However, they will receive access to Optimune six months post-baseline (i.e., wait list with respect to Optimune access).
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: Eligible are women who * had breast cancer diagnosed less than 4 years ago, classified as T0-4, N0-1, M0 * completed acute treatment for breast cancer at least 6 month ago. This applies for surgery, chemotherapy or radiation, whichever occurred last. (Prophylactic treatment with anti-hormones like tamoxifen, aromatase-inhibitors or bisphosphonates is allowed). * are competent in German language * provide written consent to study procedures * are willing to provide the discharge letter from oncology (to verify diagnosis and therapies) Exclusion Criteria: Women are not eligible if they * have a prior history of breast cancer (other than the current one) or any other cancer except basal or squamous cell skin cancer * suffer from the following autoimmune and/or inflammatory diseases: rheumatoid arthritis, lupus erythematodes, psoriasis, multiple sclerosis or inflammatory breast cancer * have a history of schizophrenia, bipolar disorder, or an established diagnosis of borderline personality disorder * have elevated current suicide risk * routinely attend psychotherapy, either 1:1, group-therapy or web-based interaction (at least two sessions per month) * practice 5 hours or more of vigorous physical activity per week (e.g. training for marathon) * have cognitive impairment * abuse alcohol or drugs
References
Publications (0)
Data not yet available