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Implementing Exercise in Standard Cancer Care (Bizi Orain Hybrid Exercise Program): Protocol for a Randomized Controlled Trial

Aug 9, 2021

JMIR Research Protocols This paper is in the following e-collection/theme issue: October 08, 2020 . Implementing Exercise in Standard Cancer Care (Bizi Orain Hybrid Exercise Program): Protocol for a Randomized Controlled Trial Implementing Exercise in Standard Cancer Care (Bizi Orain Hybrid Exercise Program): Protocol for a Randomized Controlled Trial Authors of this article: 2Deusto University, Bilbao, Spain Abstract Background: Despite the established benefits of regular exercise for patients with cancer to counteract the deleterious effects of the disease itself and treatment-related adverse effects, most of them do not engage in sufficient levels of physical activity and there is a paucity of data on the integration of efficacious exercise programs that are accessible and generalizable to a large proportion of patients with cancer into routine cancer care. Objective: We intend to examine the effects attributable to the implementation of a community-based exercise program on cardiorespiratory functional capacity and quality of life for patients with cancer. Methods: This will be a hybrid study. In the first experimental phase, patients diagnosed with any type of cancer will be randomized into two parallel groups. One group immediately performs Bizi Orain, a 3-month supervised exercise program (3 times a week), in addition to behavioral counseling in a primary health care setting; the other is a reference group that starts the exercise program 3 months later (delayed treatment). In the second observational phase, the entire cohort of participants will be followed-up for 5 years. Any person diagnosed with cancer in the previous 2 years is eligible for the program. The program evaluation involves the uptake, safety, adherence, and effectiveness assessed after completion of the program and with follow-ups at 3, 6, 12, 24, 36, 48, and 60 months. The primary outcomes of the experimental study, to be compared between groups, are improved physical function and quality of life, whereas overall survival is the main objective of the prospective study. To analyze the association between changes in physical activity levels and overall survival, longitudinal mixed-effects models will be used for repeated follow-up measures. Results: A total of 265 patients have been enrolled into the study since January 2019, with 42 patients from the hematology service and 223 from the oncology service. Conclusions: Bizi Orain is the first population-based exercise program in Spain that will offer more insight into the implementation of feasible, generalizable, and sustainable supportive care services involving structured exercise to extend survival of patients with cancer, improve their physical function and quality of life, and reverse the adverse effects of their disease and related treatments, thereby reducing the clinical burden. Trial Registration: NCT03819595; International Registered Report Identifier (IRRID): DERR1-10.2196/24835 JMIR Res Protoc 2021;10(8):e24835 Introduction Cancer is one of the diseases that causes major public health problems worldwide. The lifetime probability of developing any type of cancer in Spain is 49.9% in men and 32.2% in women [ 1 ]. Currently, increasing incidence rates and decreasing mortality rates due to advances in early detection and treatment have translated to a larger number of people living with cancer. This leads to increased costs of cancer care and a growing burden on health care systems in terms of medical management, cancer surveillance, and supportive care [ 2 ]. The disease itself and the treatments used lead to increases in psychosocial distress and depression, impaired cognitive function, increased levels of pain and fatigue, and a significant reduction in cardiorespiratory fitness and strength, as well as muscle (accelerated sarcopenia and cachexia processes) and bone mass losses, alongside increases in body fat. Consequently, patients with cancer have a poor quality of life and a greater risk of developing comorbidities [ 3 ]. It has been estimated that 30%-50% of cancer cases are preventable by reducing exposure to modifiable risk factors such as a sedentary lifestyle, poor diet, and excess body fat, and hence, these risk factors have become the target of the global strategy for cancer prevention [ 4 , 5 ]. A growing body of evidence has demonstrated that patients with cancer who achieve the minimum of 150 min·wk-1 of moderate or 75 min·wk-1 of vigorous physical activity (PA) levels recommended by the American College of Sports Medicine [ 6 ] and Australian Association for Exercise and Sport Science [ 7 ] experience ~27%-35% lower rates of cancer-related death and recurrence [ 8 ]. Current evidence from experimental studies indicates that exercise reduces tumor growth and cancer-specific mortality in a dose-dependent manner [ 6 ]. To target tumor intrinsic factors, moderate-to-high intensity endurance exercise is better than light exercise [ 9 ]. During exercise, the release of several systemic factors (ie, catecholamines and myokines), sympathetic activation, increased blood flow, shear stress, and increased temperature exert immediate stress on tumor metabolism and homeostasis. Following long-term training, such acute effects lead to reductions in systemic inflammation and oxidative stress, hormone-receptor binding, and adaptations in the modulation of circulating factors (ie, insulin, growth factors, and sex-steroid hormones); they also lead to intratumoral adaptations allowing improved blood perfusion, enhanced immunogenicity, and changes in gene expression and