MDACC Study Summary 2007-0822

Study Summary
No. 2007-0822:.......Cancer Prevention......Karen Basen-Engquist......Behavioral Science

Study Summary Title



Study Summary Number:	2007-0822

Study Title:	Take Heart: Exercise Intervention for Heart Failure in Cancer Survivors

Physician

New Patient Referral



Name:	Karen Basen-Engquist	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Behavioral Science	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-0919 Contact us about clinical trials

General Information



Disease Group:	Cancer Prevention	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Participants in the intervention group will come to M.D. Anderson Cancer Center three times a week for sixteen weeks. Participants will also be seen every 4 weeks. Participants will come to the BRTC for their follow-up 17-18 weeks after baseline.

Treatment Agents:	None	Home Care:	Participants will be given an accelerometer to wear for one week. Participants in the intervention group may be asked to exercise at home.

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	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.

Study Objectives / Outcomes

1. To pretest the intervention and assessment procedures with five participants before starting the randomized pilot test.

2. 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.

3. 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.

4. To explore Social Cognitive Theory predictors of adherence to exercise recommendations. We will test psychometric characteristics of the measures of these variables, and explore associations consistent with the conceptual model (Figures 1 and 2).

5. To evaluate the feasibility and safety of a home-based exercise intervention for cancer survivors with chemotherapy-related heart failure who are unable to participate in the randomized trial of the supervised intervention.

Study Status Information



Study Activation / Registration Date:	02/11/2008

IRB Review and Approval Date:	02/11/2008

Study Type:	Behavioral

Recruitment Status:	Open

Projected Accrual:	85

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) 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;

2) 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);

3) oriented to person, place, and time;

4) 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.

5) 18 years of age or older.

6) diagnosis of cancer

7) have completed treatment, or are on long-term adjuvant or maintenance chemotherapy only

Exclusion Criteria:

1) remain in NYHA class IV heart failure despite therapy;

2) have health problems or current treatments that would make exercise unsafe, as determined by the cardiologist;

3) cannot provide informed consent;

Links

Registration Number: NCT00633633
Study Information on Clinical Trials Registry (clinicaltrials.gov)