Implementing a behavioral physical activity program in children and adolescent survivors of childhood cancer: a pilot randomized controlled trial.

Purpose We aimed to document the acceptability (enrollment rate) and feasibility (phone call delivery rate) of implementing a behavioral PA intervention over 12 weeks, in addition to documenting its effects on patient-reported outcomes and physical functioning. This study also describes the costs of carrying out a behavioral PA intervention. A total of 40 participants were randomized in a 1:1 ratio. The tailored behavioral PA intervention was developed based on the most recent PA guidelines in pediatric oncology and on the COM-B framework to enact PA behavior changes. The prescription (frequency, intensity, time and type (FITT)) was adjusted each week during the weekly support calls. The control group did not receive the intervention. 26 males and 14 females (13.6 years old on average and 2.9 years post-cancer treatment on average) participated in our study. The acceptability rate was 90.9% and the feasibility rate was > 85%. We found that 85% improved PA frequency, 80% improved PA intensity, 100% improved PA time, and 50.0% achieved the recommended PA guidelines. No adverse events were reported over the duration of the intervention. Physical function improved with longer 6-minute walk distances in the intervention group (465.8 ± 74.5 m) than in the control group (398.7 ± 92.9 m) (p = 0.016). PROs scores for all participants were within the limits of the normal range. The estimated cost per participant of carrying out this intervention was USD $126.57. Our 12-week behavioral PA intervention, based on the COM-B framework, was found to be acceptable, feasible and safe in childhood cancer survivors. This study is an important step in the right direction to make exercise standard practice in pediatric oncology.

Exercise oncology clinical trials during treatments: a commentary to address the safety concerns of human subjects regulatory reviewers and committees.

Exercise oncology clinical trials contribute to the advancement of our scientific knowledge and to the safety and care of patients diagnosed with cancer. Nevertheless, regulatory reviewers and committees may not be familiar with the well-documented long-term health benefits and safety of the regular practice of physical activity. Moreover, they may not see how the benefits outweigh the risks in the context where patients diagnosed with cancer are typically seen as vulnerable. Therefore, we would like to provide a purpose-built overview of exercise oncology clinical trials for members involved in institutional review committees, including the Scientific Review Committee (SRC), the Institutional Review Board (IRB), and the Data Safety Monitoring Committee (DSMC) to facilitate a greater understanding of the safety and benefits of physical activity during cancer treatments. Communication is key to improve the success of exercise oncology clinical trials, which are vital for patients diagnosed with cancer.

AYA-UNITE: Lessons Learned on Intervention Development Promoting Social and Physical Health of Adolescent/Young Adult Cancer Survivors.

Adolescent/young adult cancer survivors (AYACS) struggle with poor psychosocial health related to social disruptions due to cancer diagnosis, impacting long-term goal achievement and overall health. In particular, social health promotion is overlooked in AYACS' care. AYA-UNITE, a sociobehavioral exercise intervention pilot for AYACS 15-21 years of age at cancer diagnosis, was designed to foster AYACS' social and physical health. AYA-UNITE was a 12-week group-based virtual exercise program incorporating strength training and aerobic activity. In this brief report, we account AYA-UNITE's conceptual design, lessons learned through AYA-UNITE intervention development, and opportunities for improvement in implementing effective AYACS psychosocial interventions (NCT03778658).

Technology-based supportive care for metastatic breast cancer patients.

