Slow Jogging for Breast Cancer Survivors

NCT07757763 | Recruiting

• 1 other identifier: 25MMHIS391e
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Keywords

Breast Cancer Survivors; Slow Jogging; Exercise Therapy; Sleep Quality; Cancer-Related Fatigue; Quality of Life; Randomized Controlled Trial

Outcome Measures

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.

  Baseline, Week 4, Week 8, and Week 12

Secondary Outcomes (2)

• 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

Study Arms (2)

Slow Jogging Exercise Group

EXPERIMENTAL

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.

Behavioral: Slow Jogging Exercise

Usual Care Group

ACTIVE COMPARATOR

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.

Behavioral: General Health and Sleep Education

Interventions

Slow Jogging Exercise BEHAVIORAL

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.

Slow Jogging Exercise Group

General Health and Sleep Education BEHAVIORAL

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.

Usual Care Group

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mackay Memorial Hospital: lead

Study Sites (1)

Taipei Mackay Memorial Hospital

Taipei, Taipei City, 10449, Taiwan

RECRUITING

Related Publications (4)

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

  RESULT

• 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.

  PMID: 21924421 RESULT

• 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.

  PMID: 17377841 RESULT

• 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.

  PMID: 16155782 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Sleep Initiation and Maintenance Disorders

Interventions

Health Status

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health

Central Study Contacts

Hsin-Yi Ku, RN, MSN

CONTACT

+886-2-2543-3535; shinyi.6178@mmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician responsible for outcome analysis will remain blinded to treatment allocation until completion of the primary analyses.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 11, 2026
• Study Start: April 14, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)