Information Needs After Surgery for Colorectal Cancer
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| First Received Date ICMJE | February 23, 2011 | ||||
| Last Updated Date | February 23, 2011 | ||||
| Start Date ICMJE | January 2007 | ||||
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Information needs - patients' and next of kins' [ Time Frame: 7 weeks ] [ Designated as safety issue: No ] In the interviews with patients and next of kins separately they are asked to express their needs for information at that time. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Information Needs After Surgery for Colorectal Cancer | ||||
| Official Title ICMJE | Information Needs After Surgery for Colorectal Cancer - From the Perspective of the Patient and Next of Kin | ||||
| Brief Summary | Aim The overall aim was to investigate information needs after surgery for colorectal cancer and factors explaining information needs, both from the patients' perspective and the next of kin's. |
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| Detailed Description | Sample Inclusion criteria are patients over 18 years of age that have gone through a surgery for colorectal cancer without having a stoma, and their next of kin with whom they live. Instruments In study I, 100 patients filled in four different instruments 1-2 weeks after discharge to measure: QOL, information needs, sense of coherence and performance status. QLQ-C30 and QLQ-CR38 were used to measure QOL. INFO26 were used to measure received information. The SOC - Sense of Coherence was used to measure sense of coherence. And finally the scale for ECOG Performance Status was used to measure the level of physical performance status. In study II the same patients filled in the same instruments a second time, 5-7 week after discharge. Information about marital status, occupation, diagnosis and prognosis were taken from the medical record. Interviews In study III 16 patients both filled in the instruments in study I and II, and were interviewed to gain a deeper understanding of their information needs. The interviews were semi structured and will be analysed with content analysis. In study IV the next of kin to patients in study III were interviewed about their own information needs in connection to discharge. The interviews were performed twice for each person, 1-2 weeks after discharge and a second time, 5-7 week after discharge. Data sampling The data were collected consecutively, and every third patient living together with their next of kin were asked to participate in the interviews. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Inclusion criteria are patients over 18 years of age that have had a surgery for colorectal cancer without having a stoma, and their next of kin with whom they live. They should be able to speak and read Swedish. |
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| Condition ICMJE | Colorectal Cancer | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Surgery for colorectal cancer
Patients that had surgery for colorectal cancer without receiving a stoma, and their next of kin. |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 100 | ||||
| Completion Date | August 2009 | ||||
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Sweden | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01303393 | ||||
| Other Study ID Numbers ICMJE | Etics review Dnr 558/2006 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Jan Johansson, MD, Associate professor, Dpt of Surgery, Lund University, Sweden | ||||
| Study Sponsor ICMJE | Region Skane | ||||
| Collaborators ICMJE | Lund University | ||||
| Investigators ICMJE |
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| Information Provided By | Region Skane | ||||
| Verification Date | February 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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