Rectal CancerNCT01181557
A Questionnaire to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma
An observational study of Rectal Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
Trial summary
The aim of the present prospective study was to evaluate the prediction accuracy of EORTC QLQ-C30/C38 questionnaire in rectal cancer patient(RC). This study was designed to investigate how the quality of life (QoL) of patients with rectal cancer changes with time after cancer or after stomia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rectal Cancer
- How many people
- 236 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2008to Dec 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients admitted to hospital for rectal cancer, Italian resident older than 18 years, without history of psychiatric illness, or preoperative radiotherapy, dived in two cohorts patient with stoma after surgery and patients without stoma after surgery
Who may be able to join
- Rectal cancer
Who cannot join
- Age younger than 18 years
- History of psychiatric illness
- Preoperative radiotherapy
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Milan, Italy, 20133
About this study
Official title: Prospective Evaluation of Quality of Life in Patient With Rectal Cancer
The aim of the present prospective study was to evaluate the prediction accuracy of EORTC QLQ-C30/C38 questionnaire in rectal cancer patient(RC). This study was designed to investigate how the quality of life (QoL) of patients with rectal cancer changes with time after cancer or after stomia.
Eligible subjects were consecutively enrolled in the investigators' Institute and subjected to EORTC QLQ-C30/C38 questionnaire.
Read the detailed description
Eligibility criteria: Italian people with adenocarcinoma of rectum. Exclusion criteria consisted of age younger than 18 years, history of psychiatric illness, and preoperative radiotherapy.
Outcome measures: patient was carried out using a EORTC QLQ-C30/C38 questionnaire.To determine how surgery affects QoL, we divided patients into two groups: first rectal cancer submitted to rectal anterior resection(RAR) and latter rectal cancer submitted to rectal anterior resection with stomia(RARS). Differences in QoL between the two groups were analyzed during three time: first preoperative, second postoperative and latter six month later of after the stoma reconversion in RARS patients
- Conditions
- Rectal Cancer
- Keywords
- quality of life
- Medical subject headings
- Rectal 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 |
|---|---|---|
| rectal cancer with stoma | rectal cancer submitted to rectal anterior resection with stomia (RARS). Differences in QoL between the two groups were analyzed during three time: first preoperative, second postoperative and latter six month after stoma reconversion | |
| rectal cancer without stoma | rectal cancer submitted to rectal anterior resection (RAR) Differences in QoL between the two groups were analyzed during three time: first preoperative, second postoperative and latter six month later | |
| anterior resection of rectum | patients with rectal cancer submitted to RAR and patients with rectal cancer submitted to RARS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire number 1, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma
Two cohort in preoperative time: first EORTC QLQ-C30/C38 questionnaire in rectal cancer submitted to RAR and latter in rectal cancer submitted to RARS.
Measured: three month: first admission in hospital preoperative time
Secondary outcomes (2)
Questionnaire number 2, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma
Two cohort in postoperative time (three months after surgical procedure): first EORTC QLQ-C30/C38 questionnaire in rectal cancer submitted to RAR and latter in rectal cancer submitted to RARS.
Measured: Three months postoperative time
Questionnaire number 3, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma
Two cohort in postoperative time (six months after postoperative time): first EORTC QLQ-C30/C38 questionnaire in rectal cancer submitted to RAR and latter in rectal cancer submitted to RARS.
Measured: Six months after postoperative time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study startSep 2008
- Primary completionAug 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe sponsor's other registered studies.
- 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
- 236 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- alberto vannelli, MD, Study director, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181557
- Sponsor's protocol ID
- INT-D176768
- Status last verified
- Jul 2008
- First submitted
- 1 Apr 2010
- Last updated
- 13 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Quality of Life in Patient With Rectal Cancer
- ClinicalTrials.gov ID
- NCT01181557
- Acronym / sponsor ID
- INT-D176768
- Conditions
- Rectal Cancer
- Keywords
- quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 13 Aug 2010 (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.
The aim of the present prospective study was to evaluate the prediction accuracy of EORTC QLQ-C30/C38 questionnaire in rectal cancer patient(RC). This study was designed to investigate how the quality of life (QoL) of patients with rectal cancer changes with time after cancer or after stomia.
Eligible subjects were consecutively enrolled in the investigators' Institute and subjected to EORTC QLQ-C30/C38 questionnaire.
Detailed description
Eligibility criteria: Italian people with adenocarcinoma of rectum. Exclusion criteria consisted of age younger than 18 years, history of psychiatric illness, and preoperative radiotherapy.
Outcome measures: patient was carried out using a EORTC QLQ-C30/C38 questionnaire.To determine how surgery affects QoL, we divided patients into two groups: first rectal cancer submitted to rectal anterior resection(RAR) and latter rectal cancer submitted to rectal anterior resection with stomia(RARS). Differences in QoL between the two groups were analyzed during three time: first preoperative, second postoperative and latter six month later of after the stoma reconversion in RARS patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| rectal cancer with stoma | – | –rectal cancer submitted to rectal anterior resection with stomia (RARS). Differences in QoL between the two groups were analyzed during three time: first preoperative, second postoperative and latter six month after stoma reconversion |
| rectal cancer without stoma | – | –rectal cancer submitted to rectal anterior resection (RAR) Differences in QoL between the two groups were analyzed during three time: first preoperative, second postoperative and latter six month later |
| anterior resection of rectum | – | –patients with rectal cancer submitted to RAR and patients with rectal cancer submitted to RARS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to hospital for rectal cancer, Italian resident older than 18 years, without history of psychiatric illness, or preoperative radiotherapy, dived in two cohorts patient with stoma after surgery and patients without stoma after surgery
Key inclusion criteria (1 listed)
- Rectal cancer
Key exclusion criteria (3 listed)
- Age younger than 18 years
- History of psychiatric illness
- Preoperative radiotherapy
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
Questionnaire number 1, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma
Time frame: three month: first admission in hospital preoperative time
Two cohort in preoperative time: first EORTC QLQ-C30/C38 questionnaire in rectal cancer submitted to RAR and latter in rectal cancer submitted to RARS.
2 secondary outcomes
Questionnaire number 2, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma
Time frame: Three months postoperative time
Questionnaire number 3, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma
Time frame: Six months after postoperative time
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 13 Aug 2010.
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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.
alberto vannelli, MD study director
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
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 1 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 13 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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.
What does the primary outcome measure?
Questionnaire number 1, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma (time frame: three month: first admission in hospital preoperative time). It is what the study was designed to measure, not a finding.
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 13 Aug 2010.