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Chemoradiation-Induced Nausea and Emesis: A Prospective Study to Assess Patient Preferences and Quality of Life


N/A
18 Years
N/A
Open (Enrolling)
Both
Gastric Cancer, Pancreatic Cancer, Cervical Cancer, Vulvar Cancer, Endometrial Cancer, Anal Cancer

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Trial Information

Chemoradiation-Induced Nausea and Emesis: A Prospective Study to Assess Patient Preferences and Quality of Life


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Longitudinal Quality of Life + Symptom Assessment Data

Outcome Description:

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.

Outcome 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.

Safety Issue:

No

Principal Investigator

Charlotte C. Sun, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2003-0529

NCT ID:

NCT00394602

Start Date:

April 2004

Completion Date:

Related Keywords:

  • Gastric Cancer
  • Pancreatic Cancer
  • Cervical Cancer
  • Vulvar Cancer
  • Endometrial Cancer
  • Anal Cancer
  • Gastric Cancer
  • Pancreatic Cancer
  • Cervical Cancer
  • Vulvar Cancer
  • Endometrial Cancer
  • Anal Cancer
  • Quality of Life
  • Questionnaire
  • Interview
  • Emesis
  • Nausea
  • Survey
  • Anus Neoplasms
  • Endometrial Neoplasms
  • Uterine Cervical Neoplasms
  • Stomach Neoplasms
  • Nausea
  • Pancreatic Neoplasms
  • Vulvar Neoplasms
  • Adenoma

Name

Location
UT MD Anderson Cancer Center Houston, Texas  77030