Clinical trial · Interventional
Nurse-Delivered Adapted MBSR During Breast Cancer Radiotherapy
Effects of a Nurse-Delivered, Adapted Mindfulness-Based Stress Reduction Intervention on Psychological Distress, Hope, and Mindfulness in Women With Breast Cancer Receiving Radiotherapy: A Randomized Controlled Trial
- 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)
This randomized study examined whether adding a condensed mindfulness programme to standard radiotherapy care could improve psychosocial outcomes among women treated for breast cancer. One hundred participants were assigned to routine care alone or routine care together with the nurse-facilitated programme. Emotional distress, hope, and mindfulness were evaluated before the programme, directly after its completion, and approximately one month later.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adapted mindfulness-based stress reduction | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Adapted mindfulness-based stress reduction plus routine radiotherapy care
- description
- Adapted mindfulness-based stress reduction plus routine radiotherapy care Participants continued to receive the centre's standard radiotherapy-related services and also attended a four-week mindfulness programme facilitated jointly by two trained nurses. The programme included eight structured group meetings and a practice-consolidation day. Common facilitator guidance, participant materials, and audio resources were used throughout. Between-session practice was supported through scheduled telephone contact and WhatsApp communication, and missed meetings were rescheduled.
- interventionNames
- Behavioral: Adapted mindfulness-based stress reduction
- type
- NO_INTERVENTION
- label
- Routine-care Arm
- description
- Routine-care Arm Participants assigned to the comparison arm continued with the oncology centre's established radiotherapy pathway, including routine nursing care, medical review, symptom monitoring, and access to available supportive or referral services. After completion of the final study assessment, the mindfulness programme was offered to those who wished to receive it.
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Adult women with non-metastatic breast cancer who were receiving post-mastectomy radiotherapy were eligible. Participants had to be within one to six months after mastectomy, able to read and write, able to communicate verbally, available for follow-up, and willing to provide informed consent and undergo randomization. Ability to read and write was required because participants completed self-administered outcome questionnaires and used written intervention materials, home-practice instructions, and weekly practice diaries. Exclusion Criteria: Participants were excluded if they had metastatic disease, current alcohol or drug misuse, serious comorbid conditions such as renal, cardiac, or liver disease, or any condition that limited their ability to complete the study procedures or outcome assessments.
References
Publications (0)
Data not yet available