UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035738