Relationship Between Quality of Life, Treatment Modalities, and Patient Treatment/Outcome Expectations
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.
- (A) Assess and estimate any potential association between the change of Quality of Life (QOL), patient expectations during treatment, effectiveness of treatment and pain management in patients with recurrent rectal carcinoma. (B) Estimate the association between baseline and long-term patient-reported pain responses, patient-reported symptoms and information obtained through review of patient (positron emission tomography) PET scans
- Develop and maintain a prospective database of patients with recurrent rectal carcinoma
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||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|
- Quality of Life (QOL) Survey Responses [ Time Frame: Baseline and QOL at 6-month intervals for 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2008|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
PET + QOL
Survey of how recurrent rectal cancer treatment affects well being + QOL
Questionnaires taking 30-60 minutes to complete every 3 months.
Other Name: Survey
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.
|Contact: John Skibber, MD||713-792-6940|
|United States, Texas|
|UT MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: John Skibber, MD|
|Principal Investigator:||John Skibber, MD||M.D. Anderson Cancer Center|