NCT00827801

Brief Summary

Primary Objective: To determine if there is a reduction in the mean symptom severity scores for the heart failure specific symptom items between baseline and at the end of three months between patients whose symptoms are managed using the MDASI-HF symptom assessment scores (treatment group) as a decision making guide, as compared to patients managed without using the MDASI-HF symptom assessment scores (control group). Secondary Objectives:

  1. 1.Examine the correlation between mean symptom severity scores and the secondary endpoints of: a) exercise tolerance ( 6-minute walk), b) NYHA (New York Heart Association) functional classification, c) B-type natriuretic peptide (a biomarker for heart failure), and d) dose titration of HF (heart failure) medications.
  2. 2.Define symptom severity critical values in cancer patients with concurrent heart failure that trigger clinical intervention
  3. 3.Identify symptom clusters which may occur in cancer patients with concurrent heart failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2009

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

January 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 23, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

July 23, 2012

Status Verified

July 1, 2012

Enrollment Period

2.6 years

First QC Date

January 22, 2009

Last Update Submit

July 19, 2012

Conditions

Heart FailureCancer

Keywords

CancerHeart FailureHFCancer and Concurrent Heart FailureMDASI-HF Symptom Management ProgramMDASI-HFMDASI-HF questionnaireM. D. Anderson Symptom Inventory - Heart FailureQuestionnaireSymptom Management Gap

Outcome Measures

Primary Outcomes (1)

  • Mean Symptom Severity Scores (MDASI-HF Symptom Assessment Scores)

    Baseline and at end of 3 Months

Study Arms (2)

Group 1

MDASI-HF questionnaire provided to Doctor for symptom management.

Behavioral: MDASI-HF Questionnaire

Group 2

MDASI-HF questionnaire collected not provided to Doctor.

Behavioral: MDASI-HF Questionnaire

Interventions

MDASI-HF QuestionnaireBEHAVIORAL

M. D. Anderson Symptom Inventory - Heart Failure (MDASI-HF) questionnaire rating symptoms given in clinic Day 1, Weeks 4 \& 8.

Also known as: survey
Group 1Group 2

Eligibility Criteria

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

All cancer patients, 18 years of age or older, with a concurrent diagnosis of heart failure, newly diagnosed or diagnosed within past 1 year.

You may qualify if:

  • All cancer patients with a concurrent diagnosis of heart failure. Heart failure can be systolic (\<40% ejection fraction) or diastolic (\>40% ejection fraction). Functioning at New York Heart Association class II, III, or IV.
  • Age 18 years and older
  • Able to give informed consent to participate
  • Working phone number to contact patient
  • Live within the 100 mile radius of the Houston area while enrolled in the study for the three month duration

You may not qualify if:

  • Younger than 18 years old
  • With a known diagnosis of dementia or Alzheimer's disease
  • Not familiar with the English language. The MDASI-HF is currently available in the English language only.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Heart FailureNeoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Anecita Fadol, PhD, MS

    UT MD 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

January 22, 2009

First Posted

January 23, 2009

Study Start

January 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

July 23, 2012

Record last verified: 2012-07

Locations

US(1)