Relationship Between Quality of Life, Treatment Modalities, and Patient Treatment/Outcome Expectations

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 questionnaires when you are given your first packet. If you are unable to
complete the questionnaires while at your study visit, you may choose to take some or all of
the questionnaires home. If you take the questionnaires home, you will be given a
self-addressed stamped envelope so that you can return them to the study coordinator. If you
choose, you may also complete the questionnaires over the phone.

The questionnaires will ask you about how you feel about the cancer treatment, how treatment
for rectal cancer has affected your health and lifestyle, what you expect during and after
your treatment, and about any pain you are experiencing and if the pain management is working
for you. It should take about 30-60 minutes to complete the questionnaires each time.

If you will not be in the clinic for more than 6 months, the questionnaires will be mailed to
you. You will return them in a self-addressed stamped envelope. If you have not completed the
questionnaires within 2 weeks of receiving them, a research staff member will call you to
remind you to complete the questionnaires, and to assist you with completing them (if
necessary). If you have not completed the questionnaires by the time you come for your next
follow-up visit, a research staff member will assist you with completing them at your visit
(if necessary).

If your questionnaire responses show that you may be having emotional difficulties or
depression, you will be provided with names of mental health providers in case you would like
to receive mental health screening.

At each of your appointments or between your appointments (if needed) researchers will
collect study related information for your medical record.

Researchers will also review the images of the positron emission tomography (PET) scans or
other diagnostic tests that you take as part of your standard of care. By viewing PET scan
images or diagnostic tests, researchers hope to be able to discover whether there is any
connection between the images on the PET scan or diagnostic tests and the symptoms that you
are having. The PET scan or other diagnostic tests is are part of your standard treatment for
your recurrent rectal cancer, and you will not have to have any special tests or scans just
to participate in this study.

The data researchers collect will also be used to form a database of patients with recurrent
rectal cancer. The database will be located on a password protected Surgical Oncology
computer and it will be available only to the study doctor and the research staff that need
to complete the study. The database will include information about each participant on the
study. It will include information about the participant's name, medical record number, age,
gender, diagnosis, the study questionnaires, and information about the disease.

Length of Study:

You will remain on study for up to 5 years.

This is an investigational study.

Up to 164 patients will take part in this study. All will be enrolled at MD Anderson.

Inclusion Criteria:

1. 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.

2. Patients may have local recurrence alone, or concurrent distant metastatic disease.
Patients must have recurrent rectal cancer present in the bony pelvis.

3. Patients must be conversant in English in order to complete appropriate questions.

4. 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 Criteria:

1. Patients must not have non-adenocarcinoma pathology, i.e., squamous cell carcinoma of
the anus, cloacogenic tumors, etc.

2. Patients must not have any concurrent pelvic malignancy in addition to rectal
carcinoma.

3. Patients must not have ONLY distant metastases. Recurrence must be present within the
bony pelvis.

4. 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.

5. Patient must not have had solely non-operative therapies in treatment of their primary
rectal carcinoma.