Nurse-Delivered Adapted MBSR During Breast Cancer Radiotherapy

Alexandria University100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

100

Conditions

Breast Cancer

Interventions

Adapted mindfulness-based stress reductionBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Alexandria Ayadi Al Mostakbal Oncology Center

Alexandria, Egypt, Egypt

Outcomes

Primary Outcomes

Change in mindfulness assessed by the Five Facet Mindfulness Questionnaire (FFMQ)

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.

Time frame: Baseline, immediately after the 4-week intervention, and approximately 1 month after intervention completion.

Change in psychological distress assessed by the Depression Anxiety and Stress Scale-21 (DASS-21) total score

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.

Time frame: Baseline, immediately after the 4-week intervention, and approximately 1 month after intervention completion.

Change in hope assessed by the Herth Hope Index (HHI)

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.

Time frame: Baseline, immediately after the 4-week intervention, and approximately 1 month after intervention completion.

Data from ClinicalTrials.gov

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