Clinical trial NCT01003574: Evaluation of Cardiovascular Health Outcomes Among Survivors
Official title: Evaluation of Cardiovascular Health Outcomes Among Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk
Cancer
Keywords: cardiovascular health outcomes in cancer survivors
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2009-10-29
Enrollment: 509
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: This study will test the hypothesis that at 1 year post-intervention, a significantly greater proportion of the APN phone counseling group will have undergone cardiovascular screening, as compared to the standard care group
timeFrame: 2.5 years
Secondary outcomes:
measure: Change in knowledge
timeFrame: Baseline and 2.5 years post intervention
measure: Change in motivation
timeFrame: Baseline and 2.5 years post intervention
measure: Change in fear
timeFrame: Baseline and 2.5 years post intervention
measure: Change in beliefs
timeFrame: Baseline and 2.5 years post intervention
measure: Change in affect
timeFrame: Baseline and 2.5 years post intervention
measure: Change in readiness for medical follow-up
timeFrame: Baseline and 2.5 years post intervention
measure: Change in self-efficacy
timeFrame: Baseline and 2.5 years post intervention
measure: Estimated average cost of intervention per participant
timeFrame: 2.5 years
measure: Estimated average cost of standard care per participant in the Control Arm
timeFrame: 2.5 years
measure: Estimated average cost of cardiovascular screening per participant in the Test Arm
timeFrame: 2.5 years
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St . Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Melissa Hudson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hudson MM, Leisenring W, Stratton KK, Tinner N, Steen BD, Ogg S, Barnes L, Oeffinger KC, Robison LL, Cox CL. Increasing cardiomyopathy screening in at-risk adult survivors of pediatric malignancies: a randomized controlled trial. J Clin Oncol. 2014 Dec 10;32(35):3974-81. doi: 10.1200/JCO.2014.57.3493. Epub 2014 Nov 3.