Chemoradiation-Induced Nausea and Emesis: Quality of Life
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Purpose
The primary objectives of this study are:
To assess the preferences of cancer patients scheduled to receive chemoradiation and caregiver controls for side-effects of chemoradiation.
- To compare preferences of cancer patients to those of healthy individuals.
- To compare how patients' preferences for side-effects of chemoradiation change over time.
- To longitudinally assess the quality of life of cancer patients scheduled to receive chemoradiation.
- 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.
| Condition | Intervention |
|---|---|
|
Gastric Cancer Pancreatic Cancer Cervical Cancer Vulvar Cancer Endometrial Cancer Anal Cancer |
Behavioral: Interview Other: Questionnaire |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Chemoradiation-Induced Nausea and Emesis: A Prospective Study to Assess Patient Preferences and Quality of Life |
- Longitudinal Quality of Life + Symptom Assessment Data [ Time Frame: Survey(s) & Interveiw(s) at baseline (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. ] [ Designated as safety issue: No ]Quality of life survey instruments scored according to EORTC QLQ-C30 scoring manual. Patients and controls compared with respect to preference data. The control group preference data collected at only 1 time point, but patient preference data from each time point will be compared to these control group preference data.
| Estimated Enrollment: | 200 |
| Study Start Date: | April 2004 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Patients
Patients receiving chemoradiation for abdominal-pelvic tumors.
|
Behavioral: Interview
Interview regarding perceptions of side effects that are related to chemoradiation treatment.
Other: Questionnaire
3 Questionnaires regarding quality of life given during and after treatment, each taking about 20 minutes to complete.
Other Name: Survey
|
|
Caregiver Controls
Healthy controls with no prior cancer diagnosis.
|
Behavioral: Interview
Interview regarding perceptions of side effects that are related to chemoradiation treatment.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Patients receiving chemoradiation for abdominal-pelvic tumors and healthy controls.
Inclusion Criteria:
- 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)]
- 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).
- Patients must be least 18 years of age
- Controls must be individuals with no prior cancer diagnosis
- Controls must be at least 18 years of age
- Controls must be the caregivers of patients on this study
Exclusion Criteria:
- Patients who do not have a diagnosis of cervix, endometrial, vulvar or anal cancer
- Patients who are not scheduled to receive chemoradiation treatment
- Patients who are not at least 18 years of age
- Controls - individuals who have a prior diagnosis of cancer (with the exception of non-melanoma skin cancer)
- Controls - individuals who are not at least 18 years of age
Contacts and Locations| Contact: Charlotte C. Sun, MD | 713-745-4380 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Charlotte C. Sun, MD | |
| Principal Investigator: | Charlotte C. Sun, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00394602 History of Changes |
| Other Study ID Numbers: | 2003-0529 |
| Study First Received: | October 30, 2006 |
| Last Updated: | December 17, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Gastric Cancer Pancreatic Cancer Cervical Cancer Vulvar Cancer Endometrial Cancer Anal Cancer |
Quality of Life Questionnaire Interview Emesis Nausea Survey |
Additional relevant MeSH terms:
|
Uterine Diseases Anus Neoplasms Endometrial Neoplasms Uterine Cervical Neoplasms Stomach Neoplasms Nausea Pancreatic Neoplasms Vulvar Neoplasms Adenoma Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Anus Diseases Rectal Diseases Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Genital Diseases, Female Uterine Cervical Diseases Stomach Diseases Signs and Symptoms, Digestive Signs and Symptoms Endocrine Gland Neoplasms |
ClinicalTrials.gov processed this record on May 21, 2013