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Rates and Predictors of Nonadherence to the Post Allogeneic Hematopoietic Cell Transplant Medical Regimen in Patients and Caregivers

Transplant Cell Ther

2021 Karen Syrjala

BACKGROUND: Allogeneic hematopoietic cell transplant (HCT) requires a complex, multicomponent medical regimen after hospital discharge. Patients must manage multiple medications, care for their catheter, minimize exposure to sources of potential infection, follow diet, exercise, and self-care guidelines, and attend frequent follow up medical appointments. Their caregivers are tasked with helping them manage the regimen. Despite its importance in preventing adverse clinical outcomes, there has been little study of regimen nonadherence and its predictors. OBJECTIVES: We sought to prospectively determine rates and predictors of nonadherence to components of the post-HCT medical regimen during the first 8 weeks after hospital discharge. STUDY DESIGN: Patients (n=92) and their caregivers (n=91) (total N=183) completed interview assessments pre-HCT, and 4- and 8-weeks after hospital discharge post-HCT. Sociodemographic factors (e.g., age, sex); patient clinical status (e.g., disease type, donor type); patient and caregiver self-reported health-related factors (e.g., medical comorbidities); and patient and caregiver psychosocial factors (e.g., anxiety, depression, HCT task specific and general self-efficacy, relationship quality) were assessed pre-HCT. Nonadherence to each of 17 regimen tasks was assessed at 4- and 8-weeks post hospital discharge via self- and caregiver collateral report. RESULTS: Nonadherence rates varied among tasks, with 11.2-15.7% of the sample reporting nonadherence to immunosuppressant medication, 34.8-38.6% to other types of medications, 14.6-67.4% to required infection precautions, and 27.0-68.5% to lifestyle-related behaviors (e.g., diet/exercise). Nonadherence rates were generally stable but worsened over time for lifestyle-related behaviors. The most consistent nonadherence predictors were patient and caregiver pre-HCT perceptions of lower HCT task efficacy. Higher caregiver depression, caregiver perceptions of poorer relationship with the patient, having a non-spousal caregiver, and having non-AML disease also predicted greater nonadherence in one or more areas. CONCLUSIONS: Rates of nonadherence vary across tasks and both patient and caregiver factors, particularly self-efficacy, predicted nonadherence. The findings highlight the importance of considering not only patient but caregiver factors in post-HCT regimen nonadherence.

A Pilot Randomized Controlled Trial of a Fitbit- and Facebook-Based Physical Activity Intervention for Young Adult Cancer Survivors

J Adolesc Young Adult Oncol

2021 K. Scott Baker; Jason Mendoza; Eric Chow; Karen Syrjala

Purpose: Most young adult cancer survivors (YACS) do not meet physical activity (PA) guidelines. Although PA can improve health and quality of life (QOL), few randomized controlled trials (RCTs) of PA interventions for YACS exist. We conducted a pilot RCT to test feasibility of a PA intervention among YACS. Methods: We recruited 18-39-year-olds (≥1 and <5 years postcancer therapy) from Seattle Cancer Care Alliance. The 12-week intervention involved a wrist-worn PA-tracking device (Fitbit), a peer-based Facebook support group, step count goal setting, and a self-selected support "buddy." Controls received Fitbit only. Baseline assessments occurred before randomization; follow-up assessments occurred during intervention weeks 10-12. Feasibility criteria are listed below. Exploratory outcomes included PA, sedentary time (ST), QOL measures (e.g., fatigue), and self-determination theory (SDT) construct measures. Results: All feasibility criteria were met: We recruited 50 YACS, intervention participants wore the Fitbit on the majority of intervention days (82.9%), ≥75% of participants completed questionnaires at baseline (100%) and follow-up (93.9%). Exploratory analyses, adjusted for wave, accelerometer wear time, race, and income, showed significant group differences for change in ST (-52.4 vs. 2.5 minutes/day; p = 0.002) but no change in moderate-to-vigorous intensity PA (0.0 vs. -0.2 minutes/day; p = 0.40), comparing intervention participants to controls. The intervention (vs. control) group had a greater increase in fatigue interference (p = 0.03). No other significant differences in SDT or QOL measures were found. Conclusion: This Fitbit and Facebook-based PA intervention was feasible to YACS, with promising effects on reducing ST, and warrants a fully powered RCT. Clinical Trial Registration no.: NCT03233581.

