The Effectiveness of Slow Jogging on Sleep, Fatigue, and Quality of Life in Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Sleep Quality
研究概览
简要总结
Breast cancer survivors frequently experience persistent sleep disturbance, cancer-related fatigue, and reduced health-related quality of life after completion of primary treatment. Although exercise is recommended as an important component of survivorship care, evidence regarding the effectiveness of slow jogging remains limited. This investigator-initiated, single-center, parallel-group randomized controlled trial aims to evaluate the effectiveness of a standardized 12-week slow jogging exercise program in women aged 20 years or older with hormone receptor-positive Stage I-IV breast cancer who have completed primary cancer treatment within the previous 12 months. Participants will be randomized using permuted block randomization (block size = 6) to receive either a slow jogging intervention plus usual care or usual care alone. The primary outcome is sleep quality measured by the Chinese Pittsburgh Sleep Quality Index (CPSQI). Secondary outcomes include cancer-related fatigue measured by the Taiwanese Brief Fatigue Inventory (BFI-T) and health-related quality of life measured by the Functional Assessment of Cancer Therapy-Breast (FACT-B). Outcomes will be assessed at baseline and at Weeks 4, 8, and 12.
详细描述
Background Breast cancer is the most common malignancy among women worldwide. Although advances in cancer treatment have substantially improved survival rates, many breast cancer survivors continue to experience persistent sleep disturbance, cancer-related fatigue, and impaired health-related quality of life after completing primary treatment. Exercise is recognized as an important component of cancer survivorship care; however, evidence regarding the effectiveness of slow jogging for improving these outcomes among breast cancer survivors remains limited. Slow jogging is a low-impact aerobic exercise performed at a comfortable pace and is considered safe and feasible for individuals with different levels of physical fitness. This study aims to evaluate the effectiveness of a structured slow jogging exercise program in improving sleep quality, reducing cancer-related fatigue, and enhancing health-related quality of life among breast cancer survivors.
Study Design
This is an investigator-initiated, single-center, parallel-group randomized controlled trial conducted at Mackay Memorial Hospital, Taiwan.
Eligible participants are women aged 20 years or older with histologically confirmed hormone receptor-positive breast cancer (Stage I-IV) who have completed primary cancer treatment (surgery, chemotherapy, or radiotherapy) within the previous 12 months. Participants receiving ongoing anti-human epidermal growth factor receptor 2 (HER2) targeted therapy and/or endocrine therapy are eligible. Additional eligibility criteria include the ability to independently operate a smartphone, willingness to use the study LINE official account, and self-reported sleep disturbance within the previous two weeks, defined as a Single-item Sleep Quality Scale (SQS) score of 6 or higher.
Participants will be randomly assigned to either the slow jogging intervention group or the usual care control group using permuted block randomization (block size = 6) with allocation concealment to ensure balanced group assignment throughout participant enrollment.
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)
盲法说明
The statistician responsible for outcome analysis will remain blinded to treatment allocation until completion of the primary analyses.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female breast cancer survivors aged 20 years or older.
- •Histologically confirmed hormone receptor-positive breast cancer (Stage I-IV) and considered suitable for exercise intervention by the treating physician.
- •Completed primary cancer treatment (surgery, chemotherapy, or radiotherapy) within the previous 12 months; participants receiving ongoing anti-HER2 targeted therapy and/or endocrine therapy are eligible.
- •Able to independently operate a smartphone and willing to install and use the study application.
- •Self-reported sleep disturbance within the previous two weeks, defined as a Single-item Sleep Quality Scale (SQS) score ≥
- •Willing to participate and provide written informed consent.
排除标准
- •History of cancer treatment-related cardiovascular complications or judged by the treating physician to be unsuitable for exercise.
- •Musculoskeletal disorders affecting lower-extremity function (e.g., plantar fasciitis, knee osteoarthritis, ankle degenerative disease) that limit exercise participation.
- •Currently participating in another structured moderate- or vigorous-intensity aerobic exercise program (≥3 sessions/week, ≥30 minutes/session for ≥3 consecutive weeks).
- •Any other medical or psychological condition judged by the investigator to interfere with safe participation or completion of the study.
研究组 & 干预措施
Slow Jogging Exercise Group
Participants assigned to this arm will receive a standardized 12-week slow jogging exercise program in addition to usual care. The intervention includes slow jogging at least three times per week, standardized exercise instruction, an educational manual, an exercise demonstration video, exercise logs, and regular follow-up through the official LINE account to promote adherence. Outcome assessments will be conducted at baseline and at weeks 4, 8, and 12.
干预措施: Slow Jogging Exercise (Behavioral)
Usual Care Group
Participants assigned to this arm will receive usual care, including routine health education and sleep education provided by the hospital. Educational materials and follow-up will be delivered according to standard clinical practice. After completion of the study, participants will receive the slow jogging educational materials.
干预措施: General Health and Sleep Education (Behavioral)
结局指标
主要结局
Sleep Quality
时间窗: Baseline, Week 4, Week 8, and Week 12
Sleep quality will be assessed using the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI). The CPSQI consists of 19 self-reported items and generates a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality.
次要结局
- Cancer-Related Fatigue(Baseline, Week 4, Week 8, and Week 12)
- Change in Functional Assessment of Cancer Therapy-Breast (FACT-B) Total Score(Baseline, Week 4, Week 8, and Week 12)