Health & Medical Cancer & Oncology

Too Sick Not to Exercise

Too Sick Not to Exercise

Methods


This article reports on phase 1 of a 2-phase study. Following the Transitional Care Model, phase 1 of the study was designed to leverage the strengths of our transdisciplinary team to ensure continuity of care to address the critical transition from hospital to home and initiate exercise for 6 weeks through the transition to maintenance of exercise including the critical transition through initiation of chemotherapy and/or radiation therapy as applicable. Upon completion of phase 1, participants were asked if they would like to participate in phase 2 of the study. Phase 2 addressed the maintenance of exercise for an additional 10 weeks including continuance through completion of chemotherapy and/or radiation therapy as applicable.

Sample and Setting


The target sample was derived from 2 participating sites at a university-affiliated teaching hospital within the western Michigan area. A single-arm feasibility study was implemented in late November 2010 after achieving full-board approval from institutional review boards at 2 universities and the recruitment site. With the exception of the recruitment of 1 participant, the initial eligibility criteria and study protocol were found to be too stringent and not feasible (Figure 1). These criteria and protocol were later revised after our transdisciplinary team reviewed the initial screening data and the data of the 1 participant who enrolled and completed the intervention. The refined eligibility criteria and protocol were initiated in May 2011 after obtaining a second set of full-board approvals and resulted in 5 participants being recruited in the first 3 weeks (Figure 2). We met the minimum enrollment objective (n = 5–10) by enrolling 7 participants, which provided diversity for the feasibility sample. Major eligibility criteria are outlined in Table 1 . Upon completion of the 6-week intervention (phase 1), participants were given the option to extend their study participation for an additional 10 weeks (phase 2). All 7 participants elected to extend participation for an additional 10 weeks.



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Figure 1.



n Study flow initial inclusion and exclusion criteria. *Eligibility criteria were modified for second screening as follows: removed exclusion of those with greater than stage II non-small cell lung cancer (NSCLC) for the second screening; removed exclusion of those with a previous history of cancer for the second screening; removed exclusion of those who had nonlobectomy procedures for the second screening; obese was modified from excluding those with a body mass index of 30 kg/m or greater to exclude those weighing more than 300 lb; removed the requirement of having an exercise spotter present at all times for the second screening.







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Figure 2.



Study flow post–adjusted inclusion and exclusion criteria.




Presurgery Procedures


A clinical oncology research nurse screened, identified, recruited, and enrolled patients who were expected to undergo surgery for suspected lung cancer. Potential participants were identified during clinic appointments while undergoing diagnostics to confirm a potential diagnosis of NSCLC. Written informed consent was obtained from all participants before initiating any study procedures, followed by collection of presurgery baseline data by trained research staff. Following principles of the Transitional Care Model, a primary registered nurse intervener (nurse) was assigned to each participant for the duration of the study to ensure joint healthcare team–patient collaboration and continuity of care. A preassigned secondary nurse was designated should the primary nurse become ill or unable to meet with the participant. The nurse engaged each participant after presurgery baseline data were collected and provided an overview of the exercise intervention while teaching PSE-enhancing CRF self-management education (prepared participant to self-manage CRF and participate in exercise after discharge from the hospital). The PSE-enhancing CRF self-management education was provided to each participant in the participant's CRF resource book to be used by the participant throughout the study and included information based on the National Comprehensive Cancer Network Practice Guidelines for Cancer-Related Fatigue.

Postsurgery Procedures


Home Screen. The nurse conducted a telephone visit within 3 days after hospital discharge to screen for readiness to start the exercise intervention. To ensure safe exercise participation, participants were deemed ready to start if their usual level of symptom severity in the last 24 hours for key symptoms of pain, nausea, vomiting, and dyspnea was rated less than or equal to 5 on an 11-point scale (0–10, 10 = most severe). If the participant was ready to exercise, the nurse scheduled a home visit to start the exercise intervention within a week of hospital discharge. When a key symptom severity was rated greater than 5, the nurse contacted the participant's surgeon's office for recommendations. The nurse would repeat this step each day until the participant was ready to start exercising.

First Home Visit. The first home visit included setting up the exercise equipment—the Nintendo Wii Fit Plus—to the participant's television, teaching the exercise intervention, and reinforcing the CRF self-management education and exercise safety precautions. The nurse followed up the home visit with a phone visit within 24 hours to answer any questions and concerns regarding the exercise intervention.

Follow-up Visits. The nurse scheduled a home visit at the start of week 2 of the exercise intervention and phone visits at the start of weeks 3 to 6 with additional visits available on request of the participant. During these visits, the nurse reviewed the participant's Daily Diary with the participant and provided PSE-enhancing CRF self-management interventions to support the exercise intervention and adjust the exercise prescription per guidelines. The participant used the Daily Diary to record exercise-related activity and symptoms or problems.

