leefstijl alcohol moderation smoking cessation
Conditions
Interventions
For each of the two trials, an interactive internet self-help intervention, and
a passive online information-brochure will be developed. Interventions are
based on cognitive behavioural therapy, mot
Sponsors
Trimbos-instituut
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Shared inclusion criteria (for both RCTs): - Age 18+ - Recent (last 5 years) diagnosis of any form of cancer - PC and internet connection available at home - Expects to be able and willing to participate in the study and the intervention during the period of one year - Informed consent provided;Additional inclusion criteria for the alcohol moderation (AM) RCT: - Alcohol Use Disorder Identification Test (AUDIT) score 7 drinking units in the last 7 days (>WCRF alcohol recommendation) - Intention to reduce or quit alcohol use as assessed by question 9 in the screening questionnaire;Additional inclusion criteria for the smoking cessation (SC) RCT: - Cigarette use of >
Exclusion criteria
Exclusion criteria: Shared exclusion criteria (for borth RCTs): * Insufficient mastery of Dutch language * Self-reported suicidal ideation, acute psychosis, severe alcohol dependence. dementia, severe depression * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome variables are the Timeline-Follow-Back (TLFB) scores on alcohol use in the past 7 days (alcohol RCT) and TLFB scores on tobacco use in the past 7 days (tobacco RCT). Main study parameters are the number of drinks post-randomisation (alcohol RCT), and tobacco abstinence (tobacco RCT). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life: Measured using two instruments: The 3 level version of the EQ-5D and the MOS SF-36. Both quality of life instruments are widely used in cost-utility analyses. 2. Treatment satisfaction as measured using the Dutch version of the ZUF-8 3. Alcohol use disorders identification Test (AUDIT) (AM RCT) 4. Fagerstrom test for nicotine dependence (SC RCT) 5. An additional question about tobacco use in the 14 days prior to 4 weeks after the set quit date, to comply with the Russel Standard and thus make the study better comparable to international smoking cessation studies. Other study parameters: 6. Demographics: age, sex, level of education, type of cancer, type of treatment. Participants will be asked for permission to collect their patient data from the Netherlands Cancer Registry as managed by IKNL (Integraal Kankercentrum Nederland). 7. TIC-P: Direct (non-)medical cost data and productivity losses will be measured, as well as cost data related to production losses through absenteeism and presenteeism, which will be measured through the PRODISQ. 8. Marlowe Crowne Social Desirability Scale (MCSDS) will be included to evaluate the reliability of the self-reported questionnaire data. 9. Timeline follow-back reports on alcohol use (number of standard drinks) in the 7 days prior to the measurement waves in the tobacco RCT and timeline follow-back reports on tobacco use (number of cigarettes) in the 7 days prior to the measurement waves in the alcohol RCT. 10. Alcohol Use Disorders Identification Test (AUDIT) will be included in the tobacco RCT to control for any interaction effects which might occur. The Fagerstrom will be included in the alcohol RCT to control for any interaction effects which might occur. Purported mediators: 11. AAQ-II: Acceptance and Action Questionnaire to assess experiential avoidance and psychological flexibility. 12. ACT knowledge questionnaire to assess obtained knowledge about ACT. 13. OCDS: Obsessiv | — |
Countries
Netherlands
Outcome results
None listed