Fatigue Experience in Cancer Patients - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center Cephalon
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00450541

Purpose

Primary Objective:

-To develop a detailed description of the experience of fatigue for patients with cancer.

Secondary Objective:

-To define the content domain for the assessment and measurement of fatigue in patients with cancer.

Condition	Intervention
Advanced Cancer	Behavioral: Questionnaire Behavioral: Interview

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	The Experience of Fatigue for Patients With Cancer

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

Primary Outcome Measures:

To learn what it is like when a patient with cancer has fatigue, as well as how these patients define fatigue. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To use this information to create questionnaires that may more accurately measure fatigue and its effects in patients with cancer. [ Time Frame: 2 Year ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	60
Study Start Date:	March 2007
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Patients with cancer that may be experiencing fatigue.	Behavioral: Questionnaire Four questionnaires taking 15-20 minutes total to complete. Behavioral: Interview Interview lasting about 30 minutes.

Detailed Description:

STUDY PARTICIPATION:

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.

LENGTH OF STUDY:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with cancer that may be experiencing fatigue.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00450541

Contacts

Contact: Loretta A. Williams, DSN

713-745-3470

Locations

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

Sponsors and Collaborators

M.D. Anderson Cancer Center

Cephalon

Investigators

Principal Investigator:

Loretta A. Williams, DSN

U.T.M.D. Anderson Cancer Center

More Information

MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Loretta A. Williams, DSN )
Study ID Numbers:	2007-0004
Study First Received:	March 20, 2007
Last Updated:	December 31, 2008
ClinicalTrials.gov Identifier:	NCT00450541
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Advanced Cancer
Fatigue
Interview
Questionnaire
Survey

Study placed in the following topic categories:

Fatigue

ClinicalTrials.gov processed this record on January 14, 2009