NCT00633633

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
85

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Feb 2008

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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

February 11, 2008

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2008

Completed
18.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Completed
Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

18.3 years

First QC Date

March 5, 2008

Last Update Submit

January 13, 2026

Conditions

Keywords

Heart FailureLifestyle InterventionExerciseDiet

Outcome Measures

Primary Outcomes (1)

  • Recruitment/Attendance/Drop-Out Rates

    1 Year

Study Arms (2)

Group 1

OTHER

Usual Care

Other: Usual Care

Group 2

EXPERIMENTAL

Exercise Training + Dietary Counseling

Other: Usual CareBehavioral: Exercise TrainingBehavioral: Dietary Counseling

Interventions

Monthly visits with the cardiology team and a booklet about coping with heart failure.

Group 1Group 2

Exercise training 3 times a week.

Group 2

Food log, booklet, and a cookbook to help decrease the salt content in your diet.

Group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of NYHA I, II or III heart failure (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), or planning to stay in the area for at least the next 16 weeks.
  • years of age or older.
  • diagnosis of cancer
  • have completed treatment, or are on long-term adjuvant or maintenance chemotherapy only

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78249, United States

Location

Related Publications (1)

  • Tsai E, Mouhayar E, Lenihan D, Song J, Durand JB, Fadol A, Massey M, Harrison C, Basen-Engquist K. Feasibility and Outcomes of an Exercise Intervention for Chemotherapy-Induced Heart Failure. J Cardiopulm Rehabil Prev. 2019 May;39(3):199-203. doi: 10.1097/HCR.0000000000000388.

Related Links

MeSH Terms

Conditions

Heart FailureMotor Activity

Interventions

ExerciseNutrition Assessment

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Karen Basen-Engquist, PhD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2008

First Posted

March 12, 2008

Study Start

February 11, 2008

Primary Completion

May 31, 2026

Study Completion

May 31, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Locations