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Effects of a randomized controlled trial of a partnership-based, needs-tailored self-management support intervention for post-treatment breast cancer survivors

Status Approved

  • First Submitted Date

    2020/02/12

  • Registered Date

    2020/03/05

  • Last Updated Date

    2020/02/28

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    		 KCT0004794
    Unique Protocol ID 2019-11-040
    Public/Brief Title Development of post-treatment health managment program for breast cancer survivors
    Scientific Title Effects of a randomized controlled trial of a partnership-based, needs-tailored self-management support intervention for post-treatment breast cancer survivors
    Acronym EMPOWER
    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 2019-11-040
    Approval Date 2019-12-30
    Institutional Review Board Name Institutional Review Board of Inha University Hospital
    Institutional Review Board Address 27, Inhang-ro, Jung-gu, Incheon
    Institutional Review Board Telephone 032-890-3691
    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 Soo Hyun Kim
    Title Prof.
    Telephone +82-32-860-8213
    Affiliation Inha University
    Address 100 Inha-ro, Michuhol-gu, Incheon
    Contact Person for Public Queries
    Name Soo Hyun Kim
    Title Prof.
    Telephone +82-32-860-8213
    Affiliation Inha University
    Address 100 Inha-ro, Michuhol-gu, Incheon
    Contact Person for Updating Information
    Name Soo Hyun Kim
    Title Prof.
    Telephone +82-32-860-8213
    Affiliation Inha University
    Address 100 Inha-ro, Michuhol-gu, Incheon

  • 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 Multi-center Number of center : 2
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2020-01-20 Actual
    Target Number of Participant 94
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Inha University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2020-01-20 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Yonsei University Health System, Severance Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-03-02 ,

  • 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 Others
    Project ID

  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Inha University
    Organization Type University

  • 7. Study Summary

    Study Summary Information
    Lay Summary 
    Self-management is becoming essential for breast cancer survivors, but evidence about the effectiveness of self-management support (SMS) intervention is lacking. To address this issue, we developed a theory-based SMS intervention aimed at empowering breast cancer survivors. Here we describe the rationale of the intervention and its development.

Hypotheses
- The intervnetion group will demonstrate a significant increase in empowerment and self-efficacy compared to the control group.
- The intervnetion group will demonstrate a significant decrease in anxiety and depression compared to the control group.
- - The intervnetion group will demonstrate a significant increase in mental adjustment and health-related quality of life compared to the control group.

  • 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 Open
    Allocation RCT
    Intervention Type Behavioral  
    Intervention Description 
    1. Intervention group: 7-week partnership-based, needs-tailored self-management support program.
- contents: medical management(Mx), symptom Mx, lifestyle Mx, emotional Mx, and role Mx after cancer treatment
- delivery method: telephone counseling (10 sessions, total 175 minutes)
- providers: nursing professor, trained master-level nurse

2. Control group: wait-list control group
- Participants in the control group receive an education material(51 pages) for self-managment after cancer treatment.
- contents: medical management(Mx), symptom Mx, lifestyle Mx, emotional Mx, and role Mx after cancer treatment

3. Difference between the two groups: the control group receive an educational material, whereas, the intervention group receive a telephone counseling aimed at empowering and fostering self-management skill training.
    Number of Arms 2
    Arm 1

    Arm Label

    Intervention group

    Target Number of Participant

    47

    Arm Type

    Experimental

    Arm Description

    7-week partnership-based, needs-tailored self-management support program.
- contents: medical management(Mx), symptom Mx, lifestyle Mx, emotional Mx, and role Mx after cancer treatment
- delivery method: telephone counseling (10 sessions, total 175 minutes)
- providers: nursing professor, trained master-level nurse
    Arm 2

    Arm Label

    Control group

    Target Number of Participant

    47

    Arm Type

    Active comparator

    Arm Description

    The control group receive an educational material for self-management after breast cancer treatment.

  • 9. Subject Eligibility

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

    breast neoplasm
    Rare Disease No
    Inclusion Criteria

    Gender

    Female

    Age

    19Year~No Limit

    Description

    women
1) are aged 19 years or more
2) were diagnosed histologically with breast cancer
3) completed a primary cancer treatment within the previous 6 months (except for anti-hormone therapy and targeted therapy) 
4) were treated with one of a curative cancer therapy (surgery, chemotherapy, or radiation therapy)
5) completed a planned cancer treatment
6) had two or more unmet needs in a post-treatment screening test covering 12 items of unmet needs concerning SM behaviors (i.e., follow-up visit, pain management, fatigue management, insomnia management, lymphedema management, exercise, diet, smoking cessation, stress management, return to work, and sexual activity)
7) are able to read and write Korean
8) are able to use the telephone
    Exclusion Criteria 
    Women will be excluded if they had a recurrence, a metastasis, or another cancer.
    Healthy Volunteers

  • 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 
    empowerment
    Timepoint 
    baseline, 8 week after enrollment, 20 week after enrollment
    Secondary Outcome(s) 1
    Outcome 
    self-efficacy
    Timepoint 
    baseline, 8 week after enrollment, 20 week after enrollment
    Secondary Outcome(s) 2
    Outcome 
    anxiety and depression
    Timepoint 
    baseline, 8 week after enrollment, 20 week after enrollment
    Secondary Outcome(s) 3
    Outcome 
    mental adjustment
    Timepoint 
    baseline, 8 week after enrollment, 20 week after enrollment
    Secondary Outcome(s) 4
    Outcome 
    health-related quality of life
    Timepoint 
    baseline, 8 week after enrollment, 20 week after enrollment

  • 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 No

  • 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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