- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01303393
Information Needs After Surgery for Colorectal Cancer
Information Needs After Surgery for Colorectal Cancer - From the Perspective of the Patient and Next of Kin
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Skåne
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Helsingborg, Skåne, Sweden, 25187
- Surgical clinic
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Lund, Skåne, Sweden, 22185
- Surgical clinic
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Malmö, Skåne, Sweden, 20502
- Surgical clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- adult over 18 years of age
- surgery for colorectal cancer in one of the three hospitals in the study
- speak and read Swedish
- be able to understand the instructions written in the questionnaires
Exclusion Criteria:
- receiving a stoma
- don't want to participate
- not completed at least half of the items in both questionnaires
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Surgery for colorectal cancer
Patients that had surgery for colorectal cancer without receiving a stoma, and their next of kin.
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What is the study measuring?
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Information needs - patients' and next of kins'
Time Frame: 7 weeks
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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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7 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Maria Lithner, RN, Surgical clinic, Lund, Sweden
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Etics review Dnr 558/2006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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