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
CRIS Registration Number |
KCT0005763 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | National Research Foundation |
Organization Type | Government |
Project ID | 2015R1D1A1A01059846 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Yonsei University |
Organization Type | University |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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 |
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Arm Type Experimental |
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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. |
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Arm 2 |
Arm Label Attention Control group |
Target Number of Participant 27 |
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Arm Type No intervention |
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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
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 |
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Rare Disease | No |
Inclusion Criteria |
Gender Female |
Age 20Year~69Year |
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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 |
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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)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | GPAQ + walking, exercise adherence (EARS) |
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Timepoint | Baseline (M1), 12 weeks (M2, post-intervention), 1 month later (M3), 6 months later (M4), 12 months later (M5) |
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Primary Outcome(s) 2 | ||
Outcome | Fatigue (R-PFS) |
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Timepoint | Baseline (M1), 12 weeks (M2, post-intervention), 1 month later (M3), 6 months later (M4), 12 months later (M5) |
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Primary Outcome(s) 3 | ||
Outcome | QOL (FACT-B) |
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Timepoint | Baseline (M1), 12 weeks (M2, post-intervention), 1 month later (M3), 6 months later (M4), 12 months later (M5) |
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Primary Outcome(s) 4 | ||
Outcome | Sleep quality (K-PSQI) |
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Timepoint | Baseline (M1), 12 weeks (M2, post-intervention), 1 month later (M3), 6 months later (M4), 12 months later (M5) |
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Primary Outcome(s) 5 | ||
Outcome | Depression, anxiety (K-HADS); post-traumatic growth (K-PTGI) |
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Timepoint | Baseline (M1), 12 weeks (M2, post-intervention), 1 month later (M3), 6 months later (M4), 12 months later (M5) |
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Primary Outcome(s) 6 | ||
Outcome | anthropometric measurements |
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Timepoint | Baseline (M1), 12 weeks (M2, post-intervention), 1 month later (M3), 6 months later (M4), 12 months later (M5) |
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Primary Outcome(s) 7 | ||
Outcome | Serum cytokines |
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Timepoint | Baseline (M1), 12 weeks (M2, post-intervention), 6 months later (M4) |
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Secondary Outcome(s) 1 | ||
Outcome | Anthropometric measurements (BMI, BP, PR, WC, inbody) |
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Timepoint | Baseline (M1), 12 weeks (M2, post-intervention), 1 month later (M3), 6 months later (M4), 12 months later (M5) |
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Secondary Outcome(s) 2 | ||
Outcome | Menopausal symptoms (FACT-ES) |
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Timepoint | Baseline (M1), 6 months later (M4), 12 months later (M5) |
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Secondary Outcome(s) 3 | ||
Outcome | Motivational readiness for exercise (TPB variables) |
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Timepoint | Baseline (M1), 12 weeks (M2, post-intervention), 1 month later (M3), 6 months later (M4), 12 months later (M5) |
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Secondary Outcome(s) 4 | ||
Outcome | Bonding & bridging social capital (PSCS) |
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Timepoint | Baseline (M1), 12 weeks (M2, post-intervention), 6 months later (M4), 12 months later (M5) |
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Secondary Outcome(s) 5 | ||
Outcome | Sociodemographics |
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Timepoint | Baseline (M1) |
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Secondary Outcome(s) 6 | ||
Outcome | Disease-related characteristics |
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Timepoint | Baseline (M1) |
11. Study Results and Publication
Result Registered |
Yes
Published Results Upload |
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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 Statement | No |
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