Breast Neoplasms
Conditions
Keywords
Breast Cancer Survivors, Slow Jogging, Exercise Therapy, Sleep Quality, Cancer-Related Fatigue, Quality of Life, Randomized Controlled Trial
Brief summary
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.
Detailed description
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. Intervention Participants assigned to the intervention group will receive a standardized 12-week slow jogging exercise program in addition to usual care. Before beginning the intervention, participants will receive face-to-face exercise instruction, an educational manual, demonstration videos, and standardized training to ensure correct performance of the exercise program. Participants will record each exercise session using exercise logs and receive regular reminders and follow-up through the official LINE account to enhance adherence. Participants will perform slow jogging at least three times per week, with each exercise session lasting approximately 36 minutes, according to the prescribed exercise protocol throughout the 12-week intervention period. Participants assigned to the control group will receive routine survivorship care, including standard health education and sleep education provided by the hospital, without participation in the structured slow jogging exercise program during the study period. After completion of the study, participants in the control group will receive the slow jogging educational materials. Outcome Measures The primary outcome is the change in the Chinese Pittsburgh Sleep Quality Index (CPSQI) global score. Secondary outcomes include the change in the Taiwanese Brief Fatigue Inventory (BFI-T) total score and the change in the Functional Assessment of Cancer Therapy-Breast (FACT-B) total score. Outcome assessments will be conducted at baseline and at Weeks 4, 8, and 12. Significance This study is expected to provide high-quality clinical evidence regarding the effectiveness of slow jogging as a supportive care intervention for breast cancer survivors. The findings may contribute to evidence-based exercise recommendations and facilitate the integration of structured exercise programs into routine breast cancer survivorship care, thereby improving sleep quality, reducing cancer-related fatigue, and enhancing health-related quality of life
Interventions
BEHAVIORALSlow Jogging Exercise
Participants assigned to the intervention group will receive a standardized 12-week slow jogging exercise program in addition to usual care. Participants will perform slow jogging at least three times per week, with each session lasting approximately 36 minutes and allowing accumulation in bouts of at least 15 minutes. Before starting the intervention, participants will receive standardized face-to-face instruction, an educational manual, and an exercise demonstration video. The principal investigator will provide practical training, verify participants' exercise technique and safety, and confirm competency before home-based exercise begins. Participants will record each exercise session in an exercise diary and receive regular reminders and follow-up through the official LINE account to promote adherence. Outcome assessments will be conducted at baseline and at weeks 4, 8, and 12.
BEHAVIORALGeneral Health and Sleep Education
Participants assigned to the control group will receive routine health education and sleep education provided by the hospital. Educational messages will be delivered through the official LINE account during the study period. After completion of the study, participants will receive the slow jogging educational materials.
Sponsors
Mackay Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
The statistician responsible for outcome analysis will remain blinded to treatment allocation until completion of the primary analyses.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Female breast cancer survivors aged 20 years or older. 2. Histologically confirmed hormone receptor-positive breast cancer (Stage I-IV) and considered suitable for exercise intervention by the treating physician. 3. 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. 4. Able to independently operate a smartphone and willing to install and use the study application. 5. Self-reported sleep disturbance within the previous two weeks, defined as a Single-item Sleep Quality Scale (SQS) score ≥ 6. 6. Willing to participate and provide written informed consent.
Exclusion criteria
1. History of cancer treatment-related cardiovascular complications or judged by the treating physician to be unsuitable for exercise. 2. Musculoskeletal disorders affecting lower-extremity function (e.g., plantar fasciitis, knee osteoarthritis, ankle degenerative disease) that limit exercise participation. 3. Currently participating in another structured moderate- or vigorous-intensity aerobic exercise program (≥3 sessions/week, ≥30 minutes/session for ≥3 consecutive weeks). 4. Any other medical or psychological condition judged by the investigator to interfere with safe participation or completion of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Quality | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cancer-Related Fatigue | Baseline, Week 4, Week 8, and Week 12 | Cancer-related fatigue will be assessed using the Taiwanese version of the Brief Fatigue Inventory (BFI-T). The BFI-T evaluates fatigue severity and its interference with daily activities. Higher scores indicate greater fatigue. |
| Change in Functional Assessment of Cancer Therapy-Breast (FACT-B) Total Score | Baseline, Week 4, Week 8, and Week 12 | Health-related quality of life will be assessed using the Functional Assessment of Cancer Therapy-Breast (FACT-B). The outcome measure is the change in the FACT-B total score from baseline to Week 12, with additional assessments at Weeks 4 and 8. Higher FACT-B total scores indicate better health-related quality of life. |
Countries
Taiwan
Contacts
CONTACTHsin-Yi Ku, RN, MSN
Outcome results
None listed