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Tobacco internet interventions for cancer survivors


- candidate number25252
- NTR NumberNTR6011
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-sep-2016
- Secondary IDsNL55921.101.16 KWF TI 2014-7169
- Public TitleTobacco internet interventions for cancer survivors
- Scientific TitleTobacco internet interventions for cancer survivors
- ACRONYM
- hypothesisInternet-based unguided self-help interventions for smoking cessation (SC) will show favourable effectiveness compared to the control group (internet-based information brochure on smoking cessation), 6 months post-randomisation.
- Healt Condition(s) or Problem(s) studiedSmoking
- Inclusion criteriaInclusion criteria
• Age 18+
• Recent (last 5 years) diagnosis of any form of cancer
• PC and internet connection available at home
• Ability and intention to participate in the study and the intervention during the period of one year
• Informed consent provided
• Cigarette use of >=5 cigarettes per day in the last 7 days
• Intention to quit smoking cigarettes as assessed by question 9 in the screening questionnaire
- Exclusion criteriaA potential subject who meets any of the following criteria will be excluded from participation in this study.
Exclusion criteria
• Insufficient mastery of Dutch language
• Self-reported suicidal ideation, acute psychosis, severe alcohol dependence, dementia, severe depression
• Pregnancy
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- control[default]
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2016
- planned closingdate1-mrt-2019
- Target number of participants419
- InterventionsBased on positive early experiences, the smoking cessation (SC) intervention in this study will be based on CBT, motivational interviewing, self-control principles as described in the ‘Handbook for CBT for substance abuse and gambling’ and acceptance and commitment therapy (ACT). The intervention will be a 100% self-help multi-session internet-based smoking cessation program. The intervention will also provide additional human support in the shape of a moderated peer-to-peer discussion forum.

Control-condition
The control-condition intervention will provide plain information on risks of smoking in general and especially for cancer survivors. The control interventions will also provide tips on how to quit smoking. All information will be based on existing prevention brochures developed or maintained by the Trimbos institute, which will be tailored to cancer survivors. Participants can visit the control intervention pages as often as they want during the study period. However the information on these pages is static, will not change over time, and is not tailored to the individual participant.
- Primary outcomePrimary outcome variables are the Timeline FollowBack (TLFB) scores on tobacco use in the past 7 days (tobacco RCT) at 6 months post-randomisation. Main study parameter is tobacco abstinence post-randomisation and will be measured at all measurement waves.
- Secondary outcomeSecondary outcome measures include: Quality of life, treatment satisfaction, nicotine dependence, and 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.
- TimepointsMeasurement waves will take place at baseline and 3, 6, and 12 months post-randomisation.
- Trial web sitewww.mijnkoersroken.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Ajla Mujcic
- CONTACT for SCIENTIFIC QUERIESMSc Matthijs Blankers
- Sponsor/Initiator Trimbos-institute - Netherlands Institute of Mental Health and Addiction
- Funding
(Source(s) of Monetary or Material Support)
KWF Kankerbestrijding
- PublicationsWe intend to publish in international peer-reviewed journals
- Brief summaryBecause of developments in early detection and treatment, many adult cancer survivors can expect to live for many years after treatment. However, cancer survivors are at an increased risk for recurrence and secondary cancers. As smoking and alcohol (mis)use are among the main risk factors for developing cancers, reducing tobacco and alcohol misuse contributes considerably to the prevention of second cancers among cancer survivors, as well as to improving their quality of life.

Therefore we intend to test the effectiveness of an optimized smoking cessation internet intervention in a sample of cigarette smoking cancer survivors, in comparison to a control condition (internet-based information brochure on smoking).
- Main changes (audit trail)15-jul-2017 MT:
Inclusion criteria:
“Recent (last 5 years) diagnosis of any form of cancer”
Replaced by
Diagnosis of any form of cancer in the last 10 years

Blinding: single -> none
- RECORD1-sep-2016 - 5-aug-2017


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