UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050384 |
|---|---|
| Receipt number | R000057359 |
| Scientific Title | Feasibility of implementation and evaluation of nursing intervention program for patients undergoing surgery for recurrent/metastatic cancer |
| Date of disclosure of the study information | 2023/02/20 |
| Last modified on | 2023/02/19 23:24:28 |
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Basic information
Public title
Development of nursing intervention program for patients undergoing second surgery for cancer
Acronym
Nursing intervention program for patients undergoing second surgery for cancer
Scientific Title
Feasibility of implementation and evaluation of nursing intervention program for patients undergoing surgery for recurrent/metastatic cancer
Scientific Title:Acronym
Feasibility of nursing intervention program for patients undergoing surgery for recurrent/metastatic cancer
Region
| Japan |
Condition
Condition
recurrent/metastatic cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective is to evaluate the feasibility and effectiveness of a nursing intervention program that utilizes primary cancer experience for patients undergoing recurrent/metastatic cancer surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in attitudes and approaches to disease and treatment: subjective and qualitative evaluation by participants
Key secondary outcomes
Self efficacy: Self-efficacy Scale for Cancer Patients (Tsukamoto, 1998)
Posttraumatic Growth: Posttraumatic Growth Inventory-Japanese; PTGI-J (Taku, 2008)
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
Interventional interviews by a nurse are conducted once before surgery and twice after surgery.
The interviews are designed to utilize primary cancer surgery experience and achieve strategies to cope with recurrent/metastatic cancer surgery and life afterwards positively.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients underwent surgery for primary cancer and are scheduled for surgery for recurrent/metastatic cancer
2) Twenty years old or older at the time of primary cancer diagnosis.
3) Those who know their diagnosis.
4) Surgery is performed for the purpose of cancer treatment, not for symptom relief.
5) Those who can recall past experiences of illness and treatment, and express current feelings and thoughts verbally.
6) Their psychological states are stable even if they remember experiences of illness and treatment.
Key exclusion criteria
1) Patients cannot recall past experiences of illnesses and treatment, and express verbally.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Miyuki |
| Middle name | |
| Last name | Konishi |
Organization
Graduate School of Nursing, Chiba University
Division name
Department of Advanced Clinical Nursing
Zip code
260-0856
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, 260-0856 Japan
TEL
043-226-2771
mkonishi@chiba-u.jp
Public contact
Name of contact person
| 1st name | Miyuki |
| Middle name | |
| Last name | Konishi |
Organization
Graduate School of Nursing, Chiba University
Division name
Department of Advanced Clinical Nursing
Zip code
260-0856
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, 260-0856 Japan
TEL
043-226-2771
Homepage URL
mkonishi@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, Graduate School of Nursing, Chiba University
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, 260-0856 Japan
Tel
043-226-2462
kango-rinri@chiba-u.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 20 | 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
10
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 19 | Day |
Last modified on
| 2023 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057359
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
