Colorectal CancerNCT01303393
Information Needs After Surgery for Colorectal Cancer
An observational study of Colorectal Cancer, run by Region Skane at 3 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 100 participants
- Where
- 3 sitesSweden
- Study dates
- Jan 2007to Aug 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- receiving a stoma
- don't want to participate
- not completed at least half of the items in both questionnaires
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Surgical clinic
Helsingborg, Skåne County, 25187
Surgical clinic
Lund, Skåne County, 22185
Surgical clinic
Malmö, Skåne County, 20502
About this study
Official title: Information Needs After Surgery for Colorectal Cancer - From the Perspective of the Patient and Next of Kin
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.
Read the 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.
- Conditions
- Colorectal Cancer
- Keywords
- Patient education. Patient discharge. Needs assessment.
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surgery for colorectal cancer | Patients that had surgery for colorectal cancer without receiving a stoma, and their next of kin. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startJan 2007
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Investigators
- Maria Lithner, RN, Principal investigator, Surgical clinic, Lund, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303393
- Sponsor's protocol ID
- Etics review Dnr 558/2006
- Status last verified
- Feb 2011
- First submitted
- 23 Feb 2011
- Last updated
- 24 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Information Needs After Surgery for Colorectal Cancer - From the Perspective of the Patient and Next of Kin
- ClinicalTrials.gov ID
- NCT01303393
- Acronym / sponsor ID
- Etics review Dnr 558/2006
- Conditions
- Colorectal Cancer
- Keywords
- Patient education. Patient discharge. Needs assessment.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- Jan 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 24 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery for colorectal cancer | – | –Patients that had surgery for colorectal cancer without receiving a stoma, and their next of kin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- receiving a stoma
- don't want to participate
- not completed at least half of the items in both questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
1 secondary outcome
Information needs - patients' and next of kins'
Time frame: 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Lithner, RN principal investigator
Surgical clinic, Lund, Sweden
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Region Skane at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2011.