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The Effectiveness of Slow Jogging on Sleep, Fatigue, and Quality of Life in Breast Cancer Survivors

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 20
Healthy Volunteers: f
View:

• 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 ≥ 6.

• Willing to participate and provide written informed consent.

Locations
Other Locations
Taiwan
Taipei Mackay Memorial Hospital
RECRUITING
Taipei
Contact Information
Primary
Hsin-Yi Ku, RN, MSN
shinyi.6178@mmh.org.tw
+886-2-2543-3535
Time Frame
Start Date: 2026-04-14
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 104
Treatments
Experimental: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Mackay Memorial Hospital

This content was sourced from clinicaltrials.gov

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