Intervention


The 6-week exercise intervention designed to enhance PSE for CRF self-management to augment the rehabilitation of postsurgical NSCLC patients was initiated on the first home visit. The intervention was designed to promote regular, light-intensity walking and balance exercise of less than 3.0 metabolic equivalents that corresponds to levels of usual activities of daily living. Combining walking with balance exercises has been found to have a positive effect on balance, confidence in walking, and walking speed. Participants also performed warm-up exercises designed for this patient population. Walking with the Wii throughout this article implies walking in place with the Wii. Walking with the Wii was comfortable and self-paced (eg, participants could stop instantly—unlike a treadmill). The Wii Fit Plus provided a virtual environment where the participant saw themselves, friends, and even their dog walking on a sunny day next to a stream, through a village with happy, familiar faces offering encouragement. As they walked in place in their home, they saw themselves taking a corresponding step in the virtual environment. Duration of walking started at 5 minutes each day for 5 days during week 1 and was anticipated to increase by 5 min/d each week with the goal of walking 30 min/d during week 6. At the start of each week, the nurse assessed the participant's readiness to advance the walking prescription. The duration was increased 5 minutes each week if the participant's PSE for attaining that duration was greater than 70% on a 0% to 100% scale, with 100% having high PSE. Gradually increasing walking duration promotes achievement of exercise goals building PSE for CRF self-management and walking. Participants performed Wii Fit Plus balance exercises 5 days a week for weeks 1 to 6 selecting from a menu of predetermined Wii balance exercises. Balance exercises used a gaming format and scoring system as motivation to improve performance and included downhill skiing, soccer, golf, and video game activities. Exercises used competitive and engaging formats, keeping users captivated while they were exercising. Exercises provided encouragement that participants could partake in hobbies they may have thought they could never participate in again. Participants wore a pedometer to record their total number of steps per day. Data were recorded in the participant's Daily Diary.

Intervention Safety. Inclusion criteria required that participants have phone access while exercising should the participant need assistance. Participants were provided safety criteria prior to the start of each exercise intervention. Participants were taught to maintain a light-intensity dose of exercise by (1) monitoring their heart rate using a heart rate wristwatch to ensure their heart rate was less than or equal to 60% of their heart rate reserve, (2) ensuring their perceived level of exertion was less than 3 on a scale of 0 to 10, and (3) ensuring they could talk and sing while exercising (Talk Test). Participants documented any symptoms/problems that occurred during the exercise intervention and any action taken in response in their Daily Diary for review by the nurse. The nurse was available by phone and could make a home visit to ensure the safety of the participant. Should participants report unmanaged symptoms (>5 on a scale of 0–10, 10 = most severe) or clinical problems, participants were referred to their healthcare provider, and these referrals were recorded in the nurse intervener log. The nurse intervener log provides a study protocol for weekly participant telephone or home visits and a log to include any participant-reported unmanaged symptoms or clinical problems for which they were referred to their doctor.

Descriptive Variables and Study End Points


Physiological and contextual patient characteristics depict the sample. Physiological patient characteristics included age, race, gender, performance status, comorbid conditions, smoking status, surgical procedure, cancer stage, histological type, length of hospital stay, body mass index (BMI), and adjuvant treatment. Contextual patient characteristics included education level, employment status, marital status, number of children living at home, and income level. Physiological and contextual patient characteristics were collected via demographic questionnaire, medical record chart review, and a modified Comorbidity Questionnaire. Comorbid conditions were assessed using a modified version of the Comorbidity Questionnaire, which was used to inquire about the presence of 15 chronic health conditions, with content validity and test-retest reliability having been established. For this study, this variable consisted of the sum of the total number of chronic health conditions identified via the Comorbidity Questionnaire combined with the patient report of other comorbid conditions as confirmed in the medical record. Smoking status (never, former, current) was determined through responses to questions based on the Behavioral Risk Factor Survey regarding tobacco history and current smoking status. The Karnofsky Performance Status (KPS) was used as an objective appraisal of physical functioning and a psychometrically sound proxy for health status and quality of life. The KPS is commonly used in oncology and is scored from 0%, meaning dead, to 100%, meaning no complaints, no special care needs with no evidence of disease. A score of 50% indicates a person needs considerable assistance and frequent medical care. Feasibility was determined by analyzing rates of recruitment, adherence, retention, and monitoring for adverse events. An Acceptability Questionnaire was conducted at the end of week 6 (postintervention). Four questionnaires were used to measure change in study end points including the Brief Fatigue Inventory (BFI), Perceived Self-efficacy for Fatigue Self-management (PSEFSM) Instrument, the Self-efficacy for Walking Duration Instrument, and the Activities-Specific Balance Confidence Scale. The Daily Diary provided the participant with the means to record CRF self-management behaviors (walking and balance exercise) during the exercise intervention and functional performance (number of pedometer steps each day). Collection of end-point data excluding the Acceptability Questionnaire was performed by trained research staff in person for presurgery and via telephone for postsurgery prior to the start of the intervention and at the end of weeks 1 through 6, with corresponding Cronbach's [alpha]'s presented in Table 3 and Table 4 . The Acceptability Questionnaire was mailed to participants by research staff at the conclusion of the research study. Participants completed their questionnaire at their leisure in their home and mailed them back to research staff when completed.

