Capability, Opportunity, and Motivation-Identifying Constructs for Increasing Physical Activity Behaviours in Women with Polycystic Ovary Syndrome (PCOS).

Polycystic ovary syndrome (PCOS) is the commonest endocrinopathy in reproductive-aged women. Because increased adiposity is pivotal in the severity of PCOS-related symptoms, treatment usually incorporates increasing energy expenditure through physical activity (PA). This study aimed to understand the reasons why women with PCOS engage in PA/exercise, which could support the development of targeted behavioural interventions in this at-risk population. Validated questionnaires were administered for self-reported PA levels, quality of life, mental health, illness perception, sleep quality, and capability, opportunity, and motivation (COM) for PA. Using categorical PA data, outcomes were compared between groups; ordinal logistic regression (OLR) was used to identify whether COM could explain PA categorisation. A total of 333 participants were eligible; favourable differences were reported for body mass index, depression, mental wellbeing, self-rated health, illness perception, and insomnia severity for those reporting the highest PA levels. COM scores increased according to PA categorisation, whilst OLR identified conscious and automatic motivation as explaining the largest PA variance. The most active participants reported favourable data for most outcomes. However, determining whether health is protected by higher PA or ill health is a barrier to PA was not possible. These findings suggest that future behavioural interventions should be targeted at increasing patient motivation.

The Association between Dietary Inflammatory Index with Risk of Coronavirus Infection and Severity: A Case-Control Study.

Background: Recently, several have evaluated the association between the components of the dietary inflammatory index (DII) score with the risk and severity of Coronavirus Disease 2019 (COVID-19). For the first time, we examined the association between DII® with risk of coronavirus infection and symptom severity through a case-control study in Iran. Methods: The present case-control study was conducted on COVID-19 cases (n = 100) and healthy control (n = 100) volunteer, aged from 18 to 65 years. Dietary intake, DII, body mass index, COVID-19 infection, and the severity of its symptoms were assessed for each participant. A multivariable logistic regression analysis test was used to estimate the odds ratio and 95% confidence interval. Results: Our results demonstrated that COVID-19-infected patients were significantly older and had longer history of diabetes as compared to the healthy control group (P <.05). Furthermore, the participants with COVID-19 had a significantly greater intake of total fat (P =0.259), saturated fat (P =0.005), and dietary fiber (P = .004). In contrast, individuals in the healthy control group had a higher intake of carbohydrate (P = .005), sodium (P <.001), and iron (P <.001). However, there was no significant difference in DII score between COVID-19 and healthy controls (P =.259). In addition, we did not detect any specific association between DII score and risk of COVID-19 infection (odds ratio = 1.08, 95% confidence interval: 0.92 to 1.27; P =.294) and the severity of its symptoms (P >.05). Conclusions: There appears to be no specific association between DII score and risk of COVID-19 infection and the severity of its symptoms. More prospective cohort studies are necessary to confirm the veracity of our results.

The effects of adjunctive treatment with L-carnitine on monitoring laboratory variables in ICU patients: a double-blinded randomized controlled clinical trial.

BACKGROUND: Critically ill patients must be monitored constantly in intensive care units (ICUs). Among many laboratory variables, nutritional status indicators are a key role in the prognosis of diseases. We investigated the effects of L-carnitine adjunctive therapy on monitoring variables in critical illness. METHOD: A prospective, double-blind, randomized controlled trial was implemented in a medical ICU. Participants were 54 patients, aged > 18 years, with multiple conditions, randomly assigned to receive 3 g L-carnitine per day or placebo, along with enteral feeding, for 1 week. Primary outcomes included monitoring variables related to nutritional status. RESULT: Of 54 patients randomly assigned, 51 completed the trial. Serum albumin (Alb) (P-value: 0.001), total protein (P-value: 0.003), and calcium (Ca) (0.044) significantly increased in the intervention vs. control group. Alanine transaminase (ALT) (0.022), lactate (<0.001), creatinine (Cr) (0.005), and international normalized ratio (INR) (0.049) decreased meaningfully in the intervention vs. control group. CONCLUSION: L-Carnitine supplementation in critically ill patients can improve several parameters including INR, Cr, ALT, lactate, Ca, Alb, and total protein. TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT 20151108024938N2. This trial was approved by the Research Ethics Committee of Mashhad University of Medical Sciences (registration code: IR.MUMS.fm.REC.1396.671) (available at https://en.irct.ir/trial/30748 , May 2018).

