Clinical trial NCT00394602: Chemoradiation-Induced Nausea and Emesis: Quality of Life
Official title: Chemoradiation-Induced Nausea and Emesis: A Prospective Study to Assess Patient Preferences and Quality of Life
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Gastric Cancer
Pancreatic Cancer
Cervical Cancer
Vulvar Cancer
Endometrial Cancer
Anal Cancer
Keywords: Gastric Cancer
Pancreatic Cancer
Cervical Cancer
Vulvar Cancer
Endometrial Cancer
Anal Cancer
Quality of Life
Questionnaire
Interview
Emesis
Nausea
Survey
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2006-11-01
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving chemoradiation for abdominal-pelvic tumors and healthy controls.

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.

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 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

Primary outcomes:
measure: Longitudinal Quality of Life + Symptom Assessment Data
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Charlotte C. Sun, MD
role: PRINCIPAL_INVESTIGATOR
References: