Status:
ACTIVE_NOT_RECRUITING
Relationship Between Quality of Life, Treatment Modalities, and Patient Treatment/Outcome Expectations
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Rectal Cancer
Eligibility:
All Genders
Brief Summary
The goal of this study is to learn how the treatment given to patients with recurrent rectal cancer affects their well being and quality of life.
Detailed Description
If you agree to take part in this study, you will complete 4 questionnaires at each of your regularly scheduled doctor's visits (about every 6 months). Someone will help you to go through the question...
Eligibility Criteria
Inclusion
- All patients who have had previous surgical treatment of rectal adenocarcinoma, regardless of age, with locally recurrent (pelvic) rectal adenocarcinoma are eligible, if a period of at least 3 months exists between initial treatment and disease recurrence.
- Patients may have local recurrence alone, or concurrent distant metastatic disease. Patients must have recurrent rectal cancer present in the bony pelvis.
- Patients must be conversant in English in order to complete appropriate questions.
- Patients must understand the test and questionnaire parameters, including the need for PET testing to assess the correlation between perceived symptoms and PET or other diagnostic results. Patients must be able and willing to complete all scheduled appointments and complete and return all study questionnaires.
Exclusion
- Patients must not have non-adenocarcinoma pathology, i.e., squamous cell carcinoma of the anus, cloacogenic tumors, etc.
- Patients must not have any concurrent pelvic malignancy in addition to rectal carcinoma.
- Patients must not have ONLY distant metastases. Recurrence must be present within the bony pelvis.
- Patients must not have a history of either a documented pelvic pain syndrome or a preoperative documented diagnosis of chronic constipation (defined as \< 1 BM per 48 hours, unrelated to rectal cancer or mechanical obstruction) preceding the cancer diagnosis.
- Patient must not have had solely non-operative therapies in treatment of their primary rectal carcinoma.
Key Trial Info
Start Date :
March 12 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2027
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00648635
Start Date
March 12 2008
End Date
September 30 2027
Last Update
August 27 2025
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030