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Individualized care plans in HCT survivors
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Number of transplants; N (%)
1
Myeloablative (including autologous regimens) Non-myeloablative/reduced-intensity
Missing
TBI as part of conditioning regimen; N (%) Yes
No
History of acute GvHD; N (%)*
Yes
No
History of chronic GvHD; N (%)*
Yes
No
Health literacy; N (%)†
Adequate literacy
Possibility of limited literacy
High likelihood of limited literacy
206 (89)
25 (11)
168 (73) 62 (27) 1 (<1)
49 (21)
182 (79)
70 (63) 41 (37)
67 (60)
44 (40)
154 (74)
36 (17)
18 (9)
191 (84)
36 (16)
176 (78) 50 (22) 1 (<1)
46 (20)
181 (80)
67 (67) 33 (33)
66 (66)
34 (34)
172 (83)
27 (13)
9 (4)
≥2
Conditioning regimen intensity; N (%)
N: number; SCP: Survivorship Care Plan; HCT: hematopoietic cell transplantation; TBI: total body irradiation; GvHD: graft-versus-host disease. *Allogeneic HCT only. †Assessed by Newest Vital Sign instrument; n=208 for SCP arm and n=208 for routine care arm.
quences, and recommendations regarding follow up and preventive care. SCPs are generally accepted as an impor- tant component of cancer survivorship care.36 Randomized trials of SCPs in cancer patients have primarily focused on providing information through in-person visits with patients or educating primary care providers, and evidence of their efficacy in enhancing various aspects of cancer sur- vivorship care is generally negative.37 They are also fre- quently underused. This may be due to a variety of rea- sons, including insufficient resources for their generation and implementation, and a paucity of evidence regarding an impact on patient outcomes.38-42 The use and the dis- semination of SCPs in HCT survivors are hampered by similar challenges, and many transplant centers do not routinely provide patients with this tool. Furthermore, these barriers may be accentuated because of the highly complex nature and unique exposures associated with the transplant procedure and the challenges involved in pro- viding co-ordinated survivorship care.29
We hypothesized that a patient-centered approach with a personalized SCP based on published guidelines for the prevention of HCT-related late complications,24,25 and gen- erated using patient data routinely submitted by US trans- plant centers to an international clinical outcomes registry [Center for International Blood and Marrow Transplant Research (CIBMTR)], would increase patient awareness of recommended preventive care, which in turn would reduce distress, promote healthy behaviors, enhance healthcare utilization for appropriate preventive care, and improve health-related quality of life (HRQOL). By using existing CIBMTR data, this approach would overcome several system-level barriers to providing survivorship care through transplant centers. Furthermore, it could serve as a template for a general, efficient mechanism for providing a patient-centric SCP to long-term HCT sur- vivors who frequently are no longer under the care of
transplant centers and are particularly vulnerable to gaps in preventive care. In a multicenter randomized controlled trial (RCT), we evaluated the efficacy of such an individu- alized SCP instrument generated using registry data and mailed to patients versus standard care on improving patient-reported outcomes in adult HCT survivors 1-5 years after their transplant.
Methods
Potentially eligible patients from 17 participating US centers were identified from the CIBMTR database, and paper-based SCPs personalized to HCT specific exposures were generated using CIBMTR data for patients who consented and enrolled on the study (see Online Supplementary Methods).43 Patient eligibility criteria were kept broad and included patients who were 1-5 years post transplant, ≥18 years at the time of HCT, with no evidence of disease relapse/progression or second cancers, and fluency in English; patients were eligible irrespective of transplant type (autologous or allogeneic), diagnosis, donor source or conditioning regimen. None of the participating centers had an existing mech- anism for routinely providing SCPs to their patients. The RCT used a multi-center design with patient-level randomization to treatment (Figure 1), and was approved by Institutional Review Boards at the National Marrow Donor Program (NMDP) and each participating site. A random order list of survivors was generated and released in blocks to centers, who confirmed patient survival and accuracy of SCP-related data. Centers contacted patients and obtained their consent to the study, and then informed the CIBMTR, who proceeded with the rest of the study procedures. The CIBMTR Survey Research Group (SRG) conducted a phone assessment within 30 days of the patient receiving the participant enrollment form. Patients were randomized 1:1 to the SCP or con- trol arm (with delayed SCP). Patients randomized to the SCP arm received an informative letter by express post and their printed
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