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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06025799
Enrollment
100
Registered
2023-09-06
Start date
2023-09-03
Completion date
2023-12-06
Last updated
2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Mindfulness-based stress reduction, Psychological Distress, Hope, Female patients, Radiotherapy, Breast cancer

Brief summary

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.

Detailed description

Women receiving care at the oncology centre were initially identified through a review of clinical records. Those who appeared to meet the study requirements were invited for direct verification of all eligibility criteria. Written consent was obtained before baseline assessment, group allocation, and delivery of any study intervention.

Interventions

BEHAVIORALAdapted mindfulness-based stress reduction

Adapted mindfulness-based stress reduction The behavioural programme combined breathing focused attention, body-awareness exercises, seated meditation, gentle mindful movement, education about stress responses, group reflection, and guided practice outside the sessions. Both facilitators followed the same delivery guide and used uniform materials.A researcher who did not deliver the intervention observed implementation using a structured fidelity checklist.

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in mindfulness assessed by the Five Facet Mindfulness Questionnaire (FFMQ)Baseline, immediately after the 4-week intervention, and approximately 1 month after intervention completion.The FFMQ is a 39-item self-report measure covering observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity. Items are rated from 1 to 5. The total score ranges from 39 to 195, with higher scores reflecting greater mindfulness.
Change in psychological distress assessed by the Depression Anxiety and Stress Scale-21 (DASS-21) total scoreBaseline, immediately after the 4-week intervention, and approximately 1 month after intervention completion.The DASS-21 contains 21 self-report items divided into depression, anxiety, and stress subscales. Items are rated from 0 to 3. The seven items within each subscale are summed and multiplied by two, producing depression, anxiety, and stress scores ranging from 0 to 42. The overall psychological-distress score is calculated as the sum of the three scaled subscale scores and ranges from 0 to 126. Higher scores indicate greater psychological distress.
Change in hope assessed by the Herth Hope Index (HHI)Baseline, immediately after the 4-week intervention, and approximately 1 month after intervention completion.The HHI is a 12-item self-report measure of hope. Items are rated on a four-point scale from 1 to 4. Items 3 and 6 are reverse scored before calculation of the total score. Total scores range from 12 to 48, with higher scores indicating greater hope. The measure includes temporality and future, positive readiness and expectancy, and interconnectedness.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 17, 2026