Fatigue Experience in Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00450541
Recruitment Status : Completed
First Posted : March 22, 2007
Last Update Posted : July 30, 2012
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this research study is to learn what it is like when a patient with cancer has fatigue, as well as how these patients define fatigue. Researchers want to use this information to create questionnaires that may more accurately measure fatigue and its effects in patients with cancer.

Condition or disease Intervention/treatment
Advanced Cancer Behavioral: Questionnaire Behavioral: Interview

Detailed Description:


If you agree to take part in this study, you will be interviewed by a member of the study staff and then asked to complete a series of questionnaires and verbal (spoken) questions.

During the interview, you will be asked to describe what fatigue means to you and what it is like for you to have fatigue. The interview will take place while you are at M. D. Anderson receiving your routine care. You will be interviewed alone, and the information gathered during the interview will be kept strictly confidential. The interview will take about 30 minutes to complete. It will be audiotaped so that participants' responses can be fully analyzed.

You will then be asked to complete 4 questionnaires and answer 2 separate questions.

The first questionnaire will include questions about your personal identifying information (such as your age and marital status).

You will then be asked 1 question about your quality of life and another question about how well you are performing day-to-day activities.

You will then be asked to complete a second questionnaire in which you will rate your fatigue level and how fatigue interferes with your daily activities.

You will be asked to complete a third questionnaire about your opinion of the fatigue questionnaire (the second questionnaire). For example, you will be asked if the fatigue questionnaire was easy to understand and to complete. Learning your opinion about this questionnaire will help researchers learn what important questions may be missing from the questionnaire.

Finally, you will then be asked to complete a questionnaire that asks you to rate the severity of a list of 13 symptoms and how much these symptoms interfere with some of your daily activities.

The questionnaires and additional questions should take a total of 15-20 minutes to complete.

After you have completed the interview and questionnaires, a research assistant will review your electronic medical record to collect information about your disease and treatments.


Your participation in this study will be over after you complete the interview, the questionnaires, and the additional questions.

This is an investigational study. Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Type : Observational
Actual Enrollment : 73 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Experience of Fatigue for Patients With Cancer
Study Start Date : March 2007
Primary Completion Date : April 2010
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue
U.S. FDA Resources

Group/Cohort Intervention/treatment
Fatigue Questionnaire + Interview Behavioral: Questionnaire
Four questionnaires taking 15-20 minutes total to complete.
Other Name: Survey
Behavioral: Interview
Interview lasting about 30 minutes.

Primary Outcome Measures :
  1. Description of Cancer Patient Fatigue Experiences (Questionnaire + Interview Responses) [ Time Frame: 2 Years ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with cancer that may be experiencing fatigue.

Inclusion Criteria:

  1. 18 years of age or older
  2. Ability to speak and read English
  3. Diagnosis of cancer, currently receiving treatment, receiving supportive care, or surviving after treatment
  4. Self report of current experience of fatigue
  5. Consent to participate
  6. Patient from M. D. Anderson Cancer Center inpatient unit or outpatient clinic

Exclusion Criteria:

  1. Inability to understand the intent of the study
  2. Medical condition that would preclude participation in an interview session lasting 40 minutes
  3. Diagnosis of active psychosis or severe cognitive impairment confirmed by the patient's attending physician.

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 identifier (NCT number): NCT00450541

United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Loretta A. Williams, DSN M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00450541     History of Changes
Other Study ID Numbers: 2007-0004
First Posted: March 22, 2007    Key Record Dates
Last Update Posted: July 30, 2012
Last Verified: July 2012

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancer

Additional relevant MeSH terms:
Signs and Symptoms