PURPOSE: Metastatic breast cancer (MBC) patients are living longer. However, symptom burden remains a significant issue. Technology-based interventions may assist. The purpose of this study was to test a virtual assistant for addressing symptoms in MBC using the Amazon Echo Show with Alexa. METHODS: In this partial crossover randomized trial, the immediate treatment group was exposed to the intervention, called Nurse AMIE (Addressing Metastatic Individuals Everyday) for 6 months. The comparison group was unexposed for the first 3 months and then exposed for 3 months. The randomized controlled trial (RCT) during the first 3 months allowed for the evaluation of intervention effects on symptoms and function. The partial crossover maximized exposure to the intervention for evaluation of feasibility, usability, and satisfaction. RCT outcome data were collected at baseline and 3 months. Feasibility, usability, and satisfaction data were collected throughout the first 3 months of intervention exposure. RESULTS: Forty-two MBC patients were randomized (1:1). Participants were 53 ± 11 years old and 4 ± 7 years from diagnosis with metastatic disease. No significant effects on psychosocial distress, pain, sleep disturbance, fatigue (vitality), quality of life, or chair stands were noted, despite high levels of acceptability (51%), feasibility (65%), and satisfaction (70%). CONCLUSION: A high level of participant acceptability, feasibility, usability, and satisfaction all suggest further research on this platform is warranted. The lack of statistically significant effects on symptoms, quality of life, and function may be the result of small sample size. GOV REGISTRATION NUMBER: NCT04673019 (registration date: December 17, 2020).

Women with metastatic breast cancer don't just follow step-count trends, they exceed them: an exploratory study.

PURPOSE: Metastatic breast cancer (MBC) patients are living longer at the cost of several side effects, affecting their physical and mental health. Physical activity can help women with MBC to improve their wellbeing. Technology-based exercise interventions have shown promising outcomes; however, studies that document their benefits on health behaviors are lacking. Therefore, we aimed to document the impact of virtual assistant technology on enhancing daily step counts in women with MBC. METHODS: A total of 38 women with MBC participated in the 90-day Nurse AMIE (Addressing Metastatic Individuals Everyday) for Amazon Echo Show study, an artificial intelligence-based supportive care intervention. Each day, Nurse AMIE asked four symptom questions (sleep, pain, fatigue, and distress) and daily step counts. Based on participants' answers, an algorithm provided an activity to assist with symptom management. RESULTS: During the first week of the intervention, mean step counts per day were 4935 ± 2884, and during the last week of the intervention, mean step counts per day were 1044 steps higher, for an average of 5979 ± 2651 steps. Non-significant differences were observed between the first and last week (p = 0.211) and between the first and last day (p = 0.099), despite an improvement of 21.2% over time and significant differences between baseline and the other days. CONCLUSION: Women with MBC benefited from the Nurse AMIE for Amazon Echo Show intervention. Despite improvements over time (> 20%), we cannot conclude that the intervention significantly enhanced participants' daily step counts. Larger studies using virtual assistant technologies are required, and this study should be considered a first step in this direction.

Addressing metastatic individuals everyday: Rationale and design of the nurse AMIE for Amazon Echo Show trial among metastatic breast cancer patients.

Background: Metastatic Breast Cancer (MBC) patients often feel their symptom-related needs are unmet, despite visiting their doctors up to once a week. Novel approaches are needed to address symptoms without requiring additional appointments. Technology based symptom management approaches to address symptoms have not been well tested. Methods: Nurse AMIE (Addressing Metastatic Individuals Everyday) is a technology based supportive care platform that provides guideline-concordant symptom management interventions in response to patient reported symptoms. We have previously successfully implemented a tablet version of Nurse AMIE. However, some eligible patients chose not to participate because they were overwhelmed by the technology. To address this barrier, we translated the Nurse AMIE platform to the Amazon Echo Show, which allowed for voice-based interactions. Forty-two MBC patients were randomized 1:1 to receive the Nurse AMIE for Echo Show immediately for six months, or to receive the same intervention for three months, after a three month delay. The primary outcome was change in physical distress over three months, and secondary outcomes included feasibility, acceptability, patient reported outcomes and usability. Conclusions: Results from the Nurse AMIE for Echo Show trial will identify the feasibility, acceptability, and preliminary effects of the Nurse AMIE for Echo Show on patient reported outcomes. Untested novel technologies, particularly voice-based artificial intelligence devices may an effective and scalable vehicle through which we can deliver supportive care interventions. Clinicaltrialsgov identifier: NCT04673019.

Light-intensity and moderate-to-vigorous intensity physical activity among older adult breast cancer survivors with obesity: A narrative review.

