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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Adapted mindfulness-based stress reduction

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Egypt
    • Alexandria, Egypt, Egypt
      • Alexandria Ayadi Al Mostakbal Oncology Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adapted mindfulness-based stress reduction plus routine radiotherapy care; 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.	Behavioral: Adapted 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.
No Intervention: Routine-care Arm; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline, immediately after the 4-week intervention, and approximately 1 month after intervention completion.

Collaborators and Investigators

• Sponsor: Alexandria University

Publications and helpful links

General Publications

• Carlson LE, Ursuliak Z, Goodey E, Angen M, Speca M. The effects of a mindfulness meditation-based stress reduction program on mood and symptoms of stress in cancer outpatients: 6-month follow-up. Support Care Cancer. 2001 Mar;9(2):112-23. doi: 10.1007/s005200000206.

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2023
• Primary Completion (Actual): December 6, 2023
• Study Completion (Actual): December 6, 2023

Study Registration Dates

• First Submitted: August 30, 2023
• First Submitted That Met QC Criteria: August 30, 2023
• First Posted (Actual): September 6, 2023

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Breast cancer; Radiotherapy; Psychological Distress; Hope; Mindfulness-based stress reduction; Female patients
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: IRB00013620/8/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No