Cancer survivorship care for young adults: a risk-stratified, multicenter randomized controlled trial to improve symptoms

J Cancer Surviv

2021 Emily Artim; Casey Walsh; Jenna Voutsinas; Wendy Leisenring; K. Scott Baker; Jean Yi; Karen Syrjala

PURPOSE: Young adult (YA) cancer survivors have high rates of adverse health and psychosocial outcomes. This risk-stratified, multicenter, randomized controlled trial (RCT) compared a self-management survivorship intervention to usual care in YA survivors with symptoms of cancer-related distress, insomnia, fatigue, pain, and/or depression. METHODS: Eligibility included age 18-39 at diagnosis with an invasive malignancy in the previous 1-5years. Baseline assessment determined "high need" participants, with 2-5 elevated targeted symptoms. We randomized high need participants to intervention or usual care and offered intervention participants a survivorship clinic visit, which included mutually decided action plans for symptoms. Follow-up calls at 1 and 3months after the clinic visit reviewed action plan progress. Outcomes compared rates of improved symptoms for intervention vs usual care at 6months and 12months. RESULTS: N=344 completed baseline assessment, with n=147 (43%) categorized as high need and randomized. Of n=73 randomized to the intervention, n=42 (58%) did not attend their survivorship clinic visit. In intent-to-treat analyses, aggregate symptom scores did not differ between arms, though distress improved for 46% in the intervention arm at 6months compared to 18% in usual care (p=0.03) among those with elevated distress at baseline. CONCLUSIONS: Distress improved for YAs who received self-management survivorship care. However, the study demonstrates a need for alternative strategies for providing YA survivorship care. TRIAL REGISTRATION: NCT02192333 IMPLICATIONS FOR CANCER SURVIVORS: While YA survivors demonstrate some improved distress when provided survivorship care, to make care accessible and effective, they require options such as remote delivery of care.

A SMART approach to optimizing delivery of an mHealth intervention among cancer survivors with posttraumatic stress symptoms

Contemp Clin Trials

2021 Karen Syrjala

BACKGROUND/AIMS: Many cancer survivors who received intensive treatment such as hematopoietic stem cell transplantation (HCT) experience posttraumatic stress disorder (PTSD) symptoms. PTSD is associated with lower quality of life and other symptoms that require clinical treatment. The iterative treatment decisions that happen in clinical practice are not adequately represented in traditional randomized controlled trials (RCT) of PTSD treatments. The proposed stepped-care SMART design allows for evaluation of initial response to the Cancer Distress Coach mobile app; adaptive stepped-care interventions; and precision treatment strategies that tailor treatment selection to patient characteristics. METHODS/DESIGN: HCT survivors (N=400) reporting PTSD symptoms are being recruited at two cancer centers and randomly assigned to: 1) Cancer Distress Coach app or 2) Usual Care. The app includes educational and cognitive behavioral therapy (CBT)-based activities. Four weeks post-randomization, participants re-rate their PTSD symptoms and, based on intervention response, non-responders are re-randomized to receive video-conferenced sessions with a therapist: 3) coaching sessions in using the mobile app; or 4) CBT specific to HCT survivors. Participants complete outcome measures of PTSD, depression, and anxiety after Months 1, 3, and 6. Participant characteristics moderating intervention responses will be examined. CONCLUSIONS: This novel adaptive trial design will afford evidence that furthers knowledge about optimizing PTSD interventions for HCT survivors. To our knowledge, this study is the first SMART design evaluating PTSD symptom management in cancer survivors. If successful, it could be used to optimize treatment among a range of cancer and other trauma survivors.

