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Assessment of Health Related Quality of Life in Patients Treated for Rectal Cancer

This study has been terminated.
(unknown)
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00532987
First received: September 20, 2007
Last updated: February 24, 2012
Last verified: February 2012

September 20, 2007
February 24, 2012
December 2003
September 2009   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00532987 on ClinicalTrials.gov Archive Site
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Assessment of Health Related Quality of Life in Patients Treated for Rectal Cancer
Assessment of Health Related Quality of Life in Patients Treated for Rectal Cancer

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

History of histologically-confirmed rectal cancer with treatment or undergoing treatment at Stanford University Hospital.

  • Rectal Cancer
  • Colon Cancer
  • Anal Cancer
Behavioral: Questionnaire
Questionnaire form to be completed by patient
Other Name: Research survey
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
22
September 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:History of histologically-confirmed rectal cancer with treatment or undergoing treatment at Stanford University Hospital.

Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00532987
REC0003, 79517, REC0003
Yes
Stanford University
Stanford University
Not Provided
Principal Investigator: Mark Lane Welton Stanford University
Stanford University
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP