Chemoradiation-Induced Nausea and Emesis: Quality of Life

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00394602
First received: October 30, 2006
Last updated: July 1, 2014
Last verified: July 2014
  Purpose

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 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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 2016 (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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394602

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

Locations
United States, Texas
UT 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:
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: July 1, 2014
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:
Stomach Diseases
Anus Neoplasms
Endometrial Neoplasms
Uterine Cervical Neoplasms
Stomach Neoplasms
Nausea
Pancreatic Neoplasms
Vulvar Neoplasms
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
Uterine Diseases
Genital Diseases, Female
Uterine Cervical Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Endocrine Gland Neoplasms
Pancreatic Diseases

ClinicalTrials.gov processed this record on July 24, 2014