A Pilot Study for Prospective Discovery of Possible Relationship Between Quality of Life, Treatment Modalities, and Patient Treatment/Outcome Expectations in Patients Undergoing Treatment for Locally Recurrent Rectal Adenocarcinoma
N/A
N/A
Both
Rectal Cancer
Trial Information
A Pilot Study for Prospective Discovery of Possible Relationship Between Quality of Life, Treatment Modalities, and Patient Treatment/Outcome Expectations in Patients Undergoing Treatment for Locally Recurrent Rectal Adenocarcinoma
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). If at any time during the study
you must stay in the hospital, you will complete the questionnaires during the hospital
stay. 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 return them in a self-addressed stamped envelope that you will be given. 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 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 and during any hospital stay (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 that
you take as part of your standard of care. By viewing PET scan images, researchers hope to
be able to discover whether there is any connection between the images on the PET scan and
the symptoms that you are having. The PET scan is 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 100 patients will take part in this study. All will
be enrolled at M. D. 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.
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Quality of Life (QOL) Survey Responses
Outcome Time Frame:
Baseline and QOL at 6-month intervals for 5 years
Safety Issue:
No
Principal Investigator
John Skibber, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2007-0322
NCT ID:
NCT00648635
Start Date:
March 2008
Completion Date:
Related Keywords:
- Rectal Cancer
- Rectal Cancer
- Recurrent Rectal Adenocarcinoma
- Quality of Life
- QOL
- Questionnaire
- Survey
- Adenocarcinoma
- Rectal Neoplasms
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
