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Chemoradiation-Induced Nausea and Emesis: Quality of Life

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ClinicalTrials.gov Identifier: NCT00394602
Recruitment Status : Active, not recruiting
First Posted : November 1, 2006
Last Update Posted : May 11, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

October 30, 2006
November 1, 2006
May 11, 2018
April 7, 2004
April 2019   (Final data collection date for primary outcome measure)
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.
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Complete list of historical versions of study NCT00394602 on ClinicalTrials.gov Archive Site
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Chemoradiation-Induced Nausea and Emesis: Quality of Life
Chemoradiation-Induced Nausea and Emesis: A Prospective Study to Assess Patient Preferences and Quality of Life

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.

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.

Observational
Observational Model: Case-Control
Time Perspective: Prospective
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Non-Probability Sample
Patients receiving chemoradiation for abdominal-pelvic tumors and healthy controls.
  • Gastric Cancer
  • Pancreatic Cancer
  • Cervical Cancer
  • Vulvar Cancer
  • Endometrial Cancer
  • Anal Cancer
  • 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
  • Patients
    Patients receiving chemoradiation for abdominal-pelvic tumors.
    Interventions:
    • Behavioral: Interview
    • Other: Questionnaire
  • Caregiver Controls
    Healthy controls with no prior cancer diagnosis.
    Intervention: Behavioral: Interview
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
207
200
April 2019
April 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00394602
2003-0529
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Merck Sharp & Dohme Corp.
Principal Investigator: Charlotte C. Sun, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
May 2018