Zhang, Q., Li, F., Zhang, H., Yu, X., & Cong, Y. (2018). Effects of nurse-led home-based exercise & cognitive behavioral therapy on reducing cancer-related fatigue in patients with ovarian cancer during and after chemotherapy: A randomized controlled trial. International Journal of Nursing Studies, 78, 52-60.

Variable and key concepts

• The Objective of this study was to investigate the feasibility of a nurse-led home-based exercise and cognitive behavioral therapy (E & CBT) for ovarian cancer adults with cancer-related fatigue on outcomes of fatigue, plus other secondary outcomes  such as sleep disturbance and depression; either during or after completion of primary cancer treatment.
• The setting for this study was Gynaecologic oncology department of the First Hospital of Jilin University in China.
• However, the hypothesis was not stated. The implied hypothesis was that a nurse-delivered home-based exercise and cognitive behavioral therapy can be beneficial for the management of cancer-related fatigue, depressive symptoms, and improved quality of sleep. 
• Besides, the researchers aimed at answering the question about the feasibility of a nurse-led home-based E & CBT for adults with ovarian cancer and to study the effects on both primary (CRF) and secondary outcomes (sleep disturbance and depression). However, this research question was not clearly stated.
• The independent variables include T1 (before second chemotherapy treatment),
• T2 (immediately after a 12-week intervention but before the sixth chemotherapy treatment) and T3 (3 months after the end of the sixth chemotherapy treatment). Sub-independent variables included subjective sleep quality, sleep latency, sleep duration, sleep efficiency, and sleep dysfunction, use of sleeping medications and daytime dysfunction. The dependent variable was CRF.

Sampling

• The participants included 72 eligible women who recently had surgery and completed their first cycle of adjuvant chemotherapy. 
• The participants were randomly selected and assigned to two groups. That is, the experimental group received exercise and cognitive behavioral therapy. 
• The samples size of 72 was enough to provide sufficient evidence concerning the effectiveness of the intervention to reduce CRF. 
• Moreover, there were 2 drop-outs and 1 loss to follow-up in the experimental group during the study. The reason for dropping out or loss of follow up was not given.

Design and Method

• The researcher used randomized, single-blind control trial research design.
• The research was quantitative as it used randomized controlled trial (RCT) research design. RCTs seek to measure and compare the outcomes after the participants receive the interventions. Since the outcomes were measured, this study was quantitative.

Instruments/Data Collection

• The data collected included baseline data, such as demographic, disease, and chemotherapy treatment, as well as the differences between experimental and comparison groups.
• The zung self-Rating depression scale (SDS) was used to evaluate depressive symptoms.
• The Pittsburgh sleep quality index (PSQI) questionnaire was used to evaluate quality of sleep.
• The instruments were valid because the Cronbach’s α was 0.81–0.85. 

Results

• The results showed that for baseline comparisons, no significant differences were found between the two groups. After the interventions, the experimental group had lower behavioral fatigue subscale scores, sensory fatigue subscale scores, and cognitive fatigue subscale scores at T2 and T3 compared with the comparison group. However, no significant change in affective subscales was found between the two groups at three time-point comparisons. The comparison group showed almost no change in total fatigue score over time.
• Further, after the interventions, the experimental group participants demonstrated significantly lower symptoms of depression compared with the comparison group. The comparison group indicated almost no change in depression score over time.
• These results were expected and it makes sense because as the participants engage in the intervention, it is expected that the levels of fatigue will reduce over time and remain the same when no intervention is applied.

Strengths & Limitations

Strengths:

• The major strengths of this trial were the well-balanced socio-demographic and medical variables at baseline in both groups.
• Statistical significance was represented as p-values (two-sided) less than 0.05.
• The comparison group showed almost no change in total fatigue score over time. The repeated measures ANOVA, indicated that the differences of behavioral fatigue score  and cognitive fatigue score were statistically significant for the group by time interaction.

Limitations:

• Only outcome changes in two time points during the nearly 6-month intervention were investigated.
• Excluding the elderly patients who did not have the ability to exercise independently impaired the ability to generalize the results to the entire ovarian cancer population. 
• Further, the questionnaires were self-reported, and self-reported data is considered less accurate than objective data.

