Improving Care After colon canceR treatment in the Netherlands- Personalised care to Enhance quality of life
- Conditions
- Colon cancer
- Registration Number
- NL-OMON20048
- Lead Sponsor
- Academisch Medisch Centrum Amsterdam
- Brief Summary
Trials. 2015 Jun 26;16:284. doi: 10.1186/s13063-015-0798-7. Improving care after colon cancer treatment in The Netherlands, personalised care to enhance quality of life (I CARE study): study protocol for a randomised controlled trial. Duineveld LA1, Wieldraaijer T2, van Asselt KM3, Nugteren IC4, Donkervoort SC5, van de Ven AW6, Smits AB7, van Geloven AA8, Bemelman WA9, Beverdam FH10, van Tets WF11, Govaert MJ12, Bosmans JE13, Verdonck-de Leeuw IM14, van Uden-Kraan CF15, van Weert HC16, Wind J17
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 300
•Carcinoma located in the colon and rectosigmoid defined as a tumour located 15 cm above the anal verge by coloscopy or above the sacral promontory as seen preoperatively
•Stage 1, 2 and 3 carcinoma
•Stage IV colorectal tumours
•Hereditary colorectal cancer
Study & Design
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quality of life (generic and disease specific)
- Secondary Outcome Measures
Name Time Method 1) Physical outcomes: Recurrence rate and mortality, presence and duration of cancer related physical problems (pain, bowel function, fatigue, sexual problems, adverse side-effects of chemotherapy, et cetera), number, sort and treatment of intercurrent signs and symptoms.<br><br /><br /><br>2) Psychosocial outcomes: Labour force participation, participation and experienced autonomy, emotional support, anxiety, depression and self-efficacy.<br><br /><br /><br>3) Number of diagnostic tests, referrals and related communication between secondary and primary care<br><br /><br /><br>4) Recurrence detection and protocol adherence <br><br /><br /><br>5) Attention to preventive care (change in smoking habits, physical activity, mean systolic blood pressure, and cholesterol levels)<br><br /><br /><br>6) Cost effectiveness<br><br /><br /><br>7) Patient satisfaction and preference of care at the end of the trial<br>