Clinical trial · Interventional
Online Mindfulness-based Stress Reduction for Patients Receiving Chemotherapy
Online Mindfulness-based Stress Reduction Intervention for Patients With Breast Cancer Receiving Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this prospective, waitlist-controlled, 1:1 randomized study is to evaluate if an online mindfulness-based intervention (MBI) reduces treatment-related stress levels among patients with breast cancer receiving chemotherapy. The main questions it aims to answer are: * Does an online MBI intervention reduce stress levels (measured through the Perceived Stress Scale) among participants? * Does an online MBI intervention reduce anxiety, depression, insomnia, fatigue, nausea, diarrhea, constipation, pain, and peripheral neuropathy (measured through the PRO-CTCAE of the National Cancer Institute) among participants? Researchers will compare the online MBI to no intervention to see if online MBI reduces treatment-related stress. Participants will: * Participate in an online MBI or no intervention for 6 weeks * Answer the study surveys at baseline, 7 weeks, and 11 weeks of follow-up
Conditions
Conditions (2)
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 |
| Stress | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Online mindfulness-based stress reduction | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- The intervention group will be assessed with the study surveys at baseline (T1), will participate in the online MBI for the next 6 weeks, and will be subsequently reassessed with the study surveys at 7 weeks (T2) and at 11 weeks (T3) of follow-up.
- interventionNames
- Other: Online mindfulness-based stress reduction
- type
- NO_INTERVENTION
- label
- Wait-list control group
- description
- A wait-list control group will be used with the objective that all participants have the opportunity of receiving the online MBI and at the same time allow comparison of the effectiveness of the program with a group without intervention. Given that treatment-related stress has an important negative impact on patients' wellbeing, it is appropriate to offer the control group the possibility of receiving the intervention if its effectiveness is demonstrated. The control group will be assessed with the study surveys at baseline (T1), will not participate in the online MBI for the next 6 weeks, and will be subsequently reassessed with the study surveys at the same timepoints as the intervention group at 7 weeks (T2) and at 11 weeks (T3) of follow-up. Upon completion of recruitment and follow-up of all participants, the study will end, and the control group will be able to receive the online MBI according to their preference.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female sex * Age ≥18 years * Diagnosis of non-metastatic breast cancer * Treatment with neoadjuvant or adjuvant chemotherapy or plan to start chemotherapy in \<4 weeks * Internet access at home or in their mobile phone * Availability to participate in the online MBI for 6 weeks * Availability to answer the study surveys * Provision of signed informed consent Exclusion Criteria: * Disease recurrence * Current meditation or mindfulness practice * Inability to read or write
References
Publications (0)
Data not yet available