|- candidate number||21672|
|- NTR Number||NTR5196|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-feb-2015|
|- Secondary IDs||2014-1177 |
|- Public Title||Effect of health promotion materials on awareness of and adherence to WCRF/AICR cancer prevention recommendations among Lynch Syndrome carriers|
|- Scientific Title||Effect of WCRF-NL health promotion materials on awareness of and adherence to WCRF/AICR cancer prevention recommendations among Lynch Syndrome carriers
|- ACRONYM||Lifestyle & Lynch (LiLy)|
|- Healt Condition(s) or Problem(s) studied||Lynch syndrome|
|- Inclusion criteria|| Lynch syndrome carriers who have been tested during the last 6 years|
Between18-65 years old
Able to read, write and communicate in Dutch.
|- Exclusion criteria|| Participation in the GeoLynch study from Wageningen University|
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2015|
|- planned closingdate||30-jun-2016|
|- Target number of participants||230|
|- Interventions||The intervention group will receive one-time printed WCRF health promotion materials between the fist en second measurement, while the control group will receive these health promotion materials after finishing the last measurement. The materials include one general leaflet, which first explains the development of cancer and the different ways of prevention. After that, it continues with an explanation of each of the 10 WCRF/AICR cancer prevention recommendations: (1) Be as lean as possible without becoming underweight, (2) be physically active for at least 30 minutes every day, (3) limit consumption of energy-dense foods and avoid sugary drinks (4) eat more of a variety of vegetables, fruits, whole grains and legumes such as beans, (5) limit consumption of red meats (such as beef, pork and lamb) and avoid processed meats (6) if consumed at all, limit alcoholic drinks to 2 for men and 1 for women a day (7) limit consumption of salty foods and foods processed with salt (sodium), (8) don't use supplements to protect against cancer, (9) it is best for mothers to breastfeed exclusively for up to 6 months and then add other liquids and foods, and (10) after treatment, cancer survivors should follow the recommendations for cancer prevention. |
The second leaflet is specially focusing on recommendations for the prevention of colorectal cancer. First, it explains colorectal cancer, its development and first signs. After that, it continues with describing risk factors for colorectal cancer and explains in more detail the lifestyle recommendation which have been related to a reduced risk of colorectal cancer.
|- Primary outcome||Awareness will be measured using the question from the AICR Cancer Risk Awareness Survey Do the following factors have a significant effect on whether or not the average person develops cancer? with respect to the exposures (1) overweight, (2) insufficient physical activity, (3) diets low in vegetables and fruits, (4) diets high in red meat, (5) cured / processed meats, (6) alcohol, and (7) smoking. Other non-related factors are added to this list.|
|- Secondary outcome||Adherence to the WCRF/AICR recommendations: WCRF/AICR score, including:
- Dietary behavior: Adapted version of a short, validated questionnaire (FFQ) specifically developed to assess adherence to the WCRF recommendation for cancer prevention. |
- Physical activity behavior: Short Questionnaire to Assess Health Enhancing Physical Activity (SQUASH)
- Smoking behavior: Standardized questions concerning age or date of starting/stopping smoking, current smoking, number of cigarettes smoked per day, and duration of smoking.
- Anthropometric measurements: self-reported weight, height and waist-hip circumference.
Determinants of adherence to recommendations for cancer prevention:
- Health Belief Model concepts: A self-developed questionnaire adapted from existing HBM questionnaires.
- Stages of Change from the Transtheoretical model of change: a questionnaire adapted from existing stages of change questionnaires.
- Other determinants derived from the focus groups (e.g., enjoy life, colon surgery, habit, receiving regular colon screening).
Perceived and actual cancer risk:
Details on actual risk will be obtained from medical records.
Cancer risk perception will be assessed by two standardized questions.
Cancer worry: The cancer worry scale.
Distress: The Dutch version of the Hospital Anxiety and Depression Scale (HADS)
Satisfaction with and the use of the WCRF education materials and other educational materials
|- Timepoints||Participants will fill out online or paper questionnaires at three time points: at baseline (T0), 4 weeks (T1) and 6 months afterwards (T2). Two weeks after T0 the intervention group receives the WCRF-NL health promotion materials. |
The effects of WCRF-NL health promotion materials on primary and secondary outcomes will be evaluated at T1 and T2 and will be compared to T0, as well as to the scores of the control group at these time points.
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Msc Annemiek Visser |
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. Ellen Kampman|
|- Sponsor/Initiator ||Radboud University Medical Center, Department for Health Evidence|
(Source(s) of Monetary or Material Support)
|World Cancer Research Fund |
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||11-feb-2015 - 25-jul-2015|