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Development and efficacy of an exercise adherence program for breast cancer survivors with fatigue, and its efficacy on fatigue, quality of life, and adherence to exercise

Status Approved

  • First Submitted Date

    2020/12/31

  • Registered Date

    2021/01/11

  • Last Updated Date

    2020/12/31

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0005763
    Unique Protocol ID 4-2017-0164
    Public/Brief Title Efficacy of an exercise adherence RCT for breast cancer survivors with fatigue
    Scientific Title Development and efficacy of an exercise adherence program for breast cancer survivors with fatigue, and its efficacy on fatigue, quality of life, and adherence to exercise
    Acronym BLESS
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 4-2017-0164
    Approval Date 2017-04-19
    Institutional Review Board Name Yonsei University Health System, Severance Hospital, Institutional Review Board
    Institutional Review Board Address 50-1, Yonsei-ro, Seodaemun-gu, Seoul
    Institutional Review Board Telephone 02-2228-0435
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name SUE KIM
    Title Professor
    Telephone +82-2-2228-3276
    Affiliation Yonsei University
    Address College of Nursing, 50-1 Yonsei-ro, Seodaemun-gu, Seoul
    Contact Person for Public Queries
    Name SUE KIM
    Title Professor
    Telephone +82-2-2228-3276
    Affiliation Yonsei University
    Address College of Nursing, 50-1 Yonsei-ro, Seodaemun-gu, Seoul
    Contact Person for Updating Information
    Name SUE KIM
    Title Professor
    Telephone +82-2-2228-3276
    Affiliation Yonsei University
    Address College of Nursing, 50-1 Yonsei-ro, Seodaemun-gu, Seoul
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2017-06-17 Actual
    Target Number of Participant 50
    Primary Completion Date 2018-08-23 , Actual
    Study Completion Date 2018-10-15 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Yonsei University Health System, Severance Hospital
    Recruitment Status Completed
    Date of First Enrollment 2017-06-17 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name National Research Foundation
    Organization Type Government
    Project ID 2015R1D1A1A01059846
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Yonsei University
    Organization Type University
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Cancer related fatigue (CRF) is the most common issue affecting cancer survivors, which greatly influences quality of life. While physical activity can alleviate CRF as well as having a positive effect on cancer outcomes, cancer survivors have low rates of physical activity and often cite CRF as a barrier. This study developed an exercise adherence program for breast cancer survivors with moderate or greater CRF, and tested its efficacy. 
    Following the IMP protocol, the BLESS program (Better Life after cancer – Energy, Strength, and Support) for exercise adherence was developed as a 12 week, weekly program. The exercise component focused on strengthening core muscles (low, moderate, high intensity) with minimal burden to upper extremities, and small groups focusing on bonding and bridging as social capital components. As a RCT design, the experimental group (n=23) participated in the BLESS program.  Weekly text messages to encourage continuation were sent to both the experimental and the control (n=25) groups. Measurement of exercise adherence, physical, psychosocial, and biological parameters were done at 5 points: baseline (M1) and immediately after (M2) the 12 week program, and 1 month (M3), 6 months (M4), and 12 months (M5) following completion. The comparison group received the exercise component after M2 measurement. Both groups were homogeneous at baseline. There were statistically significant differences in exercise adherence, intention to exercise, CRF, IL-6 and TNF-α, quality of life, menopausal symptoms, and physical endurance and lower muscle strength over time. There were no differences by group and time interaction. This may be related to participants mostly being early survivors (<2 years), who had unmet needs regarding CRF management and exercise, and were highly motivated. Another factor may be the cancer recurrence and death of one participant during the BLESS program, which affected the experimental group. Finally, strategies for translation and dissemination of study findings into practicum were identified, such as linking with the national cancer information center.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
     Supportive Care
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Single
    Blinded Subject Subject
    Allocation RCT
    Intervention Type Behavioral  
    Intervention Description
    The 12-week BLESS exercise adherence program consisted of an introductory phase (6 weeks) of supervised small group exercise, followed by an adaptation phase (6 weeks) of home-based exercise. There were a total of 8 face-to-face sessions.
    Number of Arms 2
    Arm 1

