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van CCT (UK)

van CCT (UK)

Alcohol internet interventions for cancer survivors

- candidate number25229
- NTR NumberNTR6010
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-sep-2016
- Secondary IDsNL55921.101.16 KWF TI 2014-7169
- Public TitleAlcohol internet interventions for cancer survivors
- Scientific TitleAlcohol internet interventions for cancer survivors
- hypothesisInternet-based unguided self-help interventions for alcohol moderation (AM) will show favourable effectiveness compared to the control group (internet-based information brochure on alcohol moderation), 6 months post-randomisation.
- Healt Condition(s) or Problem(s) studiedAlcohol
- 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
• Alcohol Use Disorders Identification Test (AUDIT) score <20
• Alcohol consumption of >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
- Exclusion criteriaA potential subject who meets any of the following criteria will be excluded from participation in this study. Shared exclusion criteria (for both RCTs): • 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 participants264
- InterventionsThe alcohol moderation (AM) intervention will be an interactive Dutch unguided self-help intervention for alcohol misusers, 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 also provide additional human support in the shape of a moderated peer-to-peer discussion forum.

Control-condition interventions
The two control-condition interventions will provide plain information on risks of alcohol use in general and especially for cancer survivors. The control interventions will also provide tips on how to reduce or quit alcohol use. 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 variable is the Timeline FollowBack
(TLFB) score on alcohol use in the past 7 days at 6 months post-randomisation. Main study parameter is the number of drinks post-randomisation and will be measured at all measurement waves.
- Secondary outcomeSecondary outcome measures include: Quality of life, treatment satisfaction, and alcohol dependency as measured by the Alcohol Use Disorders Identification Test (AUDIT).
- TimepointsMeasurement waves will take place at baseline and 3, 6, and 12 months post-randomisation.
- Trial web
- statusopen: patient inclusion
- 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 alcohol moderation internet intervention in a sample of alcohol misusing cancer survivors, in comparison to a control condition (internet-based information brochure on alcohol).
- 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 is the last 10 years

Delete the following inclusion criterium: Alcohol Use Disorders Identification Test (AUDIT) score < 20

Blinding: single -> none
- RECORD1-sep-2016 - 15-jul-2017

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