Table 1

Study information

Data categoryInformation
Primary registry and trial identifying noClinicalTrials.gov NCT05365269; any important protocol modifications will be communicated here
Date of registration in primary registry5 May, 2022
Secondary identifying numbersD850000001
Source(s) of monetary or material supportDeutsche Krebshilfe (German Cancer Aid)
University Medicine Greifswald
Primary sponsorUniversity Medicine Greifswald
Secondary sponsor(s)Deutsche Krebshilfe (German Cancer Aid)
Principal investigatorsJF-A, Prof. Dr.—Design, preparation of protocol, publication of study reports, trial management
UJ, Prof. Dr.—Design, preparation of protocol, publication of study reports
Data management teamAT, FK, KS— Maintenance of trial IT system and data entry, data verification, data cleansing, participant flow documentation,
Contact for public queriesJF-A, Prof. Dr. (see corresponding author information)
AT (see CTN record)
Contact for scientific queriesJF-A, Prof. Dr. (see corresponding author information)
Public titleProactive automatised lifestyle intervention for cancer prevention in general hospital patients
Scientific titleProactive automatised lifestyle intervention to prevent cancer in general hospital patients
Country of recruitmentGermany
Health condition(s) or problem(s) studiedHospitalisation at a general hospital, irrespective of reason for admission and health risk behaviour profile
Intervention(s)Proactive automatised lifestyle intervention consisting of computer-generated, individually tailored feedback on health risk behaviours; 3 times over 3 months
Key inclusion and exclusion criteriaAges eligible for study: 18–64 years
Sexes eligible for study: both
Accepts healthy volunteers: no
Inclusion criteria: General hospital patients admitted to participating wards of five medical departments (internal medicine A and B, surgical medicine, trauma medicine, ear-nose-throat-medicine)
Exclusion criteria: patient cognitively or physically incapable, patient with highly infectious disease, patient discharged or transferred within the first 24 hours, patient already asked for participation during previous hospital stay, patient with insufficient language skills, patient employed at the conducting research institute, patient with neither telephone nor email
Study typeInterventional
Allocation: All patients receive intervention
Intervention model: Single-group assignment
Masking: non-blinded as participants are informed about the intervention prior to participation
Primary purpose: prevention
Date of first enrolment31 May 2022
Target sample size175
Recruitment statusCompleted: 5 July 2022
Date of final data collectionAnticipated: 31 March 2023
Primary outcome(s)Intervention reach (time frame: month 0)
Intervention retention (time frame: months 1, 3)
Key secondary outcomesSatisfaction with intervention (time frame: month 6)
Change in health risk behaviours, that is, physical activity, diet, alcohol use, tobacco smoking, sum of health risk behaviours (time frame: months 0, 1, 3, 6)
Change in motivational measures, that is, stage of change, self-efficacy, decisional balance, processes of change (time frame: months 0, 1, 3, 6)
Change in health-related measures, that is, body mass index, general health, mental health, number of sick days, non-communicable diseases, utilisation of healthcare (time frame: months 0, 6)