No registrations found.
ID
Source
Brief title
Health condition
Cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quality of life and healthcare utilization
Secondary outcome
Lifestyle behavior, comorbidity and cancer recurrence
Background summary
Many observational studies have shown an association between a healthy lifestyle and a lower risk of cancer recurrence. However, in daily care little or no attention is paid to the lifestyle of cancer patients. Only 40% of the Dutch cancer patients meet the daily exercise norm of 30 minutes a day, and only 10 % of the patients meet the World Cancer Research guidelines for the consumption of meat, vegetables and fruit. Less than 20% of the patients indicate they receive nutritional advice. There is a considerable room for improvement of lifestyle medicine.
However, there is a lack of proven effective lifestyle programs for cancer patients. In this intervention study, 250 colon cancer patients and bladder cancer patients will be offered a lifestyle program after completion of treatment with curative intent. Their outcomes will be compared with at least 750 patients receiving usual care. The lifestyle program covers 24 months: the first 3 months of intensive counseling in small groups and 21 months of aftercare. During this program, attention is paid to exercise, nutrition, relaxation and sleep.
Outcomes will be measured at baseline and after 3, 12 and 24 months. Outcomes will be quality of life, healthcare utilization, lifestyle behavior, comorbidity and cancer recurrence.
Study objective
The lifestyle program will improve the quality of life and lifestyle behavior, and will decrease the healthcare utlization, comorbidity and cancer recurrence rates.
Study design
Baseline (before start lifestyle program), 3, 12 and 24 months
Intervention
Lifestyle program offered by Stichting Voeding Leeft
Inclusion criteria
Colorectal cancer (stage I-III) and bladder cancer patients (stage Ta, I-III), completed primary treatment with curative intent (radiotherapy, chirurgy and chemotherapy; except for intravesical instillations in non-muscle invasive bladder cancer which are allowed during the intervantion), age: 18-75 year
Exclusion criteria
Not able to participate in the lifestyle program because of severe comordity (e.g. COPD, heart failure, mental health problems), diabetic patients using insuline
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9558 |
| Other | METC Arnhem-Nijmegen has concluded that the study does not fall under the WMO (Law on medical experimentation) : 2021-7305 |