Critique

• Overall, this trial can be used to deliver exercise program coordinated with CBT to assist women with ovarian cancer to attain a clinically meaningful decrease in cancer-related fatigue, depressive symptoms, and improved quality of sleep. Based on the study findings, this study can be used for a literature review.
• The researchers did an excellent job in explicitly explaining the research to make it easy to comprehend. The research findings also make sense and can be used as evidence to advance clinical practice.

Ulrich, C. M., Himbert, C., Boucher, K., Wetter, D. W., Hess, R., Kim, J., & Marcus, R. (2018). Precision-Exercise-Prescription in patients with lung cancer undergoing surgery: rationale and design of the PEP study trial. BMJ open, 8(12).

Variable and key concepts

This Precision-Exercise-Prescription (PEP) study is a randomized phase III clinical trial that aimed at investigating the effect of a personalized exercise program on physical function, as measured by the 6 min walk (6 MW) test, in patients with NSCLC (Stage I, II, III) and patients with secondary lung cancer who are undergoing surgical treatment at the Huntsman Cancer Institute (HCI).

The independent variables include quality of life (QoL), fatigue, pain, sleep and self-efficacy), clinical outcomes (length of stay, complications, readmission and pulmonary function) and treatment-related cost.

The depended variables included individually prescribed exercise modes (mobility, flexibility, callisthenic, aerobic and resistance) and dosages (low, moderate, high) tailored to the patient’s AM-PAC mobility stage. The researchers hypothesized that patients with lung cancer undergoing surgical resection will improve their physical function by participating in a PEP tailored to their mobility level, motivation, and other behavioral and environment factors as they progress (or regress) through the multiple phases of the pre-surgery and post-surgery periods. 

The research question was not clearly stated. However, the researchers aimed at answering the question about the clinical effectiveness and feasibility a personalized exercise intervention in patients with lung cancer undergoing surgery.

Sampling

This study used a sample size of 200 patients with NSCLC stage I, II or IIIa, or secondary lung cancer over 18 years old, who undergo surgical lung resection at HCI. The researchers used enough sample size to enable the findings to be generalized. 

However, of the 200 participants, 25 percent are expected to drop out without any reason.

Design and Method

The researchers employed single-center, prospective, two-armed, phase III randomized controlled trial at HCI in Salt Lake City, Utah. Because the researchers used RCT, the study is quantitative considering RTC are intended to measure outcomes.

Instruments/Data Collection

The researchers collected data concerning gender, age, baseline smoking status, primary or secondary lung cancer, neo-adjuvant treatment, tumor stage, baseline level of outcome, pain, and sleep. The data was sufficient to determine the clinical effectiveness and feasibility of a personalized exercise intervention in patients with lung cancer undergoing surgery.

The researchers used the Activity Measure for Post-Acute-Care outpatient basic mobility (AM-PAC) measurement tool which is a well-validated and highly standardized instrument. 

Results

This is an ongoing trial and the primary results from the PEP study will test the clinical effectiveness and feasibility of a personalized exercise intervention in patients with lung cancer undergoing surgery. 

This trial makes sense because it fills the gap in knowledge precisely, by testing an exercise intervention that can be readily integrated into the clinic and by obtaining data on functional efficacy and PROs.

Strengths & Limitations

Strengths:

• This is the first randomized controlled trial to examine a personalized exercise program for both, patients with primary and secondary lung cancer. 
• The intervention is designed to be aligned with and easily translatable into the clinical workflow and spans the entire continuum of care from the pre-surgery to post-surgery period including lung cancer survivorship.
• The results will yield important healthcare cost information using the value-driven outcomes tool.

Limitations:

The biggest limitation of this study is that the cost of the behavioral intervention delivered by a physical therapist for weekly phone calls during the outpatient period may still be too high for future implementation in healthcare settings.

Critique

Overall, this PEP study will be the first study to test the clinical effectiveness and feasibility of a personalized exercise intervention in patients with lung cancer undergoing surgery. This study provides valuable information concerning a personalized intervention to reduce CRF, thus, can be used in the literature review. After following through the pilot study, this study seems easy to understand and makes sense because the authors have heighted the procedures of how the study will be conducted and how the variables of concerned will be measured.

