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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The Herth Hope Index (HHI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Adapted mindfulness-based stress reduction (Behavioral)
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.
结局指标
主要结局
The Herth Hope Index (HHI)
时间窗: 9 weeks
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.
Depression Anxiety and Stress Scale 21 (DASS-21)
时间窗: 9 weeks
It is a self-reported scale developed by Lovibond, \& Lovibond, (1995). The three subscales of the DASS 21 measure the negative emotional states of depression, anxiety, and stress (i.e., nervous tension and irritability, which are factorially distinct from depression and anxiety). Participants scored questions such as "I thought that as a person I wasn't worth much" (from "0" =did not apply to me at all to "3" =applied very much to me or most of the time). A total score out of 21 was determined for each subscale and then multiplied by 2 to be equivalent to the full-scale DASS scores. At least 10 (depression), 8 (anxiety), and 15 (stress) ratings indicated psychological distress levels for each item. Distress severity was categorized as mild, moderate, severe, and very severe.
Five Factors Mindfulness Questionnaire (FFMQ)
时间窗: 9 weeks
The Baer et al. (2006) scale is a 39-item questionnaire designed to measure different aspects of mindfulness. It uses a five-point Likert scale, with responses ranging from 1 (never or very rarely true) to 5 (very often or always true). The scale consists of five subscales: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Observing subscale: Measures the tendency to notice or attend to internal and external phenomena. Describing subscale: Assesses the ability to label observed phenomena, such as thoughts and emotions. Acting with awareness subscale: Reflects the extent to which individuals engage with full awareness in their current experience or activity. Non-judging subscale: Assesses nonjudgmental awareness of current experience without evaluation. Non-reactivity subscale: Measures the ability to notice internal phenomena without reacting to them.
Change in mindfulness assessed by the Five Facet Mindfulness Questionnaire (FFMQ)
时间窗: Baseline, immediately after the 4-week intervention, and 1 month after intervention completion.
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.
Change in psychological distress assessed by the Depression Anxiety and Stress Scale-21 (DASS-21)
时间窗: Baseline, immediately after the 4-week intervention, and 1 month after intervention completion.
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.
Change in hope assessed by the Herth Hope Index (HHI)
时间窗: Baseline, immediately after the 4-week intervention, and 1 month after intervention completion.
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.
Change in mindfulness assessed by the Five Facet Mindfulness Questionnaire (FFMQ)
时间窗: 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.
Change in psychological distress assessed by the Depression Anxiety and Stress Scale-21 (DASS-21)
时间窗: 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. Each seven-item subscale is multiplied by two, giving a possible score of 0 to 42. The total score ranges from 0 to 126, with higher scores indicating greater psychological distress.
Change in hope assessed by the Herth Hope Index (HHI)
时间窗: 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.
Change in psychological distress assessed by the Depression Anxiety and Stress Scale-21 (DASS-21) total score
时间窗: 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.
次要结局
未报告次要终点
研究者
Heba Mohamed Abdelaal
Principal Investigator
Alexandria University
