UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052615 |
|---|---|
| Receipt number | R000060041 |
| Scientific Title | A clinical study of a remote lifestyle support program for cancer patients receiving systemic chemotherapy |
| Date of disclosure of the study information | 2023/10/26 |
| Last modified on | 2023/10/25 18:51:59 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A clinical study of a remote lifestyle support program for cancer patients receiving systemic chemotherapy
Acronym
A clinical study of a remote lifestyle support program for cancer patients receiving systemic chemotherapy
Scientific Title
A clinical study of a remote lifestyle support program for cancer patients receiving systemic chemotherapy
Scientific Title:Acronym
A clinical study of a remote lifestyle support program for cancer patients receiving systemic chemotherapy
Region
| Japan |
Condition
Condition
Gastric or colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Rehabilitation medicine |
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
NA
Basic objectives2
Others
Basic objectives -Others
NA
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Completion rate of online lifestyle support
Mobile app usage (frequency of use, time spent in app)
Key secondary outcomes
Percentage of questionnaire responses
Lifestyle changes (physical activity, diet, diet-related quality of life, and changes in fatigue scores)
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Lifestyle support program under online
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) The study is fully explained and written consent is obtained from the patient.
2) Patients must be at least 18 years of age at the time of enrollment.
3) Patients must have primary cancer of the stomach or colon (including post-resection)
4) Patients are scheduled to receive at least 3 months of outpatient pharmacotherapy with a regimen including SOX/DS/CAPOX
5) Able to take oral intake.
Key exclusion criteria
1) Musculoskeletal, cardiovascular, or cerebral nervous system disease requiring exercise restriction
2) Patient has a metabolic/endocrine, cardiovascular, or hepatic/renal disease requiring special nutritional guidance.
3) Other conditions that the physician deems inappropriate.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroya |
| Middle name | |
| Last name | Taniguchi |
Organization
Aichi Cancer Center Hospital
Division name
Department of Clinical Oncology
Zip code
464-8681
Address
1-1, Kanokoden, Chikusa-ku, Nagoya
TEL
0527626111
hiroya.taniguchi@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Hiroya |
| Middle name | |
| Last name | Taniguchi |
Organization
Aichi Cancer Center Hospital
Division name
Department of Clinical Oncology
Zip code
464-8681
Address
1-1, Kanokoden, Chikusa-ku, Nagoya
TEL
0527626111
Homepage URL
hiroya.taniguchi@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Aichi Cancer Center
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
Aichi Cancer Center Institutional Review Board
Address
1-1 Kanokoden, Chikusa-ku Nagoya, Aichi, Japan
Tel
0527626111
irb@aichi-cc.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 | 10 | Month | 26 | 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
| 2023 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | 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 | 10 | Month | 25 | Day |
Last modified on
| 2023 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060041