BACKGROUND: With an aging population, rising incidence of breast cancer, improved survival rates, and obesity epidemic, there will be a growing population of older adult breast cancer survivors with obesity. This complex population, often with multimorbidity, is at risk for several poor health outcomes, including recurrence, cardiovascular disease, dementia, and diabetes, and a number of deleterious symptoms, including a worsened inflammatory profile, breast cancer- related lymphedema, mobility disability, cognitive impairment, anxiety, and depressive symptoms. A wealth of meta-analytic and randomized controlled trial evidence show that adherence to World Health Organization and 2018 United States Physical Activity guidelines-based levels of moderate-to-vigorous physical activity (MVPA) reduces risk of all-cause mortality, and improves symptoms. However, few survivors engage in recommended levels of MVPA, and symptoms related to their multimorbidity may preclude engaging in sufficient levels of MVPA. Additional research of MVPA in this population is warranted; however, understudied light-intensity physical activity (LIPA) may be a more pragmatic target than MVPA among this complex population facing extensive challenges meeting MVPA recommendations. Large benefits are likely to occur from increasing these survivors' total activity, and LIPA prescriptions may be a more pragmatic approach than MVPA to aid this transition. METHODS: We present a broad, narrative review of the evidence for MVPA and LIPA in this population on an array of health outcomes across the translational science spectrum (clinical, implementation, and public health), and identify a number of directions for future research focused on understanding the potential diverse health effects of LIPA. CONCLUSION: Additional LIPA research is warranted, as LIPA prescriptions may be a pragmatic strategy to effectively promote physical activity to this complex population.

Cost evaluation of an exercise oncology intervention: The exercise in all chemotherapy trial.

BACKGROUND: There is strong evidence supporting the efficacy of exercise oncology programs to improve physical and psychosocial outcomes during active treatment. However, there is a paucity of evidence on the effect of exercise on healthcare utilization and cost analyzes of exercise oncology programs. AIMS: Our objective was to assess the effects of a pragmatic exercise oncology program (ENACT) during active chemotherapy treatment on healthcare utilization and associated costs. METHODS: We conducted post-hoc analyzes on 160 ENACT participants and 75 comparison participants matched on cancer site, stage, age range, and gender. We obtained complete healthcare utilization histories for each patient (specific to emergency department [ED] visits and hospital admissions) coinciding with their participation in ENACT. A sub-analysis was conducted for advanced stage breast, gastrointestinal, and pancreatic cancer patients. RESULTS: Healthcare costs for patients who participated in the ENACT exercise oncology intervention were numerically lower than healthcare costs for the comparison group, even after accounting for the cost of the intervention. However, the differences were not statistically significant. CONCLUSION: Our findings suggest that an exercise oncology program during active chemotherapy treatment are at least cost neutral for all cancer patients, including advanced stage cancers. Additional research is warranted to evaluate the potential for exercise oncology programs to reduce healthcare utilization, particularly in advanced cancer patients.

Testing the acceptability and feasibility of a tablet-based supportive cancer platform for patients with metastatic breast cancer.

BACKGROUND: Although metastatic breast cancer (MBC) survival is improving, symptoms remain a significant burden. Returning to a cancer center for symptom management can be challenging. Technology-enabled supportive care platforms are worth exploration. METHODS: Seventeen patients with MBC were randomized to immediate or delayed start for a 3-month intervention that included daily tablet-based guideline-concordant self-care for pain, distress, fatigue, and sleep disturbance, as well as weekly calls with a patient navigator. The primary outcome was patient acceptability. We also assessed feasibility, patient satisfaction, and cost and compared between group differences for symptoms. RM-ANOVA examined between group differences over time. Hedges' d effect sizes quantified magnitude of differences in change between immediate and delayed start. RESULTS: Sixty-eight percent of patients approached accepted the tablet-based intervention. Patients interacted with the tablet 48% of possible days. Patient satisfaction ranged from 83 for walking to 49% for the psychological interventions. The cost of delivering Nurse AMIE for 3 months was $570.23. Small nonsignificant improvements were found for fatigue (d=0.24). Nonsignificant, but potentially clinically meaningful, moderate reductions were found for sleep (d=0.65) and distress (d=0.74). DISCUSSION: A tablet-based supportive care platform that offers guideline-concordant self-care for pain, fatigue, sleep, and distress was observed to be highly acceptable and feasible for patients with metastatic breast cancer. Patient satisfaction scores and initial evaluation of efficacy are promising, and the platform warrants further investigation. IMPLICATIONS FOR CANCER SURVIVORS: Technology-based self-care is a promising option to address symptoms in patients with metastatic breast cancer.