metabolism, which contribute to slower tumor progression and may reduce the ability of cancer cells to form tumors in distant tissues [ 9 , 10 ]. Further, resistance training is particularly important for patients with cancer experiencing loss of muscle mass (ie, sarcopenia or cachexia) during and following treatment [ 11 , 12 ]. This type of training is associated with a 33% lower risk of all-cause death after adjusting for potential confounders, including PA [ 13 ]. Despite the established benefits of exercise for patients with cancer and calls to include it as an integral part of cancer treatment, the chances of this information reaching patients are considerably reduced by the self-reported lack of knowledge among oncologists concerning how to properly promote and prescribe exercise [ 14 , 15 ] and paucity of translation strategies for integrating efficacious exercise programs into routine cancer care [ 16 ]. Unfortunately, only ~13% of patients with cancer meet international PA guidelines objectively measured with accelerometers [ 17 ]. Nonetheless, in recent years, community-based oncological exercise programs have been gaining prominence. LIVESTRONG at the Young Men’s Christian Association (YMCA) [ 18 , 19 ] is a community-based exercise program that has shown sustainable benefits in terms of physical function and self-perceived health. Our previous findings from the “Eficancer” study also indicate that exercising thrice a week during a 12-week individually tailored exercise program conducted at local health centers can improve quality of life and physical function, and these improvements are sustained over time [ 20 ]. Exercise program accessibility remains a challenge in implementing the international PA guidelines, but this challenge could be mitigated with strategies and pathways that connect patients with exercise-related resources and a well-designed behavioral intervention program to counteract the common barriers to exercise faced by patients with cancer during and after first-line treatments [ 21 ]. Further, the long-term effects on the PA levels, physical function, survival, and cost-effectiveness of large-scale community-based programs that are accessible and generalizable to a large proportion of patients with cancer (ie, administered in a standard supportive care setting) are unknown. The main objectives of this study are as follows: to examine the effects attributable to an exercise program on physical function, and quality of life, and adverse effects compared to health habit prescriptions, and to explore whether these effects vary by cancer type, stage and treatments, age, or sex to analyze the association between the actual exercise dose (ie, number of sessions and exercise intensity, objectively measured PA level with accelerometers) and measured outcomes to assess the cost-effectiveness of the program Methods Bizi Orain, which means “live now” in Basque language, is an evidence-based exercise program that adheres to the American College of Sports Medicine guidelines for cancer survivors [ 6 ] and is based on the “Life Now” exercise program for people with cancer delivered in Australia [ 22 ]. The program is administered by the Primary Care Research Unit of Bizkaia-Biocruces Bizkaia Research Institute (PCRUB-BBRI) and Deusto University and is delivered at a network of health centers equipped with Bizi Orain exercise laboratories integrated into the public health system of the Basque Country (Osakidetza). Program Design Bizi Orain is a hybrid two-stage study. During the first 3 months, the study has a parallel-group randomized controlled clinical trial design, where study participants are randomly allocated (1:1) to either the Bizi Orain exercise program in addition to a previously reported behavioral intervention [ 23 , 24 ] for the promotion of healthy habits, or to the Prescribe Vida Saludable (PVS) group (In Spanish, “Prescribe Vida Saludable” means “prescription of healthy habits”) alone. After the postprogram assessments, participants allocated to the PVS group will initiate the Bizi Orain exercise program. Thereafter, a 5-year prospective observational cohort study will be conducted with follow-ups at 3, 6, 12, 24, 36, 48, and 60 months ( Figure 1 ) to (1) examine the long-term clinical effects of PA exposure on overall survival, physical function, and patient-reported outcomes and (2) evaluate the feasibility of Bizi Orain, identifying potential barriers and facilitators for a generalized and sustainable exercise program within standard health care settings. To address this point, a qualitative research study will be conducted involving clinical, research, administrative, and community staff, and patients with cancer. Participants Participant recruitment will last for 2 years starting from January 2019. People with any diagnosis of cancer currently receiving treatment or diagnosed less than 2 years earlier are eligible to participate and they are referred by their hospital oncologist, hematologist, or primary care general practitioner. To minimize the risk of hazards associated with program participation, patients will be excluded if they meet any of the following criteria: (1) neutropenia: absolute neutrophil count<500 mm3; (2) severe anemia: hemoglobin concentration<0.8g/dL; (3) platelet count<50000 μL; or (4) any musculoskeletal, cardiovascular, or neurological disorder that could place the participant at risk of injury or illness resulting from the exercise program (as determined by the patient’s clinician). Numerous approaches are to be adopted to raise awareness about the program including the following: (1) training for oncology clinicians and support staff to facilitate direct referral of patients; (2) distribution of program flyers at hospitals, cancer centers, and