Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-28 @ 12:09 AM
Study NCT ID:
NCT01303393
Status:
COMPLETED
Last Update Posted:
2011-02-24
First Post:
2011-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Information Needs After Surgery for Colorectal Cancer
Sponsor:
Region Skane
Organization:
Study Overview
Official Title:
Information Needs After Surgery for Colorectal Cancer - From the Perspective of the Patient and Next of Kin
Status:
COMPLETED
Status Verified Date:
2011-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: