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Randomized controlled trial of individualized treatment summary and survivorship care plans for hematopoietic cell transplantation survivors.

ABSTRACT: Survivorship Care Plans (SCPs) may facilitate long-term care for cancer survivors, but their effectiveness has not been established in hematopoietic cell transplantation recipients. We evaluated the impact of individualized SCPs on patient-reported outcomes among transplant survivors. Adult (≥18 years at transplant) survivors who were 1-5 years post transplantation, proficient in English, and without relapse or secondary cancers were eligible for this multicenter randomized trial. SCPs were developed based on risk-factors and treatment exposures using patient data routinely submitted by transplant centers to the Center for International Blood and Marrow Transplant Research and published guidelines for long-term follow up of transplant survivors. Phone surveys assessing patient-reported outcomes were conducted at baseline and at 6 months. The primary end point was confidence in survivorship information, and secondary end points included cancer and treatment distress, knowledge of transplant exposures, health care utilization, and health-related quality of life. Of 495 patients enrolled, 458 completed a baseline survey and were randomized (care plan=231, standard care=227); 200 (87%) and 199 (88%) completed the 6-month assessments, respectively. Patients' characteristics were similar in the two arms. Participants on the care plan arm reported significantly lower distress scores at 6 months and an increase in the Mental Component Summary quality of life score assessed by the Short Form 12 (SF-12) instrument. No effect was observed on the end point of confidence in survivorship information or other secondary outcomes. Provision of individualized SCPs generated using registry data was associated with reduced distress and improved mental domain of quality of life among 1-5 year hematopoietic cell transplantation survivors. Trial registered at clinicaltrials.gov 02200133.

SUBMITTER: Majhail NS

PROVIDER: S-EPMC6518896 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Randomized controlled trial of individualized treatment summary and survivorship care plans for hematopoietic cell transplantation survivors.

Majhail Navneet S NS Murphy Elizabeth E Laud Purushottam P Preussler Jaime M JM Denzen Ellen M EM Abetti Beatrice B Adams Alexia A Besser RaeAnne R Burns Linda J LJ Cerny Jan J Drexler Rebecca R Hahn Theresa T Idossa Lensa L Jahagirdar Balkrishna B Kamani Naynesh N Loren Alison A Mattila Deborah D McGuirk Joseph J Moore Heather H Reynolds Jana J Saber Wael W Salazar Lizette L Schatz Barry B Stiff Patrick P Wingard John R JR Syrjala Karen L KL Baker K Scott KS

Haematologica 20181204 5

Survivorship Care Plans (SCPs) may facilitate long-term care for cancer survivors, but their effectiveness has not been established in hematopoietic cell transplantation recipients. We evaluated the impact of individualized SCPs on patient-reported outcomes among transplant survivors. Adult (≥18 years at transplant) survivors who were 1-5 years post transplantation, proficient in English, and without relapse or secondary cancers were eligible for this multicenter randomized trial. SCPs were deve ...[more]

PMID: 30514795

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Project description:Purpose The purpose of this study was to examine the effects of a randomized controlled trial (RCT) of treatment summaries and survivorship care plans coupled with a nurse counseling session, primarily on physician implementation of and secondarily on patient adherence to recommended survivorship care, among a low-income population of breast cancer survivors (survivors). Methods We recruited 212 low-income, predominantly Latina (72.6%) survivors with stage 0 to III breast cancer, with an average age of 53 years, from two Los Angeles County public hospitals into an RCT of a survivorship care nurse counseling session coupled with the provision of individualized treatment summaries and survivorship care plans to patients and their health care providers from December 2012 to July 2014. One hundred seven survivors received the experimental intervention, and 105 survivors received usual care. Multiple linear regression analyses were performed to assess intervention effects on physician implementation of and patient adherence to recommended survivorship care. Scales that served as covariables were Knowledge of Survivorship Issues, Perceived Efficacy in Patient-Physician Interactions, and Satisfaction With Care and Information. Results Survivors in the intervention group reported greater physician implementation of recommended breast cancer survivorship care, for example, treatment of depression or hot flashes, than did those in the control group (adjusted difference, 16 ± 5.3; P = .003). Baseline Satisfaction With Care and Information was positively associated with physician implementation (coefficient, 5.2 ± 2.2; P = .02). Being married/partnered (-11.8 ± 4.0; P = .004) and age (-0.5 ± 0.2; P = .028) were negatively associated with patient adherence. Conclusion To our knowledge, this is the first RCT of survivorship care plans to show benefits in clinical outcomes, in this case, showing increased physician implementation of recommended breast cancer survivorship care in the intervention group, compared with the control group.