    Arm Label

    Experimental group

    Target Number of Participant

    23

    Arm Type

    Experimental

    Arm Description

    The intervention group participated in a 12-week exercise adherence program, consisting of small group sessions to activate social capital while targeting cancer-related fatigue (CRF) in supervised physical exercises supplemented by home-based physical exercises.
    Arm 2

    Arm Label

    Attention Control group

    Target Number of Participant

    27

    Arm Type

    No intervention

    Arm Description

    The control group was only given written information on exercise and for follow up periods, craft activities were provided to encourage follow up. Upon completion of the study, the control group was offered an exercise session as a group.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (C00-D48)Neoplasms 
       (C50.99)Malignant neoplasm of breast unspecified, unspecified side 

    Breast cancer Cancer survivorship Cancer-related fatigue Exercise adherence Quality of life RCT
    Rare Disease No
    Inclusion Criteria

    Gender

    Female

    Age

    20Year~69Year

    Description

    • Breast cancer stages I-III
    • Completion of surgery and chemotherapy
    • NRS 4 or greater level of fatigue
    • Within 5 years since cancer diagnosis
    • At least 6 months past cancer diagnosis
    Exclusion Criteria
    • Underlying factors contributable to fatigue, i.e., cardiovascular disease, thyroid disease
    • Recurrent breast cancer or other concurrent cancers
    • Diagnosis of panic disorders, schizophrenia, bipolar disease
    • Determined unfit for low to moderate level exercise
    • Pregnant status
    • Those enrolled in regular exercise programs (pilates, yoga, PT, fitness)
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    GPAQ + walking, exercise adherence (EARS)
    Timepoint
    Baseline (M1), 12 weeks (M2, post-intervention), 1 month later (M3), 6 months later (M4), 12 months later (M5)
    Primary Outcome(s) 2
    Outcome
    Fatigue (R-PFS)
    Timepoint
    Baseline (M1), 12 weeks (M2, post-intervention), 1 month later (M3), 6 months later (M4), 12 months later (M5)
    Primary Outcome(s) 3
    Outcome
    QOL (FACT-B)
    Timepoint
    Baseline (M1), 12 weeks (M2, post-intervention), 1 month later (M3), 6 months later (M4), 12 months later (M5)
    Primary Outcome(s) 4
    Outcome
    Sleep quality (K-PSQI)
    Timepoint
    Baseline (M1), 12 weeks (M2, post-intervention), 1 month later (M3), 6 months later (M4), 12 months later (M5)
    Primary Outcome(s) 5
    Outcome
    Depression, anxiety (K-HADS); post-traumatic growth (K-PTGI)
    Timepoint
    Baseline (M1), 12 weeks (M2, post-intervention), 1 month later (M3), 6 months later (M4), 12 months later (M5)
    Primary Outcome(s) 6
    Outcome
    anthropometric measurements
    Timepoint
    Baseline (M1), 12 weeks (M2, post-intervention), 1 month later (M3), 6 months later (M4), 12 months later (M5)
    Primary Outcome(s) 7
    Outcome
    Serum cytokines
    Timepoint
    Baseline (M1), 12 weeks (M2, post-intervention), 6 months later (M4)
    Secondary Outcome(s) 1
    Outcome
    Anthropometric measurements (BMI, BP, PR, WC, inbody)
    Timepoint
    Baseline (M1), 12 weeks (M2, post-intervention), 1 month later (M3), 6 months later (M4), 12 months later (M5)
    Secondary Outcome(s) 2
    Outcome
    Menopausal symptoms (FACT-ES)
    Timepoint
    Baseline (M1), 6 months later (M4), 12 months later (M5)
    Secondary Outcome(s) 3
    Outcome
    Motivational readiness for exercise (TPB variables)
    Timepoint
    Baseline (M1), 12 weeks (M2, post-intervention), 1 month later (M3), 6 months later (M4), 12 months later (M5)
    Secondary Outcome(s) 4
    Outcome
    Bonding & bridging social capital (PSCS)
    Timepoint
    Baseline (M1), 12 weeks (M2, post-intervention), 6 months later (M4), 12 months later (M5)
    Secondary Outcome(s) 5
    Outcome
    Sociodemographics
    Timepoint
    Baseline (M1)
    Secondary Outcome(s) 6
    Outcome
    Disease-related characteristics
    Timepoint
    Baseline (M1)
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered Yes
    Published
    Results Upload
    Final Enrollment Number 48
    Number of Publication 4
    Publications 1
    Sue Kim & Yun Hee Ko & Yoonkyung Song & Min Jae Kang & Hyojin Lee & Sung Hae Kim & Justin Y. Jeon & Young Up Cho & Gihong Yi & Jeehee Han. Development of an exercise adherence program for breast cancer survivors with cancer-related fatigue—an intervention mapping approach. Supportive Care in Cancer. SCI. 2019-04-10 ,
    														 VOL : 27 page : 4745 ~ 4752
    														https://doi.org/10.1007/s00520-019-04785-2
    														
