Rectal CancerNCT00532987
Assessment of Health Related Quality of Life in Patients Treated for Rectal Cancer
An observational study of Rectal Cancer and Colon Cancer, run by Stanford University at 1 site in United States.
Trial summary
Treatment of rectal cancer often consists of surgical resection of the tumor. Chemotherapy and/or radiotherapy are frequently given before or after surgery. In this study, we wish to learn if there are differences in the treatment effectiveness or in the quality of life of patients based on their type of treatment… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Rectal Cancer, Colon Cancer, Anal Cancer
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Sep 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: History of histologically-confirmed rectal cancer with treatment or undergoing treatment at Stanford University Hospital.
Inclusion Criteria:History of histologically-confirmed rectal cancer with treatment or undergoing treatment at Stanford University Hospital.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Treatment of rectal cancer often consists of surgical resection of the tumor. Chemotherapy and/or radiotherapy are frequently given before or after surgery. In this study, we wish to learn if there are differences in the treatment effectiveness or in the quality of life of patients based on their type of treatment (e.g. Radiotherapy and chemotherapy before or after surgery). Information from this questionnaire collected from you and other patients may help improve the quality of life of rectal cancer patients in the future. Medical information on your tumor, treatment received, and side effects will be compiled and maintained in a database to learn more about outcomes of treatment for rectal cancer.
Read the detailed description
There exists little published data studying the health related quality of life (HRQOL) of patients treated for the rectal cancer. Patients are commonly treated with surgery preceded or followed by chemo radiotherapy. Patients chart review and questionnaires administered during follow-up exam or by mailing will be use to compile data comparing the HRQOL of the two study groups(Preoperative versus Post operative chemotherapy).
Our Radiation Oncologist will also informed all the new pts. under going radiotherapy regarding this study and will encourage them in become part of our study population. The prospective study will help us in increasing the number of participants and also it give us an opportunity following the patients as they go through their treatment.
Through the use of department databases, a cohort or rectal cancer patients treated at Stanford will be identified. Patients demographics, treatment received ,disease outcomes, and treatment associated complications will be compiled from available data. HRQOL questionnaires will be answered through a mailing or during clinic visits. Treatment outcomes, toxicities and overall quality of life of preoperative and postoperative chemo radiotherapy treatment group will be compared in relation to the lesion location.
- Conditions
- Rectal Cancer, Colon Cancer, Anal Cancer
- Being tested
- Questionnaire
- Medical subject headings
- Rectal Neoplasms, Colonic Neoplasms, Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Research survey
Questionnaire form to be completed by patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2007 (estimated)
- Study startDec 2003
- Primary completionSep 2009
- Study completionSep 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 Stanford UniversityThe 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Lane Welton, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00532987
- Sponsor's protocol ID
- REC0003
- Other IDs
- 79517, REC0003
- Status last verified
- Feb 2012
- First submitted
- 20 Sep 2007
- Last updated
- 28 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Health Related Quality of Life in Patients Treated for Rectal Cancer
- ClinicalTrials.gov ID
- NCT00532987
- Acronym / sponsor ID
- REC0003
- Conditions
- Rectal Cancer, Colon Cancer, Anal Cancer
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Dec 2003
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 21 Sep 2007 (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.
Treatment of rectal cancer often consists of surgical resection of the tumor. Chemotherapy and/or radiotherapy are frequently given before or after surgery. In this study, we wish to learn if there are differences in the treatment effectiveness or in the quality of life of patients based on their type of treatment (e.g. Radiotherapy and chemotherapy before or after surgery). Information from this questionnaire collected from you and other patients may help improve the quality of life of rectal cancer patients in the future. Medical information on your tumor, treatment received, and side effects will be compiled and maintained in a database to learn more about outcomes of treatment for rectal cancer.
Detailed description
There exists little published data studying the health related quality of life (HRQOL) of patients treated for the rectal cancer. Patients are commonly treated with surgery preceded or followed by chemo radiotherapy. Patients chart review and questionnaires administered during follow-up exam or by mailing will be use to compile data comparing the HRQOL of the two study groups(Preoperative versus Post operative chemotherapy).
Our Radiation Oncologist will also informed all the new pts. under going radiotherapy regarding this study and will encourage them in become part of our study population. The prospective study will help us in increasing the number of participants and also it give us an opportunity following the patients as they go through their treatment.
Through the use of department databases, a cohort or rectal cancer patients treated at Stanford will be identified. Patients demographics, treatment received ,disease outcomes, and treatment associated complications will be compiled from available data. HRQOL questionnaires will be answered through a mailing or during clinic visits. Treatment outcomes, toxicities and overall quality of life of preoperative and postoperative chemo radiotherapy treatment group will be compared in relation to the lesion location.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- History of histologically-confirmed rectal cancer with treatment or undergoing treatment at Stanford University Hospital.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAlso: Research surveyQuestionnaire form to be completed by patient | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2012.
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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.
Mark Lane Welton principal investigator
Stanford University
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 and Colon Cancer, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 28 Feb 2012. 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 United States. 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 was stopped early. Results are not available in the source record.
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 28 Feb 2012.