Feasibility. Feasibility was determined by analyzing the recruitment rate, which was measured as the percentage of eligible patients who were recruited who consented. Adherence was measured as the percentage of those participating in the intervention that adhered to the intervention. Weekly adherence was calculated by taking the number of times the prescribed intervention was completed divided by the number of interventions prescribed for the week. Retention was measured as the percentage of those enrolled that completed the program from the first phone visit after surgery to the final data collection at week 6. Adverse events were to be recorded in the Daily Diary and monitored by the nurse and principal investigator. Likewise, any unmanaged symptoms or clinical problems requiring physician referral were recorded by the nurse in the nurse intervener log and monitored by the principal investigator. Our goal to show feasibility was to be able to recruit 50% of eligible participants and show adherence and retention to the intervention at a rate of 70% with minimal adverse effects. These goals were based on the NSCLC exercise study results from the work conducted by Jones et al and the home-based exercise study results from the study of Mock et al.

Acceptability Questionnaire. Acceptability assessment for this study was similar to those used in other exercise studies. The research team developed a questionnaire for the participants with a Flesch-Kincaid reading grade level of 6. Participants rated their degree of satisfaction with the exercise intervention for 15 items on a 6-point Likert scale from strongly disagree to strongly agree. An average positive acceptability score of 4 (1–6; 6 = agrees strongly) was set as the minimum level to achieve to indicate the intervention was acceptable.

The BFI is a 9-item measure of CRF severity and its impact on daily functioning. On an 11-point scale (0–10, 10 = most severe), 3 items measure fatigue severity (now, usual, and worst fatigue), and 6 items measure the impact of fatigue on daily functioning in the past 24 hours. Substantial evidence supports the psychometrics of the BFI in the cancer population, with Cronbach's [alpha] ranging from .82 to .97.

Perceived Self-efficacy for Fatigue Self-management Instrument contains 6 items measuring on an 11-point scale (0–10, 10 = very certain) confidence in performing fatigue self-management behaviors. Content and construct validity through mediation analyses and structural modeling demonstrated sound psychometrics in persons with cancer diagnoses, with a reported Cronbach's [alpha] of .92 for persons with cancer including lung cancer.

Perceived Self-efficacy for Walking Duration Instrument measures a person's confidence to complete incremental 5-minute periods of light-intensity pace walking (5–30 minutes) on an 11-point scale (0%–100%, 100% = highly confident). Internal consistency reliability reported for a sedentary, older sample with comorbid conditions including cancer for pre-exercise and postexercise was a Cronbach's [alpha] greater than .95.

Activities-Specific Balance Confidence Scale is a 16-item scale measuring confidence for balance during specific everyday physical activities. On an 11-point scale (0%–100%, 100% = most confident), higher scores indicate greater balance confidence during physical activities such as walking in and outside the home. The scale has demonstrated sound psychometrics tested in diverse populations of older adults living at home or in retirement communities with test-retest reliability over a 2-week period, high internal consistency with Cronbach's [alpha] ranging from .82 to .90, convergent and discriminant validity, and the ability to discriminate between fallers and nonfallers and low-versus high-mobility groups.

The Daily Diary is a weekly diary that provides the participant with a structured format using a tabular design for which they can enter their weekly exercise prescription (provided by the nurse during the weekly home or phone visit) as well as their daily exercise performance. The Daily Diary provides the participant a means to capture CRF self-management behaviors such as the daily number of minutes walked and number and type of balance exercises performed. The participant also records the number of steps taken each day in the Daily Diary as indicated by the Sportsline Step and Distance Pedometer. Except for riding a bike and swimming, pedometer readings have been found to be valid and reliable measures of functional performance. Participants wore the pedometer every day for 6 weeks of the study except during Nintendo Wii exercise so that nonintervention performance levels could be assessed.

Data Analysis


All analyses were conducted with IBM SPSS Statistics version 19.0. Descriptive statistics were calculated to estimate the frequencies, means, and SDs of the study variables. Next, the pattern of change in CRF severity; PSE for fatigue self-management, walking, and balance; CRF self-management walking and balance exercise behaviors; and the number of pedometer steps per day per week were longitudinally displayed. Results were depicted at baseline presurgery and postsurgery prior to the start of the intervention and at the end of each week of the 6-week intervention.

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