Project description:BackgroundBreast cancer is the most common form of cancer among American women, accounting for 23% of all cancer survivors nationally. Yet, the availability of adequate resources and tools for supporting breast cancer survivors has not kept up with the rapid advancement in treatment options, resulting in unmet supportive care needs, particularly among low-income and minority populations. This study explores an alternative means of delivering breast cancer survivorship care plans (SCPs), with the aim of improving survivor morbidity, patient knowledge, and self-management of treatment-related symptoms, as well as addressing inconsistencies in follow-up care visits.ObjectiveThe overall goal of this study is to improve the uptake of SCP recommendations via an educational intervention for breast cancer survivors, to improve treatment-related morbidity, patient knowledge, self-management, and adherence to follow-up visits. The specific aims of the study are to (1) evaluate the feasibility of the online SCP, and (2) assess the impact of the online SCP on survivorship outcomes.MethodsWe will enroll 50 breast cancer survivors who have completed initial breast cancer treatment into a 2-armed, randomized, waitlist-controlled pilot trial, and collect data at baseline and 6 months. For the first aim, we will use mixed methods, including surveys and personal interviews among the intervention group, to determine the feasibility of providing an online, interactive SCP (called ACESO) based on the survivors' online user experience and their short-term adoption. For the secondary aim, we will compare the 2 groups to assess the primary outcomes of survivor knowledge, self-efficacy for self-management, perceived peer support, and adherence to SCP-recommended posttreatment follow-up visits to oncology and primary care; and the secondary outcomes of treatment-related morbidity (body weight, fatigue, depression, anxiety, sexual function, distress, and sleep quality). We assess these outcomes by using measurements from validated instruments with robust psychometric properties.ResultsWe have developed and refined the online breast cancer survivorship plan, ACESO, with consultation from breast cancer oncologists, nurses, and survivors. Approval for the study protocol has been obtained from the Institutional Review Board. An advisory board has also been established to provide oversight and recommendations on the conduct of the study. The study will be completed over a period of 2 years.ConclusionsThe results of this pilot study will inform the feasibility and design of a larger-scale pragmatic trial to evaluate the impact of an online breast cancer SCP on treatment-related morbidity and self-efficacy for self-management.International registered report identifier (irrid)PRR1-10.2196/23414.

Project description:The long-term care of hematopoietic stem cell transplantation (HSCT) survivors poses special challenges owing to a myriad of possible chronic and/or late complications. Survivorship care plans (SCPs) have been proposed as tools to communicate information on the late effects of treatment and recommended follow-up care to clinicians and survivors. The primary aims of this study were to determine SCP content and format, as well as to assess the preferred timing of SCP provision following HSCT. HSCT survivors and nontransplantation clinicians (oncologists and primary care physicians) were invited to participate in a survey evaluating the usefulness and utility of a sample HSCT-specific SCP with a treatment summary generated by autopopulation from an electronic health record (EHR). All participating HSCT survivors (n = 29) and clinicians (n = 18) indicated a desire to receive an SCP. More than 85% of the participants perceived information about treatments received, recommended follow-up and health maintenance including vaccinations, survivor and clinician resources, and graft-versus-host disease and other late/chronic side effects to be useful. The majority of survivors also believed that care team contact information was useful. In addition, >85% of survivors and clinicians agreed that the SCP increased their understanding of treatments and chronic/late side effects, improved health care provided, and were satisfied with the SCP and found it understandable and easy to use. The majority of survivors indicated that additional information should be added to the SCP, whereas some clinicians deemed the SCP too long. Survivors preferred to receive the SCP as a paper document at the end of a regular follow-up visit and review it with a cancer clinician, whereas clinicians preferred to receive the SCP through the EHR. These findings will help improve the design of future SCPs for use by HSCT survivors and clinicians. Future work will include leveraging the EHR to ease the burden of creating user-centered documents.

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Randomized controlled trial of individualized treatment summary and survivorship care plans for hematopoietic cell transplantation survivors.

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Randomized controlled trial of individualized treatment summary and survivorship care plans for hematopoietic cell transplantation survivors.

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