Eight Weeks of Pilates Training Improves Respiratory Measures in People With a History of COVID-19: A Preliminary Study.

BACKGROUND: Coronavirus disease 2019 (COVID-19) can result in prolonged and severe damage to the lungs and quality of life (QoL). This study was designed to investigate the effects of 8-week Pilates and Aqua-Pilates training on pulmonary function and QoL in patients with COVID-19. HYPOTHESIS: Pilates and Aqua-Pilates training promotes similar changes on pulmonary function and QoL in people with a history of COVID-19. STUDY DESIGN: Randomized controlled trial. LEVEL OF EVIDENCE: Level 3. METHODS: A total of 45 participants (24 men and 21 women) with a history of COVID-19 were assigned randomly to 3 groups: Pilates training (standard Pilates), Aqua-Pilates training (Pilates in water), and Control. The training protocol was performed for 8 weeks (3 sessions per week). Forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), and the ratio of FEV1 to the FVC (FEV1/FVC) indices were measured by a spirometer. The 26-item questionnaire World Health Organization Quality of Life (WHOQOL) BREF was used to assess QoL. Data were analyzed using paired-sample t test and analysis of covariance with an alpha level <0.05. RESULTS: The mean age of the participants was 49.9 ± 6.4 years. After 8 weeks of Pilates and Aqua-Pilates training, there were significant increases in FVC (21.4% for Pilates and 22.1% for Aqua-Pilates, P < 0.05), FEV1 (32.3% for Pilates and 34.7% for Aqua-Pilates, P < 0.05), and FEV1/FVC% (9% for Pilates and 10.3% for Aqua-Pilates, P < 0.05) for the experimental groups, but not for control. Changes for Pilates and Acqua-Pilates were significantly higher than for control. The QoL scores were significantly different within and between the experimental groups, with greater improvements in the Aqua Pilates group than in the Pilates group. CONCLUSION: An 8-week Pilates or Aqua-Pilates training can improve pulmonary function as much as 34%, depending on the parameter, and QoL in people with a history of COVID-19. Aqua-Pilates training appears to be preferable to standard Pilates. CLINICAL RELEVANCE: The findings provide important insights into how healthcare professionals can prescribe exercise for COVID-19 survivors.

High social vulnerability affects survival of pediatric patients with abusive head trauma: Comparison during COVID-19

Background: Abusive Head Trauma (AHT) is a syndrome of life-threatening intracranial injuries. The COVID-19 pandemic imposed new stresses upon socially vulnerable populations, but the relationships between social vulnerability, COVID-19 and AHT outcomes are not known. We investigated whether patient or social factors predicted survival after AHT and whether these factors and outcomes were modified during COVID-19. Methods: A single-institution database was queried for all admissions of children with a confirmed diagnosis of AHT from 2018-2021. Clinical information, radiographs and clinic follow-up data were reviewed. Social vulnerability index (SVI) was calculated based on published methods (atsdr.cdc.gov). Univariate and multivariate analyses were performed. Results: One hundred and three cases of AHT were reviewed. Median age at presentation was 4 months (IQR 2-10) in the overall cohort, males outnumbered females overall (76 males, 27 females). 18 patients died (17.5%), higher than previously reported rates. Nonsurvivors had higher social vulnerability index (.867 vs .719, p=0.004);71% had high social vulnerability compared to 39% of survivors. There was no difference in fatality rate before (19%) or during (15%) COVID-19. All nonsurvivors were intubated on admission, compared to 36% of survivors (p<0.001) and all nonsurvivors were comatose compared to 29% of survivors (p<0.001);61% of nonsurvivors had cardiac arrest on admission compared to 3% of survivors (p<0.001). The injury severity score of nonsurvivors was higher than that of survivors (27 vs 17, p=0.02 in univariate analysis). Nonsurvivors were less likely to have multiple fractures (11% vs. 43%, p=0.01). Nonsurvivors were more likely to have bilateral hypoxic ischemic injury (HII, 89% vs 29%, p< 0.001, Crude OR for survival 0.33, p<0.001, p=0.017 in multivariate analysis). There was no difference in rates or types of neurosurgical intervention, intracranial hemorrhage location, or presence of spinal hemorrhage between nonsurvivors and survivors. Discussion: Mortality from AHT in our series was higher than previously reported: more than one out of six children in our series did not survive. Although nonsurvivors were more likely to live in highly vulnerable social settings, COVID-19 did not change survival rate. Nonsurvivors are more likely to present in coma requiring intubation and in cardiac arrest. Subdural hematomas are seen in survivors and non-survivors but surgical mass lesions are rare and surgery does not improve survival. We identify a strong association between completed bilateral HII on admission and fatality in AHT. The high mortality of AHT in association with HII, and the low efficacy of intervention after completed HII supports a public health effort towards treatment and prevention focusing on socially vulnerable communities.

