Slow Jogging for Breast Cancer Survivors
ConditionBreast Neoplasms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20+
SponsorMackay Memorial Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Slow Jogging Exercise
BehavioralParticipants 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.
General Health and Sleep Education
BehavioralParticipants 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.
Treatment groups
104 Participants
are divided into 2 treatment groupsGroup A: Slow Jogging Exercise GroupExperimental treatment 1 intervention
Group B: Usual Care GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Sleep Quality
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.
Time frame
Baseline, Week 4, Week 8, and Week 12Secondary outcomes
1
Cancer-Related Fatigue
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.
Time frame
Baseline, Week 4, Week 8, and Week 122
Change in Functional Assessment of Cancer Therapy-Breast (FACT-B) Total Score
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.
Time frame
Baseline, Week 4, Week 8, and Week 12Sponsors and contacts
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Source ClinicalTrials.gov