UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000031313 |
|---|---|
| Receipt number | R000035738 |
| Scientific Title | Effectiveness of personalized advice using a cancer risk prediction tool on modifying lifestyle habits: a randomized controlled trial |
| Date of disclosure of the study information | 2018/02/16 |
| Last modified on | 2021/08/24 16:58:28 |
* 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
Effectiveness of personalized advice using a cancer risk prediction tool on modifying lifestyle habits: a randomized controlled trial
Acronym
A cancer risk prediction tool for lifestyle modification: a randomized controlled trial
Scientific Title
Effectiveness of personalized advice using a cancer risk prediction tool on modifying lifestyle habits: a randomized controlled trial
Scientific Title:Acronym
A cancer risk prediction tool for lifestyle modification: a randomized controlled trial
Region
| Japan |
Condition
Condition
Healthy participants
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of giving personalized advice using a probability calculated by a prediction model of cumulative cancer risk based on lifestyle factors on lifestyle modification, compared to standard advice for the prevention of cancer not using risk probability. After the advice was given, all randomized individuals were invited to participate in the same program for lifestyle modification.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in lifestyle within 6 months after receiving an advice
We defined the five healthy lifestyle habits as non-smoking, moderate or no alcohol consumption, moderate salt intake, adequate physical activity, and appropriate body mass index. Participants were assigned a score of 1 if they had the healthy lifestyle habit and a score of 0 if they did not. The individual scores were then summed and used as an index (5 = no risk factors; 0 = all risk factors). The primary outcome was defined as an increase in the index within 6 months after receiving an advice.
Key secondary outcomes
1. Participation in a program for lifestyle modification within 6 months after receiving an advice
2. Change in lifestyle within 12 months after receiving an advice
3. Change in each lifestyle habit within 6 and 12 months after receiving an advice
4. Associations between lifestyle at baseline or change in lifestyle and lifestyle-related diseases or death as an observational study
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention group was given personalized advice based on a probability calculated by a prediction model of 10-year cumulative cancer risk according to five healthy lifestyle habits, and invited to participate in a program for lifestyle modification.
Interventions/Control_2
The control group was given standard advice about lifestyle modification for the prevention of cancer and invited to participate in the same program as the intervention group.
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
| 40 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Individuals who bought life insurance from The Dai-ichi Life Insurance Company, Limited from November, 2017 to March, 2018
2) Individuals aged 40-64 years old on January 1st, 2018
3) Individuals who were both policy holders and insured persons on the life insurance contract
4) Individuals who consented to participating in this study and answered a baseline questionnaire
5) Individuals who had any one of five lifestyle habits used for calculation of cumulative cancer risk that needed improvement
We sent a consent form and a baseline questionnaire to individuals who met criteria 1-3). Individuals who met criteria 1-5) were eligible for randomization. Individuals who met criteria 1-4) were eligible for the observational study.
Key exclusion criteria
None.
Target sample size
7000
Research contact person
Name of lead principal investigator
| 1st name | Taichi |
| Middle name | |
| Last name | Shimazu |
Organization
National Cancer Center, Japan
Division name
Division of Prevention, Center for Public Health Sciences
Zip code
104-0045
Address
5-1-1 Tsukiji Chuo-ku Tokyo, Japan
TEL
03-3542-2511
tshimazu@ncc.go.jp
Public contact
Name of contact person
| 1st name | Taichi |
| Middle name | |
| Last name | Shimazu |
Organization
National Cancer Center, Japan
Division name
Division of Prevention, Center for Public Health Sciences
Zip code
104-0045
Address
5-1-1 Tsukiji Chuo-ku Tokyo, Japan
TEL
03-3547-5201(ext.3348)
Homepage URL
riskcheck_RCT@ml.res.ncc.go.jp
Sponsor or person
Institute
National Cancer Center, Japan
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
The Dai-ichi Life Insurance Company, Limited
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1 Tsukiji Chuo-ku Tokyo, Japan
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.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
国立がん研究センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 16 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/33771848/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/33771848/
Number of participants that the trial has enrolled
5891
Results
The proportion of participants who improved their lifestyle within 6 months in the intervention group did not significantly differ from that in the control group (18.4% vs. 17.7%; P = 0.488). Among participants with low health literacy and two or fewer of five healthy habits, the proportion of participants subscribing to the lifestyle modification program was higher in the intervention group than in the control group.
Results date posted
| 2021 | Year | 08 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The intervention group
Participants: 2,947 (Male: 53.1%)
Mean age: 51.3 years
The control group
Participants: 2,944 (Male: 53.1%)
Mean age: 51.2 years
Participant flow
The baseline questionnaire was sent to 59,892 eligible persons. Those of 6,534 completed the baseline questionnaire and were enrolled in the study, of whom 5,894 with one or more unhealthy lifestyle habits were randomly assigned to the intervention or control groups.
Adverse events
None.
Outcome measures
The primary outcome in the intervention group was not significantly different from that in the control group (proportion of participants who improved their lifestyle within 6 months, 18.4% vs. 17.7%; P=0.488). In the most of the secondary outcome analyses, there were no statistically significant differences between the groups. In the subgroup analyses, among participants with low health literacy and two or fewer of five healthy habits, the proportion of participants subscribing to the lifestyle modification program was higher in the intervention group than in the control group.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 27 | Day |
Date trial data considered complete
| 2020 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 15 | Day |
Last modified on
| 2021 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035738
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