A Digital Self-management Program (Help to Overcome Problems Effectively) for People Living With Cancer: Feasibility Randomized Controlled Trial.

BACKGROUND: We present the results of a feasibility, randomized waitlist control group (CG) parallel design study with a 1:1 allocation ratio. Participants were randomized into an intervention group (IG) or a waitlist CG. The intervention was a 6-week digital self-management program, Help to Overcome Problems Effectively (HOPE), for people with cancer. OBJECTIVE: This study aims to test the feasibility of a digitally delivered self-management program for people with cancer. This will inform the design of a definitive randomized controlled trial. In addition, a preliminary assessment of the impact of the HOPE program via secondary outcomes will be used to assess signals of efficacy in a trial context. METHODS: Participants were drawn from an opportunity sample, referred by Macmillan Cancer Support, and were invited via email to participate in the study (N=61). Primary outcomes were rates of recruitment, retention, follow-up, completion and adherence, sample size and effect size estimation, and assessment of progression criteria for a definitive trial. Secondary outcomes were self-report measures of participants' positive mental well-being, depression, anxiety, and patient activation (ie, confidence in managing their cancer). The intervention and data collection took place on the web. RESULTS: The recruitment rate was 77% (47/61). A total of 41 participants completed the baseline questionnaires and were randomized to either the IG (n=21) or the waitlist CG (n=20). The retention rate (attending all program sessions) was greater than 50% (all: 21/41, 51%, IG: 10/21, 48%; and CG: 11/20, 55%). The follow-up rate (completing all questionnaires) was greater than 80% (all: 33/41, 80%; IG: 16/21, 76%; and CG: 17/20, 85%). The completion rate (attending ≥3 sessions and completing all questionnaires) was greater than 60% (all: 25/41, 61%; IG: 13/21, 62%; and CG: 12/20, 60%). Engagement data showed that participants viewed between half (5.1/10, 51%) and three-quarters (12.2/16, 76%) of the pages in each session. CONCLUSIONS: All progression criteria for a definitive trial were met, as supported by the primary outcome data. The IG showed improved postprogram scores on measures of positive mental well-being, depression, anxiety, and patient activation. A full-scale trial of the digital HOPE program for people with cancer will allow us to fully evaluate the efficacy of the intervention relative to a CG. TRIAL REGISTRATION: ISRCTN Registry ISRCTN79623250; http://www.isrctn.com/ISRCTN79623250. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/24264.

Sleep Disruption and Depression, Stress and Anxiety Levels in Women With Polycystic Ovary Syndrome (PCOS) During the Lockdown Measures for COVID-19 in the UK.

Background: Lockdown measures have been enforced globally in response to the COVID-19 pandemic. Given the comorbidity burden in women with polycystic ovary syndrome (PCOS), these lockdown measures may have a particularly negative impact on sleep health, quality of life (QoL), and depression/stress levels in this population. The aim of this study was to explore whether such potential problems were present in women with PCOS during the COVID-19 lockdown in the UK. Methods: UK women with PCOS were recruited through social media into a cross-sectional study during the COVID-19 lockdown. The study survey was delivered online, and included demographic and COVID-19 relevant questions, as well as validated questionnaires/scales, namely the Insomnia Severity Index (ISI), Depression Anxiety and Stress Scale (DASS-21), and PCOSQOL questionnaire. Results: Three hundred and thirty-three women with PCOS [median age: 30.0 (9.0) years] were recruited. Participants were dichotomized based on responses regarding the impact of COVID-19 restrictions on their sleep [negative (N = 242) vs. no/positive (N = 91) impact]. No differences were noted between groups regarding age, time since PCOS diagnosis, body mass index, or number of comorbidities. Based on the ISI, 44.2% of participants reporting a negative impact on sleep exhibited at least moderately severe clinical insomnia. Compared to those who reported no/positive effect on sleep, the participants reporting a negative impact on sleep also reported poorer QoL, based on the total PCOSQOL score, with a greater impact of PCOS and poorer mood in the corresponding PCOSQOL domains. Based on the DASS-21, the latter also had statistically higher depression and stress levels compared to the former. Finally, for this cohort significant inverse correlations were noted between the ISI and PCOSQOL scores (total and domain scores), whilst the DASS-21 and ISI scores were positively correlated (all p-values <0.001). Conclusion: The majority of recruited UK women with PCOS reported that the COVID-19 lockdown had a negative impact on their sleep, which was also associated with impaired QoL and higher depression/stress levels. Whilst further research is required, women with PCOS should be considered a vulnerable population that may experience an adverse impact on sleep, QoL and mental health well-being due to lockdown measures during the COVID-19 pandemic.

