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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| National Marrow Donor Program | OTHER |
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This randomized study will compare a personalized Survivorship Care Plan (SCP) template with usual care (no SCP). The investigators hypothesize that the personalized SCP that incorporates patient specific treatment exposures and provides a framework for long term followup based on those exposures and subsequent risks for late complications will enhance patient survivorship confidence in knowledge, increase adherence to recommended healthcare, improve health behaviors and reduce HCT-related emotional distress.
This randomized study will compare a personalized Survivorship Care Plan (SCP) template with usual care (no SCP). The investigators hypothesize that the personalized SCP that incorporates patient specific treatment exposures and provides a framework for long term followup based on those exposures and subsequent risks for late complications will enhance patient survivorship confidence in knowledge, increase adherence to recommended healthcare, improve health behaviors and reduce hematopoietic cell transplant (HCT) - related emotional distress.
The randomized study design will be able to evaluate the efficacy of individualized SCP in enhancing transplant survivor knowledge, health behaviors and health care utilization for recommended preventive care. Most transplant centers do not use a standardized SCP for their HCT recipients, and hence, the control arm would represent prevalent standard of care (e.g., discharge summary, provider-to-provider communication).
Transplant centers that will participate in this study will represent a spectrum of center types (e.g., geographic location, center volume, resources and infrastructure) and patient populations (e.g., healthcare disparities, urban/rural population, distance from transplant center). Usual care for each center will be documented at the time of determining center eligibility. The study principal investigators, in consultation with the protocol team, will make the determination about center eligibility after reviewing the centers "usual care" procedures. In order to avoid contamination of the study intervention, centers will be asked not to change their follow-up practices for the period they are enrolling patients on the study.
The primary objective of the investigators study is to evaluate the impact of an individualized SCP on survivor knowledge about past diagnostic and treatment details, confidence in knowledge about prevention and treatment of late-effects, access to resources and familial risk of cancer. For this objective, the investigators will compare the change in score on the Confidence in Survivorship Information instrument from baseline to 6 months after the study intervention.
Secondary objectives will investigate the influence of individualized SCP on standardized measures of HCT related distress, knowledge of recommended care, health behaviors, self-efficacy, and health care utilization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individualized Survivorship Care Plan (SCP) | Experimental |
|
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| Usual care (no SCP) | No Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individualized Survivorship Care Plan (SCP) | Other | The individualized SCP incorporates patient specific treatment exposures and provides a framework for long term followup based on those exposures and subsequent risks for late complications. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Confidence in Survivorship Information instrument score | baseline to 6 months after the study intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HCT treatment distress instrument score | baseline to 6 months after the study intervention | |
| Change in Health behaviors instrument score | baseline to 6 months after the study intervention |
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Inclusion Criteria:
Exclusion Criteria:
- Patients who have received their transplant at a different transplant center will not be eligible for the study
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Murphy, EdD, RN | National Marrow Donor Program | Study Chair |
| Navneet Majhail, MD, MS | Cleveland Clinic Foundation; National Marrow Donor Program | Study Chair |
| K Scott Baker, MD, MS | Fred Hutchinson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Scottsdale | Arizona | 85259-5499 | United States | ||
| University of Florida, Shands Hospital |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 28, 2018 | |
| Reset | Oct 8, 2018 |
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| Changes in Healthcare utilization instrument score | baseline to 6 months after the study intervention |
| Change in Knowledge about transplant exposures instrument score | baseline to 6 months after the study intervention |
| Change in Quality of life instrument score | baseline to 6 months after the study intervention |
| Change in Self-efficacy instrument score | baseline to 6 months after the study intervention |
| Gainesville |
| Florida |
| 32608 |
| United States |
| Loyola Medical Center | Maywood | Illinois | 60153 | United States |
| University of Kansas Cancer Center | Westwood | Kansas | 66205 | United States |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| University of Minnesota Medical Center | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| UNC Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 28, 2018 | Oct 8, 2018 |