UMIN-CTR Clinical Trial

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
Email	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
Email	nitmfor-bcs@yahoo.co.jp

Sponsor
Institute	Graduate School of Nursing Art and Science, University of Hyogo
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041761