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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031313
Receipt No. 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 2020/01/22

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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
Email 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
Email riskcheck_RCT@ml.res.ncc.go.jp

Sponsor
Institute National Cancer Center, Japan
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 6534
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
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
2020 Year 01 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_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


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