Information Needs After Surgery for Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Information Needs After Surgery for Colorectal Cancer - From the Perspective of the Patient and Next of Kin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01303393
• Other study ID #: Etics review Dnr 558/2006
• Status: Completed
• Phase: N/A
• First received: February 23, 2011
• Last updated: February 23, 2011
• Start date: January 2007
• Est. completion date: August 2009

Study information

• Verified date: February 2011
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
Sweden	Surgical clinic	Helsingborg	Skåne
Sweden	Surgical clinic	Lund	Skåne
Sweden	Surgical clinic	Malmö	Skåne

Sponsors (2)

Lead Sponsor	Collaborator
Region Skane	Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Secondary	Information needs - patients' and next of kins'	In the interviews with patients and next of kins separately they are asked to express their needs for information at that time.	7 weeks	No