Bariatric Surgery and COVID-19: What We Have Learned from the Pandemic in Iran: a Retrospective Observational Cohort Study.

PURPOSE: Little is known about the symptoms of coronavirus disease 2019 (COVID-19) on patients with morbid obesity following bariatric surgery (BS) in Iran. Thus, we sought to investigate the symptoms and effect of COVID-19 in patients with morbid obesity following, or candidates for, BS in Iran. MATERIALS AND METHODS: In this retrospective observational cohort study, we enrolled 236 morbid obese patients following (surgical group) or candidates (nonsurgical group) for bariatric surgery. Demographics, probable COVID-19 incidence, acute and persistent COVID-19 symptoms, and clinical outcome parameters of bariatric patients and candidates for BS were compared. The incidence of probable COVID-19 was assessed including the clinical definition of probable case, according to World Health Organization criteria. RESULTS: The incidence of probable COVID-19 among surgical and nonsurgical groups was significantly different (20.6% vs 26.08%, respectively, p = 0.046). The probable case of surgical patients had a shorter length of symptoms and hospitalization duration, and a lower proportion of admission in ICUs and hospitals with respect to nonsurgical patients (p < 0.001). Surgical patients had a greater prevalence of persistent symptoms including anorexia, food intolerance, and anosmia-hyposmia than nonsurgical patients. Moreover, surgical patients with probable COVID-19 had a significantly higher proportion of diabetic patients than surgical patients without probable COVID-19 (20% vs 9.3%). CONCLUSION: These findings highlight the need to evaluate the persistent symptoms of COVID-19 and the importance of nutritional support for at least several weeks after COVID-19 symptom onset. Moreover, it seems that COVID-19 incidence in post-bariatric surgery patients could reduce the effectiveness of bariatric surgery in the resolution of diabetes.

Uncertainty, Anxiety and Isolation: Experiencing the COVID-19 Pandemic and Lockdown as a Woman with Polycystic Ovary Syndrome (PCOS).

Background: The COVID-19 pandemic and the related lockdown measures presented a significant risk to physical and mental wellbeing in affected populations. Women with polycystic ovary syndrome (PCOS) are predisposed to several cardio-metabolic risk factors which increase the susceptibility to severe COVID-19 and also exhibit increased likelihood of impaired mental health wellbeing. Therefore, these women who usually receive care from multiple primary and specialist healthcare services may be disproportionately impacted by this pandemic and the related restrictions. This study aimed to explore the lived experience of the first UK national lockdown as a woman with PCOS. Methods: As part of a larger cross-sectional study, 12 women with PCOS living in the UK during the first national COVID-19 lockdown were recruited to a qualitative study. Telephone interviews were conducted in June/July of 2020, and data collected were subjected to thematic analysis. Results: Five themes were identified. "My PCOS Journey" describes participants' experiences of diagnosis, treatment and ongoing management of their PCOS. "Living Through Lockdown" describes the overall experience and impact of the lockdown on all aspects of participants' lives. "Self-care and Managing Symptoms" describe multiple challenges to living well with PCOS during the lockdown, including lack of access to supplies and services, and disruption to weight management. "Healthcare on Hold" describes the uncertainty and anxiety associated with delays in accessing specialised healthcare for a range of PCOS aspects, including fertility treatment. "Exacerbating Existing Issues" captures the worsening of pre-existing mental health issues, and an increase in health anxiety and feelings of isolation. Conclusion: For the women with PCOS in this study, the COVID-19 pandemic and the first national lockdown was mostly experienced as adding to the pre-existing challenges of living with their condition. The mental health impact experienced by the study participants was increased due to lack of access to their normal support strategies, limitations on healthcare services and uncertainty about their risk of COVID-19.