community-based organizations as well as events for health professionals and patients; 3) sending information (by email and post) to people who have contacted the regional cancer association and expressed interest in exercise; 4) advertisements and coverage in local media; and 5) posts on the regional cancer association website and social media accounts. Specifically, the hospital’s Department of Oncology has established a system for identifying eligible patients. The oncologists, hematologists, or primary care general practitioners who have identified eligible patients inform them about the study, invite them to participate, and give them a written informed consent form. Once a patient agrees to participate, the clinicians inform the program administrators, and in the case of the hospital specialists, the patient’s general practitioner. Potential participants are able to self-enroll in Bizi Orain by telephoning the program administrators and by direct referral from their clinician. Eligible patients who agree to participate are invited to the baseline assessments. Participants are included in the study once they have signed the informed consent form and baseline data have been collected. Randomization Patients will be centrally randomized by PCRUB-BBRI in a 1:1 ratio into the two study groups. A researcher who is independent of the organization responsible for managing the study will randomly allocate patients to groups using a computer-based random number generator. Evaluation Evaluation of the Bizi Orain exercise program involves measuring the uptake, safety, adherence, and effectiveness of the program. These analyses incorporate elements of the reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework [ 25 ]. Evaluation of the effectiveness of the program involves comparisons among the preprogram, postprogram, and follow-up assessments. The evaluation will be undertaken yearly from the beginning of the recruitment (2019) and will proceed until the target sample size is achieved. Uptake The proportion of people participating in the Bizi Orain exercise program out of all people with cancer in the province of Bizkaia (Basque Country) who are eligible will be reported as the participation rate. People with cancer who register for the program but do not commence their participation will also be reported. The representativeness of the participants will be determined by comparing their demographic and clinical characteristics to those of the people diagnosed with cancer in Bizkaia. Information about cancer diagnoses will be derived from the Basque Health System Registry (Osabide). Safety The incidence and severity of any adverse events (ie, falls, muscle strains) that occur during the health center–based sessions will be monitored and reported by the supervising exercise physiologist/nurse using program-specific documentation. Additionally, participants will be asked to self-report the incidence and severity of any adverse events they experience during health center–based sessions or home-based exercise using program-specific documentation. Adherence Attendance at health-center–based exercise sessions and the reason for any missed sessions will be tracked throughout the program. Adherence to the recommended amounts of PA for cancer survivors [ 26 ] is to be assessed by 7-day accelerometer recordings obtained from a randomly selected subset of the participants. Further, completion of assessments at preprogram and postprogram time points as well as follow-up questionnaires will be reported. Compliance with the Bizi Orain exercise program procedures by exercise physiologists/nurseries at each site will be monitored through evaluation of program documentation (ie, screening, assessment, and exercise prescription documents). Effectiveness: Primary Study Outcomes Physical Function (Clinical) Physical function is assessed by 400-m walk tests in a 20-m corridor, repeated chair stand tests (5 times), and handgrip dynamometry tests [ 27 - 29 ]. Each participant will perform a graded submaximal cardiopulmonary exercise test (CPET) on an electric braking cycle-ergometer (ergoline GmbH, ergoselect 4) in the laboratory of the University of Deusto in a controlled environment (temperature, ±21 ºC; relative humidity, 50%-55%; barometric pressure, ±720 mm Hg). Briefly, the test protocol involves an unloaded 5-min warm-up followed by 1-min stages with 10-W workload increments from an initial workload of 20 W [ 30 ]. Participants will be asked to maintain a steady cadence between 60 to 70 rpm. Gas exchange will be recorded breath by breath using a CPET machine (Geratherm Ergostik). The test is performed until confirmation of at least one of the following criteria: (1) The second ventilatory threshold or the so-called “respiratory compensation point” (RCP) is observed from the Wasserman figures (respiratory equivalents, and O2 and CO2 partial pressure changes). (2) The respiration exchange ratio (RER)>=1.05 and rating of perceived effort (RPE)>8 on the 0-10–point Borg scale [ 31 ]. (3) Participants exhibit volitional exhaustion without meeting the previous criteria. From a pragmatic viewpoint and owing to the difficulties of performing a CPET in a community-based program setting, the results obtained from the CPET will not be used for individualized prescriptions of exercise intensity during the sessions. However, these results (ventilatory threshold heart rates) will be used to evaluate the actual exercise intensity undertaken by participants when following a standard exercise prescription based on simpler cost-effective methods like RPE and estimated heart rate reserve (HRR). The maximal strength in the upper and lower body will be measured in terms of the 5-repetition maximum (5RM) (the maximum load that can be