Link to other cohort descriptions
Contact person(s) for the study description
Anne Tjønneland and Rikke Dalgaard Hansen
Partner
Institute
Unit of Diet, Genes & Environment, Danish Cancer Society Research Center, Copenhagen, Denmark.
Key personnel for CHANCES
Responsible persons: Anne Tjønneland, Rikke Dalgaard Hansen
Definition of the study
The aim was to investigate the feasibility of a behavioral lifestyle intervention including vigorous physical activity combined with a health-promoting diet with high intake of whole grain rye among elderly men with prostate cancer in an early stage: To investigate the compliance with intervention prescriptions, to test if the study design is applicaple for the participants in their every day life, and to polish off the study design in order to make it as efficient as possible for the research team. Additionally, we explored drop out reasons and level among control group members and whether or not the men assigned to the control group changed their lifestyle towards more exercise and healthy diet (the control group members were not informed of the exact intervention prescriptions but knew of the parameters whole grain rye and exercise).
For further study description, see www.clinicaltrials.gov NCT 01300104.
Target population
We enrolled 24 Danish men with early-stage prostate cancer and on active surveillance to a feasibility study.
Enrolment was initiated January 2010.
Recruitment
In the feasibility study, the prostate cancer patients are referred to the project coordinator from a clinical center of urology. The eligibility criteria are to be diagnosed with early-stage prostate cancer and on active surveillance for cancer progression, to be able and willing to participate fully in the intervention with no conditions or behaviors likely to affect the intervention (e.g. vegetarian, medical conditions, underlying diseases or physical constitution not suitable for intervention). The participants have no prior history of cancer, except for non-melanoma skin cancer, and have more than 3 years of life expectancy.
Years of recruitment
As long as it takes to enroll 24 eligible men with prostate cancer, or max 12 months. Recruitment of participants was continuous as men were diagnosed with early-stage prostate cancer.
Size of the study
24 early-stage prostate cancer patients on active surveillance. The intervention Group included 16 men, the control Group included 8 men.
Measurements at baseline and recontacts
The feasibility study is initiated with Collection of the following data and biological samples: clinical (height, weight, hip and waist circumference, oral glucose tolerance test, fasting blood samples, 24h-urine samples and prostate tissue samples), a questionnaire on diet, lifestyle, health, occupation etc. as well as measurements of fitness (maximal oxygen consumption) and muscle strength.
These measurements will be repeated after 3 months, 6 months (after the intervention) and at 12 months (end of follow-up), except for the prostate tissue samples that are collected only at baseline and approximately six months after baseline. Furthermore, dietary advice will be given in week 2 and 6 of the intervention. See attached project description for study design of the feasibility study.
| Socioeconomic | Baseline |
|---|---|
| Education | Yes |
| Income | No |
| Marital status | Yes |
| Occupation | No |
| Employment status | Yes |
| History of | Baseline |
| Diabetes | Yes |
| Dyslipidemia | No, but hypercholesterolemia |
| Coronary heart disease | No |
| Stroke | No |
| Cancer | Yes |
| Benign neoplasms | No |
| Fracture | No |
| - Which site(s)? | - |
| Osteoporosis | No |
| Family history of | Baseline |
| Coronary heart disease | No |
| Stroke | No |
| Diabetes | No |
| Cancer | No |
| Lifestyle | Baseline |
| Current smoking | Yes |
| Past smoking | Yes |
| Alcohol use | Yes |
| Physical activity | Yes |
| Nutrition (yes/no) | Yes |
| - Number of food items available (approximately) | |
| - Method(s) of dietary assessment (e.g. 24h-recall, food frequency questionnaire, dietary records) | FFQ on selected items |
| - Supplement use | Yes |
| Anthropometry | Baseline |
| Weight and height | Yes |
| - Measured or self-reported | Both |
| Unintended weight loss | No |
| Waist circumference | Yes |
| - Measured or self-reported | Both |
| Hip circumference | Yes |
| Measured or self-reported | Both |
| Blood pressure | Baseline |
| Measured blood pressure | Yes |
| History of hypertension | Yes |
| Blood tests | Baseline |
| Total cholesterol | Yes |
| HDL cholesterol | Yes |
| Triglycerides | Yes |
| - Fasting period | Yes |
| ApoA1 | No |
| ApoB | No |
| Glucose | Yes |
| - Fasting period | Yes |
| Glucose tolerance test | Yes |
| HbA1c | Yes |
| GGT | No |
| CRP | Yes |
| 25-Hydroxy-Vitamin D | No |
| Other tests (specify) | Metabolomics |
| Availability of frozen sera for further analysis | Yes |
| - Storage temperature (°C) of sera | -142 |
| Availability of frozen plasma for further analysis | Yes |
| - Storage temperature (°C) of plasma | -142 |
| Genetics | Baseline |
| Genotypic data | No |
| GWAS (specify) | No |
| Other high-throughput array data (specify) | No |
| Availability of DNA for further genotyping | No |
| Plated DNA | No |
| Otherwise stored DNA | No |
| Other measurements | Baseline |
| Perceived health | Yes |
| Cognitive decline/dementia | No |
| Depression | No |
| Grip Strength | No |
| Lung function | No |
| Audiometry | No |
| Measurement of bone density (DEXA) | No |
| Quality of life instruments (such as SF-12, EUROQoL) | No |
| Limitations in ADL/IADL (i.e. Activities of daily living/Instrumental activities of daily living) | No |
| Multimorbidity instruments (such as CIRS-G) | No |
| Frailty scales | No |
| Reproductive history (for women) | - |
| Menstruation and menopausal status | - |
| Fertility problems | - |
| Pregnancies | - |
| Breast feeding | - |
| Hysterectomy and ovariectomy | - |
| History of oral contraceptive use | - |
| History of menopausal hormones use | - |
| Current use of exogenous hormones | - |
| Use of drugs | Yes, pain relievers |
| Availability of classification of drugs, specify (e.g. Anatomical Therapeutic Chemical(ATC) classification system) | - |
| Additional Topics | Baseline |
| Smoking history | |
| Alcohol history | |
| Treatment for diabetes, hypercholesterolemia, hypertension | |
| Weight history | |
| General health (at baseline and one year before) | |
| Contacts and social activity |
Future recontacts
After 2 and 6 weeks of intervention - dietary advice
After 3, 6 and 12 months - clinical measures, assessment of diet and fitness, dietary and exercise advices, Collection of biological material.
Other follow-up
Follow-up period
12 months after baseline
Sources of data
Questionnaire, Measurement of anthropometrics, muscle strength, fitness and Laboratory analysis of biological material.
Follow-up procedure
No further follow-up planned for the feasibility study.
End-points covered through the follow-up
- All deaths: No
- Non-fatal cancers: No
- Cancer survival: No
- Non-fatal acute coronary events: No
- Non-fatal stroke: No
- Non-fatal diabetes: No
- Fractures: No
- Cognitive impairment/dementia: No
- Nursing home admission: No
- Primary end-points: Feasibility of intervention
