Nurse-Delivered Adapted MBSR During Breast Cancer Radiotherapy

NCT06025799 | Completed

• 1 other identifier: IRB00013620/8/2023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

Adapted mindfulness-based stress reduction plus routine radiotherapy care

EXPERIMENTAL

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

Routine-care Arm

NO INTERVENTION

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.

Interventions

Adapted mindfulness-based stress reduction BEHAVIORAL

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.

Adapted mindfulness-based stress reduction plus routine radiotherapy care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria Ayadi Al Mostakbal Oncology Center

Alexandria, Egypt, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 6, 2023
• Study Start: September 3, 2023
• Primary Completion: December 6, 2023
• Study Completion: December 6, 2023
• Last Updated: July 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)