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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR011322 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | Other | 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. |
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| Test Arm | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lifestyle modification and telephone counseling | Behavioral | A mailed individualized cancer treatment summary with recommendations for CV follow-up and lifestyle modification (standard care). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in knowledge | Baseline and 2.5 years post intervention | |
| Change in motivation | Baseline and 2.5 years post intervention | |
| Change in fear |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Hudson, MD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St . Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25366684 | Derived | 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. |
| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| lifestyle modification and telephone counseling | Behavioral | Standard care plus motivational, autonomy-supportive APN counseling (2 phone sessions) that targets two categories of behavioral constructs likely to influence screening. |
|
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| Baseline and 2.5 years post intervention |
| Change in beliefs | Baseline and 2.5 years post intervention |
| Change in affect | Baseline and 2.5 years post intervention |
| Change in readiness for medical follow-up | Baseline and 2.5 years post intervention |
| Change in self-efficacy | Baseline and 2.5 years post intervention |
| Estimated average cost of intervention per participant | 2.5 years |
| Estimated average cost of standard care per participant in the Control Arm | 2.5 years |
| Estimated average cost of cardiovascular screening per participant in the Test Arm | 2.5 years |