UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028618 |
|---|---|
| Receipt number | 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 | 2023/02/14 10:41:28 |
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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 | Kanda |
| Middle name | |
| Last name | Kiyoko |
Organization
Gunma University Graduate School of Health Sciences
Division name
Department of Nursing
Zip code
371-8514
Address
3-39-22,Showa-machi Maebashi Gunma
TEL
027-220-8929
kkanda@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Kiyoko |
| Middle name | |
| Last name | Kanda |
Organization
Gunma University Graduate School of Health Sciences
Division name
Department of Nursing
Zip code
371-8514
Address
3-39-22,Showa-machi Maebashi Gunma
TEL
027-220-8929
Homepage URL
kkanda@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University School of Medicine
Institute
Department
Personal name
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
Gunma University
Address
Gunma Showa machi, Maebashi-city3-39-15
Tel
0272208929
kkanda@gunma-u.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
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
65
Results
There was an interaction effect between the CG and SMG regarding self-efficacy scores. Scores were significantly higher in the SMG than in the CG after three weeks. Quality of life (QOL)scores were also higher in the SMG than in the CG. The self-monitoring intervention maintained the participants self-efficacy and QOL. This suggested its effectiveness on patients with peripheral neuropathy.
Results date posted
| 2022 | Year | 08 | Month | 16 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Because the analysis was delayed and the post was delayed
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Study details were explained to a total of 81 cancer (breast and gynecological) and colorectal cancer patients who received outpatient treatment and met the requirements for the study; 77 consenting patients were selected for participation. The patients were randomly assigned to the CG (n=38) or the SMG (n=39) as a sequential enrollment method at each institution. However, certain participants did not complete the study period as they either declined to participate after the first and second time (control n=2, intervention n=3) or declined any treatment (intervention n=1). After excluding those with incomplete data, the final number of participants was 32 in the CG and 33 in the SMG. We did not supplement the dropouts or incompletely recorded (missing) data.
Adverse events
NONE
Outcome measures
CAS-CIPN,
GOG-Ntx,
DIT,
SEAC,
FACT-G
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 29 | Day |
Date of closure to data entry
| 2020 | Year | 06 | Month | 05 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 09 | Day |
Last modified on
| 2023 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032752
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