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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00827801
First received: January 22, 2009
Last updated: July 19, 2012
Last verified: July 2012
  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:

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

Condition Intervention
Heart Failure
Cancer
Behavioral: MDASI-HF Questionnaire

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Mean Symptom Severity Scores (MDASI-HF Symptom Assessment Scores) [ Time Frame: Baseline and at end of 3 Months ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: January 2009
Study Completion Date: August 2011
Primary Completion Date: August 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.
Other Name: survey
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.
Other Name: survey

  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:

  1. 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.
  2. Age 18 years and older
  3. Able to give informed consent to participate
  4. Working phone number to contact patient
  5. Live within the 100 mile radius of the Houston area while enrolled in the study for the three month duration

Exclusion Criteria:

  1. Younger than 18 years old
  2. With a known diagnosis of dementia or Alzheimer's disease
  3. Not familiar with the English language. The MDASI-HF is currently available in the English language only.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Anecita Fadol, PhD, MS UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00827801     History of Changes
Other Study ID Numbers: 2007-0722
Study First Received: January 22, 2009
Last Updated: July 19, 2012
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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 20, 2014