Does vitamin C supplementation exert profitable effects on serum lipid profile in patients with type 2 diabetes? A systematic review and dose-response meta-analysis.

Previous studies have reported that vitamin C supplementation may decrease lipid profile in patients with type 2 diabetes mellitus (T2DM). This systematic review and meta-analysis evaluated the influence of vitamin C supplementation on lipid profile in patients with T2DM. Studies examining the effects of vitamin C supplementation on lipid profile in patients with T2DM, published up to November 2020, were identified through PubMed, SCOPUS, and Embase databases. 15 studies, including 872 participants, were included and analyzed using a random-effects model to calculate weighted mean differences (WMDs) with 95% confidence intervals (CI). Findings from 15 studies indicated that vitamin C supplementation significantly decreased Triglyceride (TG) (WMD: -16.48 mg/dl, 95% CI (-31.89, -1.08), P < 0.001) and total cholesterol (TC) (WMD: -13.00 mg/dl, 95% CI (-23.10, -2.91), P < 0.001) in patients with T2DM. However, vitamin C supplementation failed to improve LDL and HDL. The meta-regression analysis suggested that lipid profile improvement was affected by duration of vitamin C treatment. Dose-response analysis showed that vitamin C supplementation changed LDL significantly based on vitamin C dose. According to our findings, vitamin C supplementation significantly improved lipid profile via decreases in TG and TC. However, vitamin C failed to affect LDL and HDL in diabetic populations. It appears that vitamin C supplementation is more beneficial to lipid profile in long-term vs. short term interventions.

Changes in Physical Activity and Sedentary Behaviour Due to Enforced COVID-19-Related Lockdown and Movement Restrictions: A Protocol for a Systematic Review and Meta-Analysis.

Prolonged lockdown/restriction measures due to the COVID-19 pandemic have reportedly impacted opportunities to be physically active for a large proportion of the population in affected countries globally. The exact changes to physical activity and sedentary behaviours due to these measures have not been fully studied. Accordingly, the objective of this PROSPERO-registered systematic review is to evaluate the available evidence on physical activity and sedentary behaviours in the general population during COVID-19-related lockdown/restriction measures, compared to prior to restrictions being in place. Defined searches to identify eligible studies published in English, from November 2019 up to the date of submission, will be conducted using the following databases: CENTRAL, MEDLINE, EMBASE, CINAHL, SPORTDiscus, PSYCinfo, Coronavirus Research Database, Public Health Database, Publicly Available Content Database, SCOPUS, and Google Scholar. The applied inclusion criteria were selected to identify observational studies with no restrictions placed on participants, with outcomes regarding physical activity and/or sedentary behaviour during lockdown/restriction measures, and with comparisons for these outcomes to a time when no such measures were in place. Where appropriate, results from included studies will be pooled and effect estimates will be presented in random effects meta-analyses. To the best of our knowledge, this will be the first systematic review to evaluate one complete year of published data on the impact of COVID-19-related lockdown/restriction measures on physical activity and sedentary behaviour. Thus, this systematic review and meta-analysis will constitute the most up-to-date synthesis of published evidence on any such documented changes, and so will comprehensively inform clinical practitioners, public health agencies, researchers, policymakers and the general public regarding the effects of lockdown/restriction measures on both physical activity and sedentary behaviour.

Medicinal plant compounds as promising inhibitors of coronavirus (COVID-19) main protease: an in silico study.

The novel Coronavirus (COVID-19) has spread rapidly across the globe and has involved more than 215 countries and territories. Due to a lack of effective therapy or vaccine, urgent and concerted efforts are needed to identify therapeutic targets and medications. COVID-19 main protease represents a major target for drug treatment to inhibit viral function. The present study sought to evaluate medicinal plant compounds as potential inhibitors of the COVID-19 main protease using molecular docking and molecular dynamic analysis. The PDB files of COVID-19 main protease and some medicinal plant compounds were retrieved from the Protein Data Bank (http://www.rcsb.org) and Pubchem server, respectively. The Gromacs software was used for simulation studies, and molecular docking analysis was done using Autodock 4.2. The COