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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028618
Receipt No. R000032752
Scientific Title Examination of the Effect of Self Monitoring on patients with Persistent Chemotherapy-Induced Peripheral Neuropathy
Date of disclosure of the study information 2017/08/10
Last modified on 2017/08/09

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Basic information
Public title Examination of the Effect of Self Monitoring on patients with Persistent Chemotherapy-Induced Peripheral Neuropathy
Acronym Effect of Self Monitoring with PCIPN
Scientific Title Examination of the Effect of Self Monitoring on patients with Persistent Chemotherapy-Induced Peripheral Neuropathy
Scientific Title:Acronym Effect of Self Monitoring with PCIPN
Region
Japan

Condition
Condition Breast cancer, colon cancer, gynecological cancer
Classification by specialty
Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Examination of the effect of self monitoring on cancer patients with chronic peripheral neuropathy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes *The effect of self-management education
Key secondary outcomes *The Comprehensive Assessment Scale for Chemotherapy-induced Peripheral Neuropathy in Survivors of Cancer(CAS-CIPN)
*Cancer-chemotherapy Concerns Rating Scale(CCRS)
*Improve self-care capacity
*Improvement of QOL (FACT-G)
*Improvement of self-efficacy (SEAC)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 Self Monitoring with PCIPN/ Regular care
Self-monitoring type (60 people, below intervention group) / knowledge provision type (60 people, control group) Self monitoring type with self-monitoring type further self-monitoring type (30 persons, the following record book group), smartphone application ), And intervention study is conducted according to the self-monitoring conceptual model created.In both the control group and the intervention group, an interview was conducted on the start date, and peripheral nerves Do you understand lifestyle movements that do not cause numbness and pain due to obstacles, methods of massage and cold / hot menstruation, differences between acute symptoms and chronic symptoms, necessity of properly communicating the symptoms of peripheral neuropathy to medical personnel Confirm and provide supplementary explanation about missing knowledge. Three weeks, six weeks, and nine weeks later, peripheral nerve disorders and living conditions were also confirmed through interviews in both the control group and the intervention group, and the presence or absence of intervention and the perception of peripheral neuropathy by the teaching materials being used Change, coping exercises to understand changes in behaviors
<Measurement date>
* 1st, 3rd, 4th: FACT-G, SEAC, Peripheral Neuropathy Scale, Anxiety Scale, Safety Daily Behavior Checklist, Thermometers and Troublesome Thermometers
* 2nd: FACT-G, SEAC, Peripheral Neurological Disorder Scale, Anxiety Scale, Psychological and Heterostatic Thermometers
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 Male and Female
Key inclusion criteria Patients with colon cancer, breast cancer, gynecological cancer who received compliance with outpatient regimen including platinum drug and taxane drug more than three times. Including patients without peripheral neuropathy
Key exclusion criteria For each physical or mental reason, each scale measurement, patient who is difficult to interview, patients who measured cognitive function with MINI - COG and was 3 points or less
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyoko Kanda
Organization Gunma University Graduate School of Health Sciences
Division name Department of Nursing
Zip code
Address 3-39-22,Showa-machi Maebashi Gunma
TEL 027-220-8929
Email kkanda@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kiyoko Kanda
Organization Gunma University Graduate School of Health Sciences
Division name Department of Nursing
Zip code
Address 3-39-22,Showa-machi Maebashi Gunma
TEL 027-220-8929
Homepage URL
Email kkanda@gunma-u.ac.jp

Sponsor
Institute Gunma University School of Medicine
Institute
Department

Funding Source
Organization Ministry of education
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization MEXT JSPS KAKENHI Grant-in-Aid

Other related organizations
Co-sponsor Niigata College of Nursing
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 群馬大学医学部附属病院(群馬県)
新潟県立中央病院(新潟県)

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 10 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
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 Enrolling by invitation
Date of protocol fixation
2016 Year 07 Month 12 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 09 Day
Last modified on
2017 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032752

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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