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Breast NeoplasmsSJBCNCT07757763

Slow Jogging for Breast Cancer Survivors

A study testing Slow Jogging Exercise and General Health and Sleep Education in people with Breast Neoplasms, run by Mackay Memorial Hospital at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Breast cancer survivors frequently experience persistent sleep disturbance, cancer-related fatigue, and reduced health-related quality of life after completion of primary treatment. Read more about this study

Who is it for?
Ages 20 years and older, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
Slow Jogging Exercise and General Health and Sleep Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
1 siteTaiwan
Study dates
14 Apr 2026to 31 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Taiwan1 site, 1 recruiting
  • Taipei Mackay Memorial Hospital

    Taipei, Taipei City, 10449

    Recruiting

Other trials in Taiwan

About this study

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

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.

Read the 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

Being tested
Slow Jogging Exercise, General Health and Sleep Education
Keywords
Breast Cancer Survivors, Slow Jogging, Exercise Therapy, Sleep Quality, Cancer-Related Fatigue, Quality of Life, Randomized Controlled Trial
Medical subject headings
Breast Neoplasms, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Slow Jogging ExerciseBehavioural

    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.

  • General Health and Sleep EducationBehavioural

    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.

Study groups in NCT07757763
Study groupRoleWhat they receive
Slow Jogging Exercise GroupExperimentalParticipants 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.
Receives: Behavioral: Slow Jogging Exercise
Usual Care GroupActive comparatorParticipants 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.
Receives: Behavioral: General Health and Sleep Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Week 4, Week 8, and Week 12

Secondary outcomes (2)
  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.

    Measured: Baseline, Week 4, Week 8, and Week 12

  2. 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.

    Measured: Baseline, Week 4, Week 8, and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2026
  2. Study start14 Apr 2026
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
104 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07757763
Sponsor's protocol ID
25MMHIS391e
Acronym
SJBC
Status last verified
Aug 2026
First submitted
6 Aug 2026
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tanaka, H., & Jackowska, M. (2019). Slow jogging a multi dimensional approach to physical activity in the health convention. Journal of Kinesiology

  • Tzeng JI, Fu YW, Lin CC. Validity and reliability of the Taiwanese version of the Pittsburgh Sleep Quality Index in cancer patients. Int J Nurs Stud. 2012 Jan;49(1):102-8. doi: 10.1016/j.ijnurstu.2011.08.004. Epub 2011 Sep 14.

    PubMed 21924421
  • Wan C, Zhang D, Yang Z, Tu X, Tang W, Feng C, Wang H, Tang X. Validation of the simplified Chinese version of the FACT-B for measuring quality of life for patients with breast cancer. Breast Cancer Res Treat. 2007 Dec;106(3):413-8. doi: 10.1007/s10549-007-9511-1. Epub 2007 Mar 22.

    PubMed 17377841
  • Tsai PS, Wang SY, Wang MY, Su CT, Yang TT, Huang CJ, Fang SC. Psychometric evaluation of the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI) in primary insomnia and control subjects. Qual Life Res. 2005 Oct;14(8):1943-52. doi: 10.1007/s11136-005-4346-x.

    PubMed 16155782

Questions about this trial

What is this clinical trial studying?

A study testing Slow Jogging Exercise and General Health and Sleep Education in people with Breast Neoplasms, run by Mackay Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hsin-Yi Ku, RN, MSN (+886-2-2543-3535 ext. 3991, shinyi.6178@mmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep Quality (time frame: Baseline, Week 4, Week 8, and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07757763, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.

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