UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036656 |
|---|---|
| Receipt number | R000041761 |
| Scientific Title | Development and evaluation of a nursing intervention program to manage fear of recurrence in breast cancer survivors |
| Date of disclosure of the study information | 2019/05/06 |
| Last modified on | 2020/05/06 14:16:16 |
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Basic information
Public title
Development and evaluation of a nursing intervention program to manage fear of recurrence in breast cancer survivors
Acronym
Nursing intervention to manage fear of recurrence in breast cancer survivors
Scientific Title
Development and evaluation of a nursing intervention program to manage fear of recurrence in breast cancer survivors
Scientific Title:Acronym
Nursing intervention to manage fear of recurrence in breast cancer survivors
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to develop and evaluate of a nursing intervention program to manage fear of recurrence in breast cancer survivors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
fear of cancer recurrence: Japanese version of the Concerns About Recurrence Scale (CARS-J)
Participants will be assessed at baseline, immediately after completing the intervention, and 3 months later.
Key secondary outcomes
1.anxiety and depression: Hospital anxiety and depression scale (HADS)
2.QOL: Functional Assessment of Cancer Therapy-Breast (FACT-B)
3.coping: Mental Adjustment to Cancer (MAC) scale
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention program consists of 5 weekly sessions that includes 3 support groups and 2 counseling sessions to help each participant promote stress management, symptom management, and health behaviors.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
Women are eligible to participate if they
; have a confirmed past diagnosis of breast cancer
; have a fear of cancer recurrence
; are 6 months or more and less than 10 years from the curative treatment, except for hormonal therapy
; are disease-free at the start of the intervention
; can read and write Japanese
and; can give informed consent.
Key exclusion criteria
Patients are ineligible to participate if they have serious cognitive disorder and psychiatric disease.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Sayoko |
| Middle name | |
| Last name | Yuasa |
Organization
Graduate School of Nursing Art and Science, University of Hyogo
Division name
Clinical Nursing
Zip code
673-8588
Address
13-71 Kitaoji-cho Akashi Hyogo Japan
TEL
078-925-9404
nitmfor-bcs@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Sayoko |
| Middle name | |
| Last name | Yuasa |
Organization
Graduate School of Nursing Art and Science, University of Hyogo
Division name
Clinical Nursing
Zip code
673-8588
Address
13-71 Kitaoji-cho Akashi Hyogo Japan
TEL
078-925-9404
Homepage URL
nitmfor-bcs@yahoo.co.jp
Sponsor or person
Institute
Graduate School of Nursing Art and Science, University of Hyogo
Institute
Department
Personal name
Funding Source
Organization
The Yasuda Medical Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
College of Nursing Art and Science, University of Hyogo, & Research Institute of Nursing Care for People and Community Research Ethics Committee
Address
13-71 Kitaoji-cho Akashi Hyogo Japan
Tel
078-925-0860
hiroshi_tomita@cnas.u-hyogo.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
兵庫県立がんセンター（兵庫県）、兵庫県立淡路医療センター（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
22
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 06 | Day |
Last modified on
| 2020 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041761
