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OpenTrials
Completed

NCT Number: NCT00450541

Fatigue Experience in Cancer Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Questionnaire

Behavioral

Four questionnaires taking 15-20 minutes total to complete.

Other names: Survey

Interview

Behavioral

Interview lasting about 30 minutes.

Primary outcomes

  1. Description of Cancer Patient Fatigue Experiences (Questionnaire + Interview Responses)

    Time frame: 2 Years

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • Cephalon

Registry information

Official study title

The Experience of Fatigue for Patients With Cancer

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Mar 22, 2007
Registry last updated
Jul 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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