Berntsen, S., Aaronson, N. K., Buffart, L., Börjeson, S., Demmelmaier, I., Hellbom, M., ... & Raastad, T. (2017). Design of a randomized controlled trial of physical training and cancer (Phys-Can)–the impact of exercise intensity on cancer related fatigue, quality of life and disease outcome. BMC cancer, 17(1), 218.

Variable and key concepts

This study aimed at conducting a Phys-Can project that implemented an endurance exercise to determine the effects of low-to-moderate and high intensity physical exercise with or without BCTs on CRF and HRQoL in persons with cancer, both during treatment and in the long-term, post-treatment survivorship period. The primary (outcomes independent variables) in this study included fatigue and health related quality of life, which are measured by self-reports. Secondary outcomes (independent variables) include fitness, mood disturbance, and adherence to the cancer treatment, adverse effects, and return to activities of daily living after completed treatment, return to work as well as inflammatory markers, cytokines, and gene expression. The dependent variable was the Cancer-related fatigue (CRF). 

Sampling

The researchers used a sample size of 600 newly diagnosed persons with breast, colorectal or prostate cancer undergoing adjuvant therapy. The sample size was large enough to be generalized to the targeted population.\

the participants were  randomized in a 2 × 2 factorial design to following conditions individually tailored

low-to-moderate intensity exercise with or without behavior change techniques; or individually tailored high

Intensity exercise with or without behavior change techniques. The dropout rate was at 30 percent without any reason.

Design and Method

The researchers used a randomized controlled trial research design with a preceding descriptive observational study used for comparisons.  The RCT was stratified and within each stratum randomization was carried out following a permuted block design with 8 participants per block. The defined strata were the three hospitals (Linköping, Lund, and Uppsala) and three cancer sites yielding 9 strata.

Since this study employed RCT research design, it is quantitative because the RTC measured outcomes.

Instruments/Data Collection

A web-portal was designed to facilitate collection of outcome measures in the multiple study sites and to enable easily accessible electronic self-monitoring of exercise behavior. The data collected on mood was assessed by Hospital Anxiety and Depressions scale HADS. Data collected on functioning in daily life was assessed by the World Health Organization Disability Assessment Schedule WHODAS II. Data collected on readiness to change physical activity behavior  was measured by the Exercise Stage Assessment Instrument (ESAI), Exercise Barrier Self-Efficacy Scale (ESES); progressive goal attainment and perceived behavioral control are used to assess cognitive-behavioral moderators and mediators data. Cardiorespiratory fitness data collected was measured as maximal oxygen uptake during maximal walking/running until exhaustion on a treadmill using a modified Balk protocol. These instruments are valid as they are standardized tools. 

Results

The results suggest that  the Phys-can study will contribute to the understanding of the value of exercise and exercise intensity in preventing CRF and maintaining HRQOL during and after treatment and, potentially, clinical outcomes as well. The results also implied that BCT do not have to target the exercise behavior during supervised sessions; rather, the support should target behaviors pertaining to unsupervised or home-based exercise. These results are expected and make sense because they also offer insights into possible biological mechanisms through which exercise influence treatment outcomes.

Strengths & Limitations

Strengths:

• All the physical fitness tests, physical activity monitoring, and conducting exercise of low-to moderate or high intensity, seem feasible to implement in exercise oncology interventions. 
• Strength is that the exercise including resistance training with arm movements above the head and repetitive muscle contractions of the arm is feasible and may be safe for patients wearing a peripherally inserted central venous catheter because of the adjuvant chemotherapy.
• A 5% significance level was adjusted using Bonferroni correction. Statistical significance was supported by the 80% power to detect a main factorial effect of 2 under the null hypothesis of no effect.

Limitations:

The greatest limitation was that the sample size was calculated to be 600 persons in total, which proved to be a challenge in a multicenter, complex intervention study as the current study.

There are also there are significant challenges associated with a change of lifestyle during and following cancer treatment.

Critique

Overall, this study showed that the value of BCTs in terms of adherence to, and maintenances in, exercise behavior in persons with cancer will be evaluated. Therefore, it is understandable that the implementation of the findings of this study into clinical practice need to be facilitated by the close collaboration between researchers and clinicians including the facts that the study is performed in non-clinical setting to establish a pathway between hospitals to society. This study is easy to understand and makes sense because the researcher took their time to explain the results in simple terms that make sense to anyone without clinical knowledge.