Relationship Between Quality of Life, Treatment Modalities, and Patient Treatment/Outcome Expectations
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Purpose
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.
Objectives:
- (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
| Condition | Intervention |
|---|---|
|
Rectal Cancer |
Behavioral: Questionnaire |
| Study Type: | Observational |
| 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 ]
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2008 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
PET + QOL
Survey of how recurrent rectal cancer treatment affects well being + QOL
|
Behavioral: Questionnaire
Questionnaires taking 30-60 minutes to complete every 3 months.
Other Name: Survey
|
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). 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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with recurrent rectal cancer.
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00648635 History of Changes |
| Other Study ID Numbers: | 2007-0322 |
| Study First Received: | March 27, 2008 |
| Last Updated: | May 10, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Rectal Cancer Recurrent Rectal Adenocarcinoma Quality of Life |
QOL Questionnaire Survey |
Additional relevant MeSH terms:
|
Adenocarcinoma Rectal Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Colorectal Neoplasms Intestinal Neoplasms |
Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013