The exercise in all chemotherapy trial.

BACKGROUND: Multiple international organizations have called for exercise to become standard practice in the setting of oncology care. The feasibility of integrating exercise within systemic chemotherapy has not been investigated. METHODS: Patients slated to receive infusion therapy between April 2017 and October 2018 were screened for possible inclusion. The study goal was to establish the acceptability and feasibility of embedding an exercise professional into the chemotherapy infusion suite as a method of making exercise a standard part of cancer care. The exercise prescriptions provided to patients were individualized according to results of brief baseline functional testing. RESULTS: In all, 544 patients were screened, and their respective treating oncologists deemed 83% of them to be medically eligible to participate. After further eligibility screening, 226 patients were approached. Nearly 71% of these patients (n = 160) accepted the invitation to participate in the Exercise in All Chemotherapy trial. Feasibility was established because 71%, 55%, 69%, and 63% of the aerobic, resistance, balance, and flexibility exercises prescribed to patients were completed. Qualitative data also supported the acceptability and feasibility of the intervention from the perspective of patients and clinicians. The per-patient cost of the intervention was $190.68 to $382.40. CONCLUSIONS: Embedding an exercise professional into the chemotherapy infusion suite is an acceptable and feasible approach to making exercise standard practice. Moreover, the cost of the intervention is lower than the cost of other common community programs. Future studies should test whether colocating an exercise professional with infusion therapy could reach more patients in comparison with not colocating. LAY SUMMARY: Few studies have tested the implementation of exercise for patients with cancer by embedding an exercise professional directly into the chemotherapy infusion suite. The Exercise in All Chemotherapy trial shows that this approach is both acceptable and feasible from the perspective of clinicians and patients.

Implementing Strength after Breast Cancer (SABC) in outpatient rehabilitation clinics: mapping clinician survey data onto key implementation outcomes.

BACKGROUND: While 3.5 million breast cancer survivors in the USA are indicative of promising disease-free survival, many experience adverse effects in recovering from treatment. Evidence-based exercise programs may be a low-cost, easily disseminable solution to the challenge of recovering from adverse treatment affects. Therefore, after establishing efficacy in a large randomized controlled trial, we developed the Strength after Breast Cancer (SABC) program and the accompanying online course for clinicians interested in physical therapy to learn to deliver this rehabilitative exercise program to individuals with breast cancer. We surveyed clinicians who took the course to assess implementation of the program in outpatient rehabilitation clinics. METHODS: Ninety-six clinicians completed the survey between June and December, 2017 (24% response). Guided by Proctor's implementation outcomes framework, the respondents were asked if they had implemented (adoption) and are still implementing the program (sustainability), and which programmatic components they implemented (fidelity). Respondents were asked how many patients completed the program (reach), how patients got into the program (reach), the program's delivery format (appropriateness), and whether clinics were reimbursed by third-party payers (cost). Finally, respondents were asked what barriers they faced in delivery of SABC (feasibility) and whether others in the clinic completed the course (penetration). RESULTS: Seventy-six percent of respondents implemented SABC and among those, 93% (68/73) were still delivering it. All programmatic components were implemented by over two thirds of respondents (67-95%). On average, the program was delivered to 13 patients per clinic by the time respondents took the survey. Most patient referrals were from oncology clinics (50%). The majority of clinicians delivered SABC one-on-one (96%) and 72% of clinics were compensated via third-party payers. Major barriers were lack of referrals from oncologists (40%) and clinic's competing demands (33%). We found no differences (Fisher's exact test p > .05) in reported barriers between those who implemented the program and those who did not. CONCLUSION: Our findings suggest that the online training was sufficient to successfully implement the SABC program in outpatient rehabilitation clinics with high levels of adoption, fidelity, reach, and capacity for sustainability. Information on patient acceptability, cost-effectiveness, and how to overcome implementation barriers are still needed.

