M. D. Anderson Symptom Inventory - Heart Failure (MDASI-HF) Symptom Management Program - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00827801

Purpose

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:

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.
Define symptom severity critical values in cancer patients with concurrent heart failure that trigger clinical intervention
Identify symptom clusters which may occur in cancer patients with concurrent heart failure.

Condition	Intervention
Heart Failure Cancer	Behavioral: MDASI-HF Questionnaire

MedlinePlus related topics: Cancer Heart Failure Palliative Care

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	MDASI-HF: Bridging the Symptom Management Gap in Patients With Cancer and Concurrent Heart Failure to Improve Outcomes

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

Primary Outcome Measures:

To compare a newly-designed symptom management program [M. D. Anderson Symptom Inventory - Heart Failure (MDASI-HF)] with the standard of care for symptom management, in patients with cancer and heart failure. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To learn if the MDASI-HF tool can help doctors in their decision-making when it comes to managing heart failure in cancer patients. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	144
Study Start Date:	January 2009
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Group 1 MDASI-HF questionnaire provided to Doctor for symptom management.	Behavioral: MDASI-HF Questionnaire M. D. Anderson Symptom Inventory - Heart Failure (MDASI-HF) questionnaire rating symptoms given in clinic Day 1, Weeks 4 & 8.
Group 2 MDASI-HF questionnaire collected not provided to Doctor.	Behavioral: MDASI-HF Questionnaire M. D. Anderson Symptom Inventory - Heart Failure (MDASI-HF) questionnaire rating symptoms given in clinic Day 1, Weeks 4 & 8.

Show Detailed Description

Eligibility

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827801

Contacts

Contact: Anecita Fadol, PhD, MS

713-792-8397

Locations

United States, Texas
UT MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Anecita Fadol, PhD, MS

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Anecita Fadol, PhD, MS

UT MD Anderson Cancer Center

More Information

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

Responsible Party:	UT MD Anderson Cancer Center ( Anecita Fadol, PhD, MS/Advanced Practice Nurse )
Study ID Numbers:	2007-0722
Study First Received:	January 22, 2009
Last Updated:	January 22, 2009
ClinicalTrials.gov Identifier:	NCT00827801
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Cancer
Heart Failure
HF
Cancer and Concurrent Heart Failure
MDASI-HF Symptom Management Program

MDASI-HF
MDASI-HF questionnaire
M. D. Anderson Symptom Inventory - Heart Failure
Questionnaire
Symptom Management Gap

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 30, 2009