Biobehavioral Research and Hematopoietic Stem Cell Transplantation: Expert Review from the Biobehavioral Research Special Interest Group of the American Society for Transplantation and Cellular Therapy

Transplant Cell Ther

2021 Effie Petersdorf; Karen Syrjala

Hematopoietic cell transplantation (HCT) is a potentially curative treatment for many hematologic conditions. Despite advances in conditioning and supportive measures, there remain significant comorbidities that threaten survivorship. Adverse effects of stress-related biobehavioral processes - defined here as the interactions of behavioral, psychological, and socioenvironmental factors with biology - impact immune recovery and function and are particularly salient in the HCT context given the importance of immune reconstitution for improved survivorship. However, biobehavioral processes have been under-investigated in this vulnerable group as compared to other cancer populations. Here, the Biobehavioral Research Special Interest Group (SIG) of the American Society for Transplantation and Cellular Therapy provides an expert review to inform research directions explicating the biological correlates of behavioral symptoms and evaluate the impact of these on HCT outcomes. The goal of this expert review is to provide a foundation for advancing science that effectively integrates behavioral and biological processes to optimize quality of life and improve clinical outcomes for HCT patients.

Survivorship, Version 1.2021 Featured Updates to the NCCN Guidelines

J Natl Compr Canc Netw

2021 Karen Syrjala; K. Scott Baker

The NCCN Guidelines for Survivorship are intended to help healthcare professionals working with cancer survivors to ensure that each survivor's complex and varied needs are addressed. The Guidelines provide screening, evaluation, and treatment recommendations for consequences of adult-onset cancer and its treatment; recommendations to help promote healthful lifestyle behaviors, weight management, and immunizations in survivors; and a framework for care coordination. This article summarizes the recommendations regarding employment and return to work for cancer survivors that were added in the 2021 version of the NCCN Guidelines.

Return to Work Among Young Adult Survivors of Allogeneic Hematopoietic Cell Transplantation in the United States

Transplant Cell Ther

2021 Rachel Salit; Stephanie Lee; Neel Bhatt; K. Scott Baker; Karen Syrjala

BACKGROUND: Young adult (YA) survivors of allogeneic hematopoietic cell transplant (HCT) are at risk for late psychosocial challenges, including inability to return to work post-HCT. However, work-related outcomes in this population remain understudied. OBJECTIVES: To assess the post-HCT work status of survivors of allogeneic HCT who underwent HCT as YA and analyze the patient-, disease-, and HCT-related factors associated with their work status at 1-year post-HCT. STUDY DESIGN: Using the Center for International Blood and Marrow Transplant Research (CIBMTR) data, we described post-HCT work status (full-time, part-time work, unemployed, and medical disability) of YA HCT survivors (N=1365) who underwent HCT between 2008 and 2015. Percentages of work status categories were reported at four timepoints: 6-months, 1-, 2-, and 3-year post-HCT. Percentages of post-HCT work status categories at the 1-year timepoint were also described in relation to survivors' pre-HCT work status categories. Factors associated with 1-year post-HCT work status (full-time or part-time work) were examined using logistic regression. RESULTS: From 6 months to 3 years post-HCT, the percentage of survivors working full-time and part-time increased from 18.3% to 50.7%, and from 6.9% to 10.5%, respectively. Of patients in full-time work pre-HCT, 50% were unemployed or on medical disability at 1-year post-HCT. Female sex (Odds ratio [OR] 0.55; 95% confidence interval [CI] 0.40-0.77), HCT-comorbidity index (HCT-CI) score 3 (OR 0.57; 95% CI 0.39-0.82), pre-HCT unemployment (OR 0.37; 95% CI 0.24-0.56), and medical disability (OR 0.44; 95% CI 0.28-0.70), development of grade 3-4 acute graft vs. host disease (OR 0.52; 95% CI 0.34-0.80), and relapse within one-year post-HCT (OR 0.34; 95% CI 0.21-0.56) were associated with lower likelihood of employment at 1-year post-HCT. Compared to myeloablative conditioning with total body irradiation (TBI), myeloablative conditioning without TBI (OR 1.71; 95% CI 1.16-2.53) was associated with higher likelihood of employment at 1-year post-HCT. Graduate school level education (OR 2.47; 95% CI 1.49-4.10) was also associated with higher likelihood of employment at 1-year post-HCT. CONCLUSIONS: While the work status among YA HCT survivors continued to improve over time, a substantial subset became or remained unemployed or on medical disability. These findings underscore the need for effective return to work supportive interventions in this population.

