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Chemoradiation-Induced Nausea and Emesis: Quality of Life

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ClinicalTrials.gov Identifier: NCT00394602
Recruitment Status : Recruiting
First Posted : November 1, 2006
Last Update Posted : January 15, 2018
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.

Condition or disease Intervention/treatment
Gastric Cancer Pancreatic Cancer Cervical Cancer Vulvar Cancer Endometrial Cancer Anal Cancer Behavioral: Interview Other: Questionnaire

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.


Study Design

Study Type : Observational
Estimated Enrollment : 200 participants
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
Actual Study Start Date : April 2004
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Longitudinal Quality of Life + Symptom Assessment Data [ Time Frame: Survey(s) & Interview(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. ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving chemoradiation for abdominal-pelvic tumors and healthy controls.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00394602


Contacts
Contact: Charlotte C. Sun, MD 713-745-4380

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Charlotte C. Sun, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Charlotte C. Sun, MD M.D. Anderson Cancer Center
More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00394602     History of Changes
Other Study ID Numbers: 2003-0529
First Posted: November 1, 2006    Key Record Dates
Last Update Posted: January 15, 2018
Last Verified: January 2018

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:
Vulvar Diseases
Pancreatic Neoplasms
Stomach Neoplasms
Uterine Cervical Neoplasms
Nausea
Endometrial Neoplasms
Anus Neoplasms
Vulvar Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Stomach Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Signs and Symptoms, Digestive
Signs and Symptoms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Intestinal Diseases