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Assessment of Health Related Quality of Life in Patients Treated for Rectal Cancer
This study is currently recruiting participants.
Verified by Stanford University, July 2008
Sponsored by: Stanford University
Information provided by: Stanford University
ClinicalTrials.gov Identifier: NCT00532987
  Purpose

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.


Condition Intervention
Rectal Cancer
Behavioral: Questionnaire

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Observational
Official Title: Assessment of Health Related Quality of Life in Patients Treated for Rectal Cancer

Further study details as provided by Stanford University:

Estimated Enrollment: 300
Study Start Date: December 2003
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 indentified. 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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00532987

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Moe Jalali     650-724-4023     moej@stanford.edu    
Contact: Cancer Clinical Trials Office     (650) 498-7061        
Principal Investigator: Mark Lane Welton            
Sub-Investigator: George Albert Fisher M.D. Ph.D.            
Sub-Investigator: James M Ford            
Sub-Investigator: Albert Koong            
Sub-Investigator: Dr Andrew Shelton            
Sub-Investigator: Scott Soltys            
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Mark Lane Welton Stanford University
  More Information

Study ID Numbers: REC0003, 79517, NCT00532987, REC0003
Study First Received: September 20, 2007
Last Updated: July 2, 2008
ClinicalTrials.gov Identifier: NCT00532987  
Health Authority: United States: Food and Drug Administration;   United States: Institutional Review Board

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Rectal Neoplasms
Quality of Life
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal cancer
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms
Rectal neoplasm

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009