Data category | Information |
Primary registry and trial identifying no | ClinicalTrials.gov NCT05365269; any important protocol modifications will be communicated here |
Date of registration in primary registry | 5 May, 2022 |
Secondary identifying numbers | D850000001 |
Source(s) of monetary or material support | Deutsche Krebshilfe (German Cancer Aid) University Medicine Greifswald |
Primary sponsor | University Medicine Greifswald |
Secondary sponsor(s) | Deutsche Krebshilfe (German Cancer Aid) |
Principal investigators | JF-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 team | AT, FK, KS— Maintenance of trial IT system and data entry, data verification, data cleansing, participant flow documentation, |
Contact for public queries | JF-A, Prof. Dr. (see corresponding author information) AT (see CTN record) |
Contact for scientific queries | JF-A, Prof. Dr. (see corresponding author information) |
Public title | Proactive automatised lifestyle intervention for cancer prevention in general hospital patients |
Scientific title | Proactive automatised lifestyle intervention to prevent cancer in general hospital patients |
Country of recruitment | Germany |
Health condition(s) or problem(s) studied | Hospitalisation 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 criteria | Ages 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 type | Interventional 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 enrolment | 31 May 2022 |
Target sample size | 175 |
Recruitment status | Completed: 5 July 2022 |
Date of final data collection | Anticipated: 31 March 2023 |
Primary outcome(s) | Intervention reach (time frame: month 0) Intervention retention (time frame: months 1, 3) |
Key secondary outcomes | Satisfaction 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) |