NCT00450541

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

July 30, 2012

Status Verified

July 1, 2012

Enrollment Period

3.1 years

First QC Date

March 20, 2007

Last Update Submit

July 26, 2012

Conditions

Keywords

Advanced CancerFatigueInterviewQuestionnaireSurvey

Outcome Measures

Primary Outcomes (1)

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

    2 Years

Study Arms (1)

Fatigue Questionnaire + Interview

Behavioral: QuestionnaireBehavioral: Interview

Interventions

QuestionnaireBEHAVIORAL

Four questionnaires taking 15-20 minutes total to complete.

Also known as: Survey
Fatigue Questionnaire + Interview
InterviewBEHAVIORAL

Interview lasting about 30 minutes.

Fatigue Questionnaire + Interview

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with cancer that may be experiencing fatigue.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Fatigue

Interventions

Surveys and QuestionnairesInterviews as Topic

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Loretta A. Williams, DSN

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2007

First Posted

March 22, 2007

Study Start

March 1, 2007

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

July 30, 2012

Record last verified: 2012-07

Locations