lifted five times) in chest and leg press exercises, respectively [ 32 ]. These assessments are to be conducted by an independent exercise physiologist not involved with administering the exercise intervention. Patient-Reported Outcomes (Clinical) A series of questionnaires with sound psychometric properties are to be used to assess general health and cancer-specific quality of life and cancer-related fatigue. The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) is used to assess general health-related quality of life status across physical functioning, physical role functioning, bodily pain, general health, vitality, social functioning, emotional role functioning, and mental health domains (higher scores indicating a greater quality of life) [ 33 ]. Cancer-specific quality of life is evaluated by the core quality of life (QLQ-C-30) questionnaire developed by the European Organization for Research and Treatment of Cancer (EORTC) [ 34 ]. This questionnaire includes five functional domains (physical, role, cognitive, emotional, and social, with higher scores representing greater function/quality of life) and three symptom scales (fatigue, pain, and nausea, with lower scores indicating greater quality of life/less symptom severity). The General Health Questionnaire (GHQ-12) is administered to assess the psychological morbidity and possible psychiatric disorders [ 35 ]. Cancer-related fatigue is assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale [ 36 ]. Finally, the Spanish version of the Alcohol Use Disorders Identification Test (AUDIT) is administered to screen for harmful alcohol consumption [ 37 ]. Overall Survival (Prospective Observations) To assess survival, patients will be followed-up for 5 years. Overall survival will be measured from the time of randomization until death. Medical records and death certificates will be reviewed every year to obtain the survival status. The cause of death will be determined by reviewing medical and death records. Effectiveness: Secondary Study Outcomes Anthropometry and Body Composition The height will be measured using a wall stadiometer (Seca) and body composition with a bioimpedance analyzer (Inbody 770, In-Bldg). The participants will be seated in a quiet room for measuring the resting heart rate and blood pressure. Blood Samples A derivatives of reactive oxygen metabolites (d-ROMS) test will be performed to assess the levels of oxidative stress in the patients [ 38 ]. PA Levels All patients randomly selected to have their PA assessed will be asked to wear an accelerometer (DynaPort MoveMonitor; McRoberts BV) for a full week. This will be fitted around the waist, with the sensor at the middle of the lower back, and should be worn throughout the waking hours, except during water-related activities (ie, swimming and showering). Further, patients are asked to complete a diary documenting the main PA they perform, how tired they feel, and how many hours they sleep each day. With these data, we will analyze the time spent performing moderate PA, time spent on sedentary activities, number of steps walked, and calories burned per day [ 39 ]. Health Economics An economic evaluation will be performed in parallel with the trial to assess the health benefits, additional costs, and potential savings of including exercise therapy as a standard of care for patients with cancer. This health economics analysis will provide the relative value for money of exercise medicine compared with other health care interventions in this patient population, stratified by age, cancer type, point along the cancer continuum, and stage of the disease. Hospital resource usage and associated costs will also be assessed to compare the costs of secondary health care utilization between the intervention and reference (usual care+PVS) groups. All hospital events, including emergency department attendances and admissions, outpatient visits and procedures, and inpatient admissions for all causes will be explored to quantify and identify potential disease-related events, as well as the total health care resource use for all other purposes inclusive of comorbidities and other chronic diseases. The cost of providing the supervised exercise and PVS interventions will also be quantified. Health benefits will be measured in terms of the quality of life based on the SF-6D utility index derived from the SF-36 and converted to a health utility score to obtain quality-adjusted life years for cost-utility analysis [ 40 ]. Adverse Events An external committee will review and compare all nonserious adverse events, whereas researchers will be obliged to report any serious adverse events to the research unit by email. A coordination committee with access to all the information it needs will undertake preliminary analyses of the data to monitor the safety of the program. This committee will be composed of individuals who are independent of the organization responsible for managing the study and members of the research team including the study coordinator; all are blind to patient allocation. In addition to serving on the committee, the coordinator will telephone the participating health centers daily to check on the progress of the study, report weekly on this progress to the principal investigator of the study, produce a monthly report with the study data, and provide recommendations to the study management team. The trial was registered on January 18, 2019 (Clinical NCT03819595).The protocol has been approved by the local Clinical Research Ethics Committee (CEIC de Euskadi, PI2019016). Effectiveness: Additional Measures Qualitative Evaluation Knowledge generated by qualitative evaluation is essential for designing a tailored implementation strategy to address organizational and professional