Environmental correlates of physical activity in multiple sclerosis: a cross-sectional study.

BACKGROUND: Multiple sclerosis (MS) is a chronic neurological disease that is associated with physical inactivity. Understanding the factors that correlate with physical activity is important for developing effective physical activity promotion programs for this population. Thus, we conducted a cross-sectional study that examined the association between features of the built environment with self-reported and objectively measured physical activity behaviour in adults with MS. METHODS: Participants with MS (n = 196) were sent a questionnaire packet that included self-report measures of the built environment and physical activity and a pedometer in the mail and were instructed to complete the questionnaires and wear the device for seven days. Participants returned the completed questionnaires in a pre-stamped, pre-addressed envelope. Bivariate correlation analysis was conducted for examining associations between items on the environmental questionnaire with the two measures of physical activity. Stepwise regression analysis was conducted for determining the independent contributions of the significant environmental correlates for explaining variation in physical activity. RESULTS: Correlational analysis indicated that presence of shops, stores, markets or other places within walking distance (r = .20; rho = .18), presence of a transit stop within walking distance (r = .20; rho = .16), and accessibility of free or low-cost recreation facilities (r = .16; rho = .15) were related to pedometer, but not self-reported, measured physical activity. Regression analysis indicated that the presence of a transit stop within walking distance independently explained 4% of variance in pedometer measured physical activity. CONCLUSION: Physical activity is an important behaviour to promote among individuals with MS. This study indicated that aspects of the built environment are related to this health promoting behaviour among those with MS. Further research should focus on the longitudinal relationships among aspects of the environment with physical activity so as to provide strong background for developing effective promotion programs for people with MS.

Brief fruit and vegetable messages integrated within a community physical activity program successfully change behaviour.

BACKGROUND: Consumption of the recommended amounts of fruits and vegetables is associated with several health benefits. Currently less than 25% of the American population meets the minimum recommendation of five servings a day. In order to change this health behaviour, interventions should be based on theory and include community-wide social support. METHODS: A low intensity intervention was developed in which participants (n = 86) were randomly assigned to either the fruit and vegetable intervention (FVI) or standard control condition. The intervention was integrated into an ongoing community physical activity program and study participants were drawn from the sample of community members enrolled in the program. The FVI consisted of brief social cognitive theory-based messages delivered in nine weekly newsletters designed to improve participant outcome and self-efficacy expectations related to fruit and vegetable consumption. RESULTS: Participants in the FVI condition increased in their fruit and vegetable consumption by approximately one to one and one-third servings per day. The control condition showed no change in consumption. The effect of the intervention was enhanced when examined by the extent to which it was adopted by participants (i.e., the number of newsletters read). Those participants who read seven or more newsletters showed an increase of two servings per day. CONCLUSION: This intervention was effective at improving fruit and vegetable consumption among adults. Minimal interventions, such as newsletters, have the ability to reach large audiences and can be integrated into ongoing health promotion programs. As such, they have potential for a strong public health impact.

Participatory research to promote physical activity at congregate-meal sites.

The purpose of this study was to determine the feasibility and effectiveness of an on-site physical activity (PA) program offered with congregate meals. Study 1 surveyed meal-site users on their likelihood to participate. Study 2 used meal-site-manager interviews and site visits to determine organizational feasibility. Study 3, a controlled pilot study, randomized meal sites to a 12-week group-based social-cognitive (GBSC) intervention or a standard-care control. Studies 1 and 2 indicated that most meal-site users would participate in an on-site PA program, and meal sites had well-suited physical resources and strong organizational support for this type of program. In Study 3, GBSC participants increased their weekly PA over those in the control condition (p < .05, ES = .79). Results indicated that changes in task cohesion might have mediated intervention effectiveness. These studies demonstrate that a PA program offered in this venue is feasible, is effective in promoting PA, and could have a strong public health impact.