Fatigue Experience in Cancer Patients

This study has been completed.
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00450541
First received: March 20, 2007
Last updated: July 26, 2012
Last verified: July 2012
  Purpose

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 Intervention
Advanced Cancer
Behavioral: Questionnaire
Behavioral: Interview

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Description of Cancer Patient Fatigue Experiences (Questionnaire + Interview Responses) [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Enrollment: 73
Study Start Date: March 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Fatigue Questionnaire + Interview Behavioral: Questionnaire
Four questionnaires taking 15-20 minutes total to complete.
Other Name: Survey
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:

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

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

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00450541     History of Changes
Other Study ID Numbers: 2007-0004
Study First Received: March 20, 2007
Last Updated: July 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancer
Fatigue
Interview
Questionnaire
Survey

Additional relevant MeSH terms:
Fatigue
Neoplasms
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014