    Publications 2
    Sue Kim & Yun Hee Ko & Yoonkyung Song & Min Jae Kang & Hyojin Lee & Sung Hae Kim & Justin Y. Jeon & Young Up Cho & Gihong Yi & Jeehee Han. Pre-post analysis of a social capital-based exercise adherence intervention for breast cancer survivors with moderate fatigue: a randomized controlled trial. Supportive Care in Cancer. SCI. 2020-02-26 ,
    														 VOL : 28 page : 5281 ~ 5289
    														https://doi.org/10.1007/s00520-020-05363-7
    														
    Publications 3
    Sue Kim & Jeehee Han &Min Young Lee & Min Kyeong Jang. The experience of cancer-related fatigue, exercise and exercise adherence among women breast cancer survivors: Insights from focus group interviews. Journal of Clinical Nursing. SCI. 2019-11-19 ,
    														 VOL : 29 page : 758 ~ 769
    														DOI: 10.1111/jocn.15114
    														
    Publications 4
    Sung Hae Kim, Yoon Kyung Song, Jeehee Han, Yun Hee Ko, Hyojin Lee, Min Jae Kang, Hyunki Park, Hyangkyu Lee, Sue Kim. Pro-inflammatory Cytokine Levels and Cancer-related Fatigue in Breast Cancer Survivors: Effects of an Exercise Adherence Program. Journal of Breast Cancer. SCI. 2020-04-23 ,
    														 VOL : 23 page : 205 ~ 217
    														https://doi.org/10.4048/jbc.2020.23.e22
    														
    Results Upload 최종보고서 (BLESS 운동유지 프로그램).pdf
    Date of Posting Results 2021/01/11
    Protocol URL or File Upload (2019) Development of an exercise adherence program_IMP.pdf
    Brief Summary
    Two performance objectives (survivors adopt and maintain exercise and survivors cope with fatigue) and 17 change objectives were generated. Also, we designed theory-based methods of change, and strategies for practical application. A structured program plan that includes intervention content and methods, ranges, and program data was proposed. Finally, an implementation and evaluation plan was developed.
    
    After participating in BLESS, the CRF behavioral/severity domain significantly decreased (t = 2.642, p = 0.011) and physical activity significantly increased (t = −2.049, p = 0.046) in the intervention group, in comparison with the control group; there were no significant post-intervention differences in the control group. Both groups showed improvements in sleep quality, depression, anxiety, and QOL. The BLESS intervention improved CRF in BCS immediately at post-intervention, and this study presents clinical feasibility for the management of CRF in BCS in the early survivorship phase who are already experiencing fatigue.
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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