View Clinical Trial (Medical Research Study)
Chemoradiation-Induced Nausea and Emesis: A Prospective Study to Assess Patient Preferences and Quality of Life
| City: |
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Houston |
| State: |
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Texas |
| Zip Code: |
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77030 |
| Conditions: |
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Gastric Cancer - Pancreatic Cancer - Cervical Cancer - Vulvar Cancer - Endometrial Cancer - Anal Cancer |
| Purpose: |
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The primary objectives of this study are:
1. To assess the preferences of cancer patients scheduled to receive chemoradiation and
caregiver controls for side-effects of chemoradiation.
1. To compare preferences of cancer patients to those of healthy individuals.
2. To compare how patients' preferences for side-effects of chemoradiation change
over time.
2. To longitudinally assess the quality of life of cancer patients scheduled to receive
chemoradiation.
3. To determine the impact of nausea and vomiting associated with chemoradiation on
patients' quality of life and evaluate potential change throughout the duration of
chemoradiation treatment.
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| Study Summary: |
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You will be interviewed about your perceptions of side effects that are related to your
chemoradiation treatment. The interview will take about 20 minutes. You will be
interviewed at the beginning of your chemoradiation treatment, 3 weeks after treatment
starts, and at the first follow-up appointment after chemoradiation treatment ends.
Chemoradiation is a type of cancer treatment that involves both chemotherapy and radiation
therapy.
You will also receive a packet of 3 questionnaires to complete at different times during and
after treatment. The questionnaires include a quality of life survey that asks about
physical, social, and emotional well-being, a self-report symptom evaluation that will ask
whether you are experiencing any particular side effects and if so how much it bothers you,
and a brief survey to asks questions about anxiety and distress.
The questionnaires should take about 20 minutes each to complete. The questionnaire packet
will be given to patients at the beginning of chemoradiation treatment, 3 weeks after
treatment starts, the last day of treatment, and at the first follow-up appointment after
chemoradiation treatment ends. If the you do not have time to complete the questionnaires,
a stamped, addressed envelop will be given so that you can mail the completed packet back to
the research team.
Your participation in this research study will be over about 4-6 weeks after chemoradiation
treatment ends.
This is an investigational study. Up to 208 individuals (104 patients and 104 caregivers)
will take part in this study. All will be enrolled at M. D. Anderson.
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| Criteria: |
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Inclusion Criteria:
1. Patients receiving 5 to 6-week course of chemoradiation for abdominal-pelvic tumors
(gastric cancers, gastro-esophageal (GE) junction, pancreatic, cervix, vulvar,
endometrial, or anal) using conventional fractionation [(180cGy-200cGy per day)]
2. Patients receiving concurrent abdominal-pelvic radiation and single agent or
combination of cisplatin, paclitaxel, CPT-11, oxaliplatin or 5-FU, capecitabine,
gemcitabine, or bevacizumab (Avastin).
3. Patients must be least 18 years of age
4. Controls must be individuals with no prior cancer diagnosis
5. Controls must be at least 18 years of age
6. Controls must be the caregivers of patients on this study
Exclusion Criteria:
1. Patients who do not have a diagnosis of cervix, endometrial, vulvar or anal cancer
2. Patients who are not scheduled to receive chemoradiation treatment
3. Patients who are not at least 18 years of age
4. Controls - individuals who have a prior diagnosis of cancer (with the exception of
non-melanoma skin cancer)
5. Controls - individuals who are not at least 18 years of age
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| NCT ID: |
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NCT00394602 |
| Primary Contact: |
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Principal Investigator
Charlotte C. Sun, MD
M.D. Anderson Cancer Center
Charlotte C. Sun, MD
Phone: 713-745-4380
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| Backup Contact: |
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N/A |
| Location Contact: |
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Houston, Texas 77030
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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