Lifestyle Intervention for Heart Failure - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00633633

Purpose

The goal of this behavioral research study is to learn if education and training about exercise can help to change the lifestyle of cancer survivors with symptoms of heart failure.

Objectives:

To pretest the intervention and assessment procedures with five participants before starting the randomized pilot test.
To evaluate the feasibility of a randomized controlled trial of a lifestyle intervention for chemotherapy-related heart failure in cancer survivors. The intervention will involve supervised cardiovascular exercise. Feasibility will be assessed by monitoring recruitment and retention rates, participant safety, intervention session attendance, contamination between study arms, and participant satisfaction.
To investigate the effect of the lifestyle intervention on primary outcomes (cardiorespiratory fitness, heart failure symptoms, heart failure disease progression), secondary outcomes (physical functioning, role functioning, health care utilization), adherence to behaviors (exercise), and behavioral mediators (exercise self-efficacy, and psychological distress). Because this is a pilot study, data will be used to develop effect size and variance estimates to be used in planning a larger randomized trial.
To explore Social Cognitive Theory predictors of adherence to exercise recommendations. Researchers will test psychometric characteristics of the measures of these variables, and explore associations consistent with the conceptual model.

Condition	Intervention
Heart Failure	Other: Usual Care Behavioral: Exercise Training Behavioral: Dietary Counseling

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Take Heart: Exercise & Diet Intervention for Heart Failure in Cancer Survivors

Resource links provided by NLM:

MedlinePlus related topics: Cancer Diets Exercise and Physical Fitness Heart Failure

U.S. FDA Resources

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

Primary Outcome Measures:

To learn if education and training about exercise and diet can help to change the lifestyle of cancer survivors with symptoms of heart failure. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Estimated Enrollment:	85
Study Start Date:	February 2008
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1 Usual Care	Other: Usual Care Monthly visits with the cardiology team and a booklet about coping with heart failure.
Group 2: Experimental Exercise Training + Dietary Counseling	Other: Usual Care Monthly visits with the cardiology team and a booklet about coping with heart failure. Behavioral: Exercise Training Exercise training 3 times a week. Behavioral: Dietary Counseling Food log, booklet, and a cookbook to help decrease the salt content in your diet.

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

diagnosis of NYHA II or III heart failure within the past 6 months (as identified by any of the following physical findings of heart failure (jugular venous distension, crackles, edema, S3); pulmonary edema on chest x-ray; BNP > 100 pg/ml; or at least two of the following symptoms: paroxysmal nocturnal dyspnea, shortness of breath, swelling, fatigue;
previous chemotherapy that contributed to the development of heart failure (i.e., heart failure develops or worsens after receiving chemotherapy, with no other obvious explanation);
oriented to person, place, and time;
living in the Houston area (Harris county or a contiguous county);
18 years of age or older.
diagnosis of cancer

Exclusion Criteria:

remain in NYHA class IV heart failure despite therapy;
have health problems or current treatments that would make exercise unsafe, as determined by the cardiologist;
cannot provide informed consent;
life expectancy is less than 6 months.
currently receiving chemotherapy treatment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00633633

Contacts

Contact: Karen Basen-Engquist, PhD

713-792-0919

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Karen Basen-Engquist, PhD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Karen Basen-Engquist, PhD

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

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

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Karen Basen-Engquist, PhD/Professor )
Study ID Numbers:	2007-0822
Study First Received:	March 5, 2008
Last Updated:	July 31, 2009
ClinicalTrials.gov Identifier:	NCT00633633 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Heart Failure
Lifestyle Intervention
Exercise
Diet

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 10, 2009