Evaluation of Cardiovascular Health Outcomes Among Survivors (ECHOS)

St. Jude Children's Research Hospital

Status: Completed

Conditions: Cancer; Cardiovascular Risk

Treatments: Behavioral: lifestyle modification and telephone counseling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01003574

R01NR011322 (U.S. NIH Grant/Contract)

ECHOS

Details and patient eligibility

About

This study will test a 2-tiered tailored intervention and evaluation of cardiovascular health outcomes among survivors designed to inform childhood cancer survivors about their individual cardiac risk and follow-up recommendations and to provide motivational support for cardiovascular (CV) screening. This study will test if the addition of telephone motivational interviewing, tailored to behavioral constructs, is superior to the current standard of care in increasing survivors' CV screening.

Full description

• This study will test the hypothesis that at 1 year post-intervention, a significantly greater proportion of the advanced-practice nurse (APN) phone counseling group will have undergone cardiovascular screening, as compared to the standard care group. Cardiovascular (CV) screening will be defined, based on established CV screening recommendations, as completion of an imaging evaluation of left ventricular systolic function (i.e., echocardiogram, multiple uptake gated acquisition scan, or cardiac magnetic resonance imaging).

• This study will measure changes induced by the intervention in survivors' knowledge, motivation, fear, beliefs, affect, readiness for medical follow-up, and self-efficacy and these changes' potential mediating effects on CV screening.

  • This study will provide a cost analysis of the ECHOS intervention in terms of the cost of left ventricular systolic function imaging per additional survivor screened, an estimate of the cost of standard care per survivor screened, and the cost of screening and follow-up per survivor screened.

Enrollment: 509 patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Childhood Cancer Survivor Study (CCSS) cohort participants
2. Age 25 years or older
3. No CV screening in previous 5 years
4. Received anthracycline chemotherapy and/or irradiation of the chest
5. Previous history of successful independent (non-surrogate) response to CCSS surveys (reading level for non-medical items is 4th-6th grade Flesch-Kincaid level).

Exclusion criteria

1. Being followed at an institution actively recruiting adults to a long-term follow-up program (ascertained in CCSS follow-up database)
2. Inability or unwillingness of research participant to give written informed consent.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

509 participants in 2 patient groups

Control Arm

Other group

Description:

Control arm will receive standard care for risk of cardiac sequelae - a mailed, tailored (neither generic nor targeted) print summary of individualized information about the survivor's treatment, late effects risks, and recommended follow-up and lifestyle modifications.

Treatment:

Behavioral: lifestyle modification and telephone counseling

Behavioral: lifestyle modification and telephone counseling

Test Arm

Other group

Description:

Test arm will receive standard care plus motivational, autonomy-supportive APN counseling (2 phone sessions) that targets two categories of behavioral constructs likely to influence screening.

Treatment:

Behavioral: lifestyle modification and telephone counseling

Behavioral: lifestyle modification and telephone counseling