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

• ClinicalTrials.gov Identifier: NCT00532987
• Recruitment Status: Terminated
• First Posted: September 21, 2007
• Last Update Posted: February 28, 2012
• Sponsor: Stanford University
• Information provided by (Responsible Party): Stanford University

Tracking Information

• First Submitted Date: September 20, 2007
• First Posted Date: September 21, 2007
• Last Update Posted Date: February 28, 2012
• Study Start Date: December 2003
• Actual Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Assessment of Health Related Quality of Life in Patients Treated for Rectal Cancer
• Official Title: Assessment of Health Related Quality of Life in Patients Treated for Rectal Cancer
• Brief 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 (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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: History of histologically-confirmed rectal cancer with treatment or undergoing treatment at Stanford University Hospital.

Condition

• Rectal Cancer
• Colon Cancer
• Anal Cancer

Intervention

Behavioral: Questionnaire

Questionnaire form to be completed by patient

Other Name: Research survey

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: February 24, 2012): 22
• Original Estimated Enrollment (submitted: September 20, 2007): 300
• Actual Study Completion Date: September 2009
• Actual Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
• Eligibility Criteria: Inclusion Criteria:History of histologically-confirmed rectal cancer with treatment or undergoing treatment at Stanford University Hospital.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00532987
• Other Study ID Numbers: REC0003; 79517 ( Other Identifier: Stanford University Alternate IRB Approval Number ); REC0003 ( Other Identifier: Stanford University )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Stanford University
• Original Responsible Party: Not Provided
• Current Study Sponsor: Stanford University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Mark Lane Welton; Stanford University

• PRS Account: Stanford University
• Verification Date: February 2012