Information Needs After Surgery for Colorectal Cancer

This study has been completed.
Sponsor:
Collaborator:
Lund University
Information provided by:
Region Skane
ClinicalTrials.gov Identifier:
NCT01303393
First received: February 23, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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.


Condition
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Information Needs After Surgery for Colorectal Cancer - From the Perspective of the Patient and Next of Kin

Resource links provided by NLM:


Further study details as provided by Region Skane:

Secondary Outcome Measures:
  • 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.


Enrollment: 100
Study Start Date: January 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Surgery for colorectal cancer
Patients that had surgery for colorectal cancer without receiving a stoma, and their next of kin.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01303393

Locations
Sweden
Surgical clinic
Helsingborg, Skåne, Sweden, 25187
Surgical clinic
Lund, Skåne, Sweden, 22185
Surgical clinic
Malmö, Skåne, Sweden, 20502
Sponsors and Collaborators
Region Skane
Lund University
Investigators
Principal Investigator: Maria Lithner, RN Surgical clinic, Lund, Sweden
  More Information

No publications provided

Responsible Party: Jan Johansson, MD, Associate professor, Dpt of Surgery, Lund University, Sweden
ClinicalTrials.gov Identifier: NCT01303393     History of Changes
Other Study ID Numbers: Etics review Dnr 558/2006
Study First Received: February 23, 2011
Last Updated: February 23, 2011
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Region Skane:
Patient education. Patient discharge. Needs assessment.

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on April 17, 2014