Social support as a moderator of healthcare adherence and distress in long-term hematopoietic cell transplantation survivors (January, 10.1007/s11764-020-00979-4, 2021)

J Cancer Surviv

2021 Marie-Laure Crouch; Jean Yi; Karen Syrjala; Mary Flowers


Home Spirometry Telemonitoring for Early Detection of Bronchiolitis Obliterans Syndrome in Patients with Chronic Graft-versus-Host Disease

Transplant Cell Ther

2021 Theodore Gooley; Guang-Shing Cheng; Paul Martin; Kelsey Baker; Jesse Hubbard; Jane Turner; Eonji Chung; Stephanie Lee; Karen Syrjala; Michael Boeckh; Mary Flowers; Qianchuan (Chad) He

BACKGROUND: Early detection of bronchiolitis obliterans syndrome (BOS) after allogeneic hematopoietic cell transplantation (HCT) depends upon recognition of subclinical spirometric changes, which is possible only with frequent interval spirometry. OBJECTIVE: We evaluated the feasibility of home monitoring of weekly spirometry via a wireless handheld device and a web monitoring portal in a cohort of high-risk patients for the detection of lung function changes preceding BOS diagnosis. STUDY DESIGN: Observational study of 46 patients with chronic graft-versus-host disease or FEV1 decline of unclear etiology after allogeneic HCT were enrolled to perform weekly home spirometry with a wireless portable spirometer for a year. Measurements were transmitted wirelessly to a cloud-based monitoring portal. Feasibility evaluation included adherence with study procedures and an assessment of the home spirometry measurements compared to laboratory pulmonary function tests. RESULTS: Thirty-six (78%) patients completed one year of weekly monitoring. Overall adherence with weekly home spirometry measurements was 72% (IQR 47-90%), which did not meet the predetermined threshold of 75% for high adherence. Correlation of home FEV1 with laboratory FEV1 was high, with a bias of 0.123 L (Lower limit -0. 294 L, upper limit 0. 541 L), which is within acceptable limits for reliability. Of the 12 individuals who were diagnosed with BOS or suspected BOS during the study period, 9 had antecedent FEV1 decline detected by home spirometry. CONCLUSION: Wireless handheld spirometry performed at home in a high-risk HCT cohort is feasible for close monitoring of pulmonary function and appears to facilitate early detection of BOS.

Social support as a moderator of healthcare adherence and distress in long-term hematopoietic cell transplantation survivors

J Cancer Surviv

2021 Karen Syrjala; Marie-Laure Crouch; Jean Yi; Mary Flowers

BACKGROUND: Treatment with hematopoietic cell transplantation (HCT) has potentially severe effects on physical and psychosocial functioning. Poor social support has been linked with physical morbidity and mortality as well as psychological distress in HCT survivors. This study tested a theory-driven hypothesis that social support buffers adverse effects of health stressors of comorbidities and graft-versus-host disease (cGVHD) on distress and adherence to recommended healthcare among long-term HCT survivors. METHODS: This cross-sectional study analyzed baseline data from a randomized controlled trial in adult survivors 3-18years post-HCT. Data included medical records and patient-reported outcomes including cancer and treatment distress (CTXD), healthcare adherence (HCA), comorbidity index, cGVHD, ENRICHD Social Support Instrument (ESSI), Social Activity Log, and Health Self-Efficacy. We tested hypothesized models for HCA and CTXD using blocked hierarchical linear regressions. RESULTS: Among the 781 HCT survivors completing baseline assessment, 38% had >3 comorbidities, 8% had moderate-severe cGVHD, 30% reported low social support, 30% reported elevated distress, and 49% reported low healthcare adherence. Social support and self-efficacy were directly related to both adherence and distress. Regression models supported the hypothesized moderated relationships for distress but not for healthcare adherence. CONCLUSIONS: The two tested models confirm that the health stressors of comorbidities and cGVHD are moderated by better social support and self-efficacy in their associations with lower distress but without moderating effects for healthcare adherence. IMPLICATIONS FOR CANCER SURVIVORS: Social support and self-efficacy confer protective benefits on healthcare adherence and psychological distress. Interventions are needed that focus on maintaining social networks or finding new networks if necessary. CLINICAL TRIAL REGISTRATION NUMBER: NCT00799461.