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Evaluation of Cardiovascular Health Outcomes Among Survivors (ECHOS)

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ClinicalTrials.gov Identifier: NCT01003574
Recruitment Status : Completed
First Posted : October 29, 2009
Last Update Posted : November 26, 2013
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Risk Cancer Behavioral: lifestyle modification and telephone counseling Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 509 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Evaluation of Cardiovascular Health Outcomes Among Survivors
Study Start Date : March 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Arm Intervention/treatment
Control Arm
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.
Behavioral: lifestyle modification and telephone counseling
A mailed individualized cancer treatment summary with recommendations for CV follow-up and lifestyle modification (standard care).
Other Name: Cardiovascular Health Outcomes

Test Arm
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.
Behavioral: lifestyle modification and telephone counseling
Standard care plus motivational, autonomy-supportive APN counseling (2 phone sessions) that targets two categories of behavioral constructs likely to influence screening.
Other Name: Cardiovascular Health Outcomes




Primary Outcome Measures :
  1. 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 [ Time Frame: 2.5 years ]

Secondary Outcome Measures :
  1. Change in knowledge [ Time Frame: Baseline and 2.5 years post intervention ]
  2. Change in motivation [ Time Frame: Baseline and 2.5 years post intervention ]
  3. Change in fear [ Time Frame: Baseline and 2.5 years post intervention ]
  4. Change in beliefs [ Time Frame: Baseline and 2.5 years post intervention ]
  5. Change in affect [ Time Frame: Baseline and 2.5 years post intervention ]
  6. Change in readiness for medical follow-up [ Time Frame: Baseline and 2.5 years post intervention ]
  7. Change in self-efficacy [ Time Frame: Baseline and 2.5 years post intervention ]
  8. Estimated average cost of intervention per participant [ Time Frame: 2.5 years ]
  9. Estimated average cost of standard care per participant in the Control Arm [ Time Frame: 2.5 years ]
  10. Estimated average cost of cardiovascular screening per participant in the Test Arm [ Time Frame: 2.5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01003574


Locations
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United States, Tennessee
St . Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Melissa Hudson, MD St. Jude Children's Research Hospital

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01003574     History of Changes
Other Study ID Numbers: ECHOS
R01NR011322 ( U.S. NIH Grant/Contract )
First Posted: October 29, 2009    Key Record Dates
Last Update Posted: November 26, 2013
Last Verified: November 2013
Keywords provided by St. Jude Children's Research Hospital:
cardiovascular health outcomes in cancer survivors