UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of nursing intervention program for promoting to sense of coherence of recurrence breast cancer patients who received chemotherapy
Acronym	Evaluation of nursing intervention for promoting to sense of coherence of recurrence breast cancer patients
Scientific Title	Evaluation of nursing intervention program for promoting to sense of coherence of recurrence breast cancer patients who received chemotherapy
Scientific Title:Acronym	Evaluation of nursing intervention for promoting to sense of coherence of recurrence breast cancer patients
Region	Japan

Condition
Condition	recurrence breast cancer
Classification by specialty	Nursing
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to clarify the effectiveness and usefulness of the nursing intervention program for promote the SOC of breast cancer patients diagnosed with recurrence and undergoing chemotherapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Anxiety and depression;Hospital Anxiety and Depression Scale
Key secondary outcomes	Sense of coherence;Sense of coherence Scale Quality of Life;SF-12v2

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	The goal of the program is to improve SOC, to decrease anxiety and depression, and to restore QOL for the patients. The program addresses;support patients to express negative emotions and to sort through emotions and thoughts, assist patients to obtain information of the recurrent cancer and chemotherapy, and support patients to cope constructively with negative emotions. We decided to intervene with the narrative approach. The intervention period was one and a half months from the start of the first chemotherapy, and there were three times interventions.
Interventions/Control_2	Control group;Receive regular care of the nurse at the facility.
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	79 years-old >=
Gender	Female
Key inclusion criteria	1.A female breast cancer patient who has distant metastasis and undergoing chemotherapy. 2.Chemotherapy includes oral anti-cancer drugs and drip anti-cancer drugs including molecular targeted drugs.
Key exclusion criteria	1.Breast cancer patients with local recurrence 2.Breast cancer patients with first advanced cancer 3.Recurrent breast cancer patients who receive endocrine therapy, radiation therapy, surgery, or immunotherapy alone 4.Patients who have relapsed and are receiving multiple times chemotherapy 5.Patients who appear to be in confusion or panic
Target sample size	5

Research contact person
Name of lead principal investigator	1st name KUMI Middle name Last name SUZUKI
Organization	Osaka Medical and Pharmaceutical University
Division name	Faculty of Nursing
Zip code	569-0095
Address	7-6, Hatchonishi-machi, Takatsuki, Osaka
TEL	072-684-7281
Email	kumi.suzuki@ompu.ac.jp

Public contact
Name of contact person	1st name KUMI Middle name Last name SUZUKI
Organization	Osaka Medical and Pharmaceutical University
Division name	Faculty of Nursing
Zip code	569-0095
Address	7-6, Hatchonishi-machi, Takatsuki, Osaka
TEL	072-684-7281
Homepage URL
Email	kumi.suzuki@ompu.ac.jp

Sponsor
Institute	Osaka Medical and Pharmaceutical University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Osaka Medical and Pharmaceutical University hospital Yodogawa christian hospital Hyogo prefectural nishinomiya hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee of Osaka Medical and Pharmaceutical University
Address	2-7 Daigaku-machi, Takatsuki, Osaka
Tel	072-683-1221
Email	rinri@ompu.ac.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	大阪医科薬科大学（大阪府）

Other administrative information
Date of disclosure of the study information	2019 Year 08 Month 15 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	5
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2022 Year 03 Month 25 Day
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 05 Month 10 Day
Date of IRB	2019 Year 05 Month 10 Day
Anticipated trial start date	2019 Year 07 Month 26 Day
Last follow-up date	2021 Year 10 Month 31 Day
Date of closure to data entry	2021 Year 10 Month 31 Day
Date trial data considered complete	2021 Year 10 Month 31 Day
Date analysis concluded	2021 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 08 Month 08 Day
Last modified on	2022 Year 02 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042905