A longitudinal multidimensional rehabilitation program for patients undergoing allogeneic blood and marrow transplantation (CaRE-4-alloBMT): Protocol for a phase II feasibility pilot randomized controlled trial.

BACKGROUND: Allogeneic blood and marrow transplantation (alloBMT) is a curative treatment for blood cancers associated with various treatment-related adverse events and morbidities. Current rehabilitation programs are limited for patients undergoing alloBMT and research is urgently needed to test the acceptability and effectiveness of these programs. In response, we developed a 6-month multidimensional longitudinal rehabilitation program that spans from pre transplant to 3 months post transplant discharge (CaRE-4-alloBMT). METHODS: This study is a phase II randomized controlled trial (RCT) conducted at the Princess Margaret Cancer Centre in patients undergoing alloBMT. A total of 80 patients stratified by frailty score will be randomized to receive usual care (n = 40) or CaRE-4-alloBMT plus usual care (n = 40). The CaRE-4-alloBMT program includes individualized exercise prescriptions, access to online education through a dedicated self-management platform, wearable technology for remote monitoring, and remote tailored clinical support. Feasibility will be assessed by examining the recruitment and retention rates and adherence to the intervention. Safety events will be monitored. Acceptability of the intervention will be assessed through qualitative interviews. Secondary clinical outcomes will be collected through questionnaires and physiological assessments at baseline (T0, 2-6 weeks pre-transplant), transplant hospital admission (T1), hospital discharge (T2), and 3 months post-discharge (T3). CONCLUSION: This pilot RCT study will determine the feasibility and acceptability of the intervention and study design and will inform full-scale RCT planning.

Implementation of a Novel Electronic Patient-Directed Smoking Cessation Platform for Cancer Patients: Interrupted Time Series Analysis.

BACKGROUND: Continued smoking in cancer patients undergoing treatment results in significantly higher rates of treatment toxicities and persistent effects, increased risk of recurrence and second malignancy, and increased all-cause mortality. Despite this, routine tobacco use screening and the provision of smoking cessation treatment has yet to be implemented widely in the cancer setting. OBJECTIVE: The objective of this study was to implement and evaluate the adoption and impact of an innovative Smoking Cessation e-referral System (CEASE) to promote referrals to smoking cessation programs in cancer patients. METHODS: A patient-directed electronic smoking cessation platform (CEASE) was developed to promote smoking screening and referral and implemented at 1 of Canada's largest cancer centers. The implementation and evaluation were guided by the Ottawa Model of Research Use. An interrupted time series design was used to examine the impact of CEASE on screening rates, referrals offered, and referrals accepted compared with a previous paper-based screening program. A subsample of smokers or recent quitters was also assessed and compared pre- and postimplementation to examine the effect of CEASE on subsequent contact with smoking cessation programs and quit attempts. RESULTS: A total of 17,842 new patients attended clinics over the 20-month study period. The CEASE platform was successfully implemented across all disease sites. Screening rates increased from 44.28% (2366/5343) using the paper-based approach to 65.72% (3538/5383) using CEASE (P<.01), and referrals offered to smokers who indicated interest in quitting increased from 18.6% (58/311) to 98.8% (421/426; P<.01). Accepted referrals decreased from 41% (24/58) to 20.4% (86/421), though the overall proportion of referrals generated from total current/recent tobacco users willing to quit increased from 5.8% (24/414) to 20.2% (86/426) due to the increase in referrals offered. At 1-month postscreening, there was no significant difference in the proportion that was currently using tobacco and had not changed use in the past 4 weeks (pre: 28.9% [24/83] and post: 28.8% [83/288]). However, contact with the referral program increased from 0% to 78% in the postCEASE cohort (P<.001). CONCLUSIONS: CEASE is an innovative tool to improve smoking screening and can be implemented in both a time- and cost-effective manner which promotes sustainability. CEASE was successfully implemented across all clinics and resulted in improvements in overall screening and referral rates and engagement with referral services.

Smartphone-Enabled Health Coaching Intervention (iMOVE) to Promote Long-Term Maintenance of Physical Activity in Breast Cancer Survivors: Protocol for a Feasibility Pilot Randomized Controlled Trial.

