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This trial evaluated whether an adapted nurse-delivered mindfulness-based stress reduction program could support women receiving radiotherapy after breast cancer surgery. Participants were assigned to either routine radiotherapy care alone or routine care plus the adapted mindfulness program. The intervention included eight face-to-face sessions delivered over four weeks, together with guided home mindfulness practice. Psychological distress, hope, and mindfulness were measured before the intervention, immediately after the four-week program, and one month after intervention completion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adapted mindfulness-based stress reduction plus routine radiotherapy care | Experimental | Participants assigned to this arm received routine radiotherapy care in addition to an adapted mindfulness-based stress reduction program delivered over four weeks consisting of eight structured face-to-face sessions with guided home mindfulness practice. The program included breathing awareness, body scan, sitting meditation, mindful movement, stress education, and group discussion. |
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| Routine radiotherapy care | No Intervention | Participants in this arm received the oncology center's usual radiotherapy-related care, routine nursing care, medical follow-up, and available supportive or referral services according to standard practice. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapted mindfulness-based stress reduction | Behavioral | An adapted mindfulness-based stress reduction program delivered over four weeks consisting of eight structured sessions including breathing awareness, body scan, sitting meditation, mindful movement, stress education, group discussion, and guided home practice. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mindfulness assessed by the Five Facet Mindfulness Questionnaire (FFMQ) | The Five Facet Mindfulness Questionnaire is a 39-item self-report instrument assessing five dimensions of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Items are rated on a 5-point Likert scale ranging from 1 (never or very rarely true) to 5 (very often or always true). Higher scores indicate greater mindfulness. Scores were assessed at baseline, immediately after the 4-week intervention, and 1 month after intervention completion. | Baseline, immediately after the 4-week intervention, and 1 month after intervention completion. |
| Change in psychological distress assessed by the Depression Anxiety and Stress Scale-21 (DASS-21) | The Depression Anxiety and Stress Scale-21 (DASS-21), developed by Lovibond and Lovibond (1995), is a 21-item self-report instrument comprising three 7-item subscales assessing depression, anxiety, and stress. Each item is rated from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). Scores for each subscale range from 0 to 21 and are multiplied by 2 to correspond to the full 42-item DASS scoring system, producing a score range of 0 to 42 for each subscale. Higher scores indicate greater symptom severity. | Baseline, immediately after the 4-week intervention, and 1 month after intervention completion. |
| Change in hope assessed by the Herth Hope Index (HHI) | The Herth Hope Index (HHI) is a clinical-setting adaptation form of the Herth Hope Scale (HHS). This scale was developed by Herth, at Minnesota State in the USA (Herth, 1992). It is composed of 12 items, which are rated on a four points Likert scale. The responses ranged from 1 (strongly disagree) to 4 (strongly agree). Items 3 and 6 are reversed in their score. The twelve items are summed to obtain a total score that ranges from 12 to 48, with a higher score equating to a higher level of hope. The instrument contains three factors, namely temporality & future, positive readiness & expectancy, and finally interconnectedness with self and others. | Baseline, immediately after the 4-week intervention, and 1 month after intervention completion. |
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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.
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.
The study was limited to adult women receiving post-mastectomy radiotherapy for breast cancer to maintain a clinically homogeneous sample and reduce treatment-related confounding.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria Ayadi Al Mostakbal Oncology Center | Alexandria | Egypt | Egypt |
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|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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