Feasibility and safety of the 30-second sit-to-stand test delivered via telehealth: An observational study.

INTRODUCTION: Exercise testing is essential to determine the safety and efficacy of prescribing exercise. Limited evidence exists to support remotely supervised exercise testing in oncology literature. OBJECTIVE: To determine the feasibility, safety, and convergent validity of the 30-second sit-to-stand test (30STS) delivered via telehealth in an oncology population. Exploratory analyses informed remote test feasibility according to participant and treatment characteristics. DESIGN: Cross-sectional, observational study. SETTING: Telehealth outpatient clinic, tertiary metropolitan oncology hospital. PARTICIPANTS: Thirty-two consecutive outpatients attending telehealth exercise appointments were screened for inclusion. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: A pre-test safety screening questionnaire included the Australia-modified Karnofsky Performance Status (AKPS) and Clinical Frailty Scale (CFS). Following one practice, one 30STS test was completed using a standardized protocol modified for telehealth assessment. Secondary measures: International Physical Activity Questionnaire-Short Form (IPAQ-SF) and pre/post-test Borg Rating of Perceived Exertion (RPE). RESULTS: Thirty participants were deemed as being safe using the screening questionnaire and completed the remote 30STS. Participants were a median (interquartile range [IQR]) 62.5 (51.8 to 66.5) years old, 59% male, 72% undergoing cancer treatment, 34% with metastatic disease, and 56% met current exercise guidelines. Moderate correlation was found between 30STS and IPAQ-SF (rho = 0.49, p = .006), providing evidence of convergent validity. Correlations between 30STS and AKPS (rho = 0.26, p = .161), and CFS (rho = -0.23, p = .214), were fair. Chair-height standardization was poor (range 43 to 60 cm). The clinician could visualize the participant's whole body in 2 of 30 tests. No significant difference in test performance was found for participants with metastatic disease, higher age, or body mass index. No adverse events occurred. CONCLUSION: With screening, the 30STS, performed by telehealth, is a safe and feasible measure of function and lower limb strength. Telehealth exercise testing presents challenges in standardizing the environment and ensuring participant safety. Minimal space and equipment requirements and moderate convergent validity with physical activity provide good clinical utility in this setting.

ENhAncing Lifestyle Behaviors in EndometriaL CancEr (ENABLE): A Pilot Randomized Controlled Trial.

PURPOSE: Endometrial cancer is associated with the highest comorbid disease burden of any cancer. The aim of this trial was to assess the feasibility and safety of an allied health intervention during adjuvant treatment. METHODS: A mixed-methods pilot randomized (2:1) controlled trial with concealed allocation and assessor-blinding. Eligibility criteria: adjuvant endometrial cancer treatment scheduled, disease stage I-IIIC1, ECOG 0-2 and able to perform unsupervised physical activity (PA). Participants received usual care and 8 sessions of weekly, individualized, lifestyle education (diet and PA) with behavior change and social support (intervention group), delivered predominantly by telehealth, or usual care alone. Feasibility outcomes: recruitment and consent rates, decline reasons, program acceptability, intervention adherence and retention. RESULTS: 22/44 eligible patients (50%, 95%CI: 36%, 64%) were recruited over 10 months (14 intervention, 8 usual care). The recruitment rate was 2.2 patients/month (95%CI: 1.4, 3.3). Patients who declined had too much going on (7/22, 32%) or were not interested (6/22, 27%). Mean (SD) age and BMI were 63.2 years (6.8) and 31.9 kg/m2 (6.7). A majority were FIGO stage I (15/22, 68%) and received vaginal brachytherapy (14/22, 64%). Adherence was high, 11/14 (79%, 95%CI: 52%, 92%) participants attended >70% of scheduled sessions. Retention was 100% (95%CI: 85%, 100%) at 9 weeks, however completion of objective measures was impacted by COVID-19 restrictions. Telehealth and online questionnaires enabled participation. No serious adverse events occurred. CONCLUSION: The intervention was acceptable to participants with high levels of adherence and retention. Trial findings will be used to design a future RCT. TRIAL REGISTRATION: The trial was registered on www.anzctr.org.au (ACTRN12619000631101) 29/04/2019.

i-Move, a personalised exercise intervention for patients with advanced melanoma receiving immunotherapy: a randomised feasibility trial protocol.

INTRODUCTION: There is increasing evidence demonstrating the benefits of exercise in counteracting cancer treatment-related fatigue. Immunotherapy is an established treatment for advanced melanoma, and is associated with fatigue in a third of patients. The safety and efficacy of exercise in counteracting treatment-related fatigue in patients with advanced melanoma receiving immunotherapy are yet to be determined. This study aims to assess the safety, adherence to and acceptability of a mixed-methods parallel-group, pilot randomised controlled trial of a personalised, 12-week semi-supervised exercise programme prescribed by an exercise physiologist (iMove) in 30 patients with stage IV melanoma scheduled to commence immunotherapy: single agent ipilimumab, nivolumab or pembrolizumab, or combination ipilimumab and nivolumab. The trial will be used to provide preliminary evidence of the potential efficacy of exercise for managing fatigue. METHODS AND ANALYSIS: Thirty participants will be recruited from a specialist cancer centre between May and September, 2019. Participants will be randomised 1:1 to receive iMove, or usual care (an information booklet about exercise for people with cancer). Feasibility data comprise: eligibility; recruitment and retention rates; adherence to and acceptability of exercise consultations, personalised exercise programme and study measures; and exercise-related adverse events. Patient-reported outcome measures assess potential impact of the exercise intervention on: fatigue, role functioning, symptoms and quality of life. Follow-up will comprise five time points over 24 weeks. Physical assessments measure physical fitness and functioning. ETHICS AND DISSEMINATION: This study was reviewed and approved by the Peter MacCallum Cancer Centre Human Research Ethics Committee (HREC/48927/PMCC-2019). The findings from this trial will be disseminated via conference presentations and publications in peer-reviewed journals, and by engagement with clinicians, media, government and consumers. In particular, we will promote the outcomes of this work among the oncology community should this pilot indicate benefit for patients. TRIAL REGISTRATION NUMBER: ACTRN12619000952145; Pre-results.