barriers that may hinder the adoption of the Bizi Orain program under routine conditions. The qualitative evaluation is designed around the use of focus groups to explore the perceptions of each population involved in the study: clinicians (oncology and hematology services), exercise instructors, community agents (local authorities, managers, and instructors of fitness centers), and patients. Briefly, 14 focus groups with 5-8 members each will be conducted to acquire a global and heterogeneous perspective of the Bizi Orain program: 1 for clinicians, 1 for exercise instructors, 6 for community agents (1 per exercise laboratory), and 6 for patients (1 per exercise laboratory). The moderation of the discussions is structured based on the Consolidated Framework for Implementation Research (CFIR) [ 41 ] and adapted to each population. This theoretical framework is a valuable instrument to detect and analyze barriers and facilitators. This framework differentiates 39 constructs, organized into 5 domains or dimensions, which influence the degree of the real implementation of a program or intervention. Specifically, the 5 domains of the CFIR are the following: “characteristics of the intervention,” “external context,” “internal context,” “characteristics of the individuals involved,” and “implementation process.” Owing to the need for intervention on contextual factors—a key element in the design of any implementation strategy—and promotion of cooperation between health organizations and the community, the CFIR adapts to the analytical needs of this evaluation. In addition, the research team will adopt an inductive perspective to favor the emergence of concepts and issues not covered by this theoretical framework, which are key to understanding the mechanisms of Bizi Orain. The discourse generated in each group will be audio-recorded and transcribed verbatim. Moreover, the moderator and observer will prepare notes during the fieldwork to complete and triangulate the recorded data. Qualitative data analysis will be structured into three stages. First, a deductive analysis will be conducted to identify the constructs of the theoretical framework that influence the implementation of the Bizi Orain program. Second, an inductive analysis based on grounded theory [ 42 ] will be conducted to identify other emergent categories that have an impact on the program. Finally, a qualitative comparative analysis will be performed to identify the necessary and sufficient variables needed to improve the implementation of the Bizi Orain program in primary care exercise laboratories. Atlas Ti software (version 5.0, ATLAS.ti Scientific Software Development GmbH) will be used to analyze the qualitative data. Exercise Intervention The program operates throughout the year and is a free 12-week, small-group (~8 people) exercise program supervised by specially trained instructors. Participants are required to participate in supervised exercise twice a week and to exercise independently a third time, walking in the neighborhood of the health center at a given target exercise intensity. Carers of eligible participants are invited to attend the program with the care recipients. Individual Consultations Before commencing the program, each participant receives a one-on-one consultation with an exercise physiologist at Deusto University. This consultation involves screening of the health status and initial assessments to tailor the exercise prescription according to the type of cancer, stage and treatment history, severity of symptoms/adverse effects, comorbidities, PA habits, and personal preferences. Each participant’s exercise program is designed to provide optimal stimulus to the cardiorespiratory and neuromuscular systems while maximizing safety, compliance, and retention. Subsequently, patients return for further consultations to undergo assessments and assess their progress since initiating the program, discuss strategies to continue exercising after the program, and develop a plan to maintain long-term positive exercise behavior. Group Exercise Sessions Exercise sessions twice a week are conducted in groups of approximately 8 participants under the supervision of an accredited exercise physiologist or a nurse in the Bizi Orain exercise laboratories at the local health centers. The sessions last approximately 1-1¼ h and include a combination of moderate-to-high intensity aerobic and resistance exercises. The aerobic exercise component includes 30-35 min of at least moderate-intensity cardiovascular exercise using cycle ergometers and treadmills. The exercise intensity increases from moderate intensity for 8-min periods alternating with 2-min lower-intensity periods during the first month, moving toward higher-intensity 5-min intervals by the third month ( Figure 2 ). The exercise intensity zones are tailored to each patient by the estimated maximum heart rate using the equation 206.9 – (0.67 × age) [ 43 ] and applying specific intensity boundaries based on the HRR, defined as the difference between the resting heart rate and maximum heart rate. The %HRR has been adopted by the American College of Sports Medicine as the gold standard for indirect assessment of exercise intensity [ 44 ]. Every exercise session will be monitored with a heart rate monitor, teaching the patients to self-manage their exercise sessions with respect to the prescribed target intensities. The target intensity is between 40% and 85% of the HRR [ 44 ]. The perceived level of effort is recorded using the Borg RPE scale from 0 (rest) to 10 (maximal effort) [ 45 ], with the target intensity progressively increasing from 3 to 5-6 points ( Table 1 ). Table 1. Definitions of exercise intensity categories. Zonea

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