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Completed

NCT Number: NCT06025799

Nurse-Delivered Adapted MBSR During Breast Cancer Radiotherapy

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria Ayadi Al Mostakbal Oncology Center

Alexandria, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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.

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

    Time frame: Baseline, 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 6, 2023
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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