BACKGROUND: Although physical activity has been shown to contribute to long-term disease control and health in breast cancer survivors, a majority of breast cancer survivors do not meet physical activity guidelines. Past research has focused on promoting physical activity components for short-term breast cancer survivor benefits, but insufficient attention has been devoted to long-term outcomes and sustained exercise adherence. We are assessing a health coach intervention (iMOVE) that uses mobile technology to increase and sustain physical activity maintenance in initially inactive breast cancer survivors. OBJECTIVE: This pilot randomized controlled trial (RCT) is an initial step in evaluating the iMOVE intervention and will inform development of a full-scale pragmatic RCT. METHODS: We will enroll 107 physically inactive breast cancer survivors and randomly assign them to intervention or control groups at the University Health Network, a tertiary cancer care center in Toronto, Canada. Participants will be women (age 18 to 74 years) stratified by age (55 years and older/younger than 55 years) and adjuvant hormone therapy (AHT) exposure (AHT vs no AHT) following breast cancer treatment with no metastases or recurrence who report less than 60 minutes of preplanned physical activity per week. Both intervention and control groups receive the 12-week physical activity program with weekly group sessions and an individualized, progressive, home-based exercise program. The intervention group will additionally receive (1) 10 telephone-based health coaching sessions, (2) smartphone with data plan, if needed, (3) supportive health tracking software (Connected Wellness, NexJ Health Inc), and (4) a wearable step-counting device linked to a smartphone program. RESULTS: We will be assessing recruitment rates; acceptability reflected in selective, semistructured interviews; and enrollment, retention, and adherence quantitative intervention markers as pilot outcome measures. The primary clinical outcome will be directly measured peak oxygen consumption. Secondary clinical outcomes include health-related quality of life and anthropometric measures. All outcome measures are administered at baseline, after exercise program (month 3), and 6 months after program (month 9). CONCLUSIONS: This pilot RCT will inform full-scale RCT planning. We will assess pilot procedures and interventions and collect preliminary effect estimates. TRIAL REGISTRATION: ClinicalTrials.gov NCT02620735; https://clinicaltrials.gov/ct2/show/NCT02620735 (Archived by WebCite at https://clinicaltrials.gov/ct2/show/NCT02620735).

Retinal and Optic Nerve Hemorrhages in the Newborn Infant: One-Year Results of the Newborn Eye Screen Test Study.

PURPOSE: To report the birth prevalence, risk factors, characteristics, and location of fundus hemorrhages (FHs) of the retina and optic nerve present in newborns at birth. DESIGN: Prospective cohort study at Stanford University School of Medicine. PARTICIPANTS: All infants who were 37 weeks postmenstrual age or older and stable were eligible for screening. Infants with known or suspected infectious conjunctivitis were excluded. METHODS: Infants born at Lucile Packard Children's Hospital (LPCH) from July 25, 2013, through July 25, 2014, were offered universal newborn screening via wide-angle digital retinal photography in the Newborn Eye Screen Test study. Maternal, obstetric, and neonatal factors were obtained from hospital records. The location, retinal layer, and laterality of FH were recorded by 1 pediatric vitreoretinal specialist. MAIN OUTCOME MEASURES: Birth prevalence of FH. Secondary outcomes included rate of adverse events, risk factors for FH, hemorrhage characteristics, and adverse events. RESULTS: The birth prevalence of FH in this study was 20.3% (41/202 infants). Ninety-five percent of FHs involved the periphery, 83% involved the macula, and 71% involved multiple layers of the retina. The fovea was involved in 15% of FH cases (birth prevalence, 3.0%). No cases of bilateral foveal hemorrhage were found. Fundus hemorrhages were more common in the left eye than the right. Fundus hemorrhages were most commonly optic nerve flame hemorrhages (48%) and white-centered retinal hemorrhages (30%). Retinal hemorrhages were found most frequently in all 4 quadrants (35%) and more often were multiple than solitary. Macular hemorrhages most often were intraretinal (40%). Among the risk factors examined in this study, vaginal delivery compared with cesarean section (odds ratio [OR], 9.34; 95% confidence interval [CI], 2.57-33.97) showed the greatest level of association with FH. Self-identified ethnicity as Hispanic or Latino showed a protective effect (OR, 0.43; 95% CI, 0.20-0.94). Other study factors were not significant. CONCLUSIONS: Fundus hemorrhages are common among newborns. They often involve multiple areas and layers of the retina. Vaginal delivery was associated with a significantly increased risk of FH, whereas self-identified Hispanic or Latino ethnicity was protective against FH in this study. The long-term consequences of FH on visual development remain unknown.

Examination of couples' attachment security in relation to depression and hopelessness in maritally distressed patients facing end-stage cancer and their spouse caregivers: a buffer or facilitator of psychosocial distress?

PURPOSE: The purpose of this study is to determine levels of depression and hopelessness and to explore the relationship between attachment security and psychosocial distress in patients with metastatic/recurrent cancer and spouse-caregivers, experiencing marital distress. METHODS: Couple-participants were from a pilot study and a larger clinical trial prior to randomization. Participation required that one partner endorsed marital distress on the Revised Dyadic Adjustment Scale (RDAS). Outcome measures included the Beck Depression Inventory-II (BDI-II), Beck Hopelessness Scale (BHS), and Experiences in Close Relationships Inventory. RESULTS: Caregivers, compared with their matched ill-partners, had significantly higher scores on the RDAS (distressed). CONCLUSIONS: Marital distress may be amplified within insecure attachment bonds, especially among avoidant male patients and their female caregivers, which may influence caregiving/care-receiving. We offer unique, preliminary support for identifying couples at risk to help reduce suffering and complicated bereavement in the terminal cancer population. Further research that include larger studies, are needed to determine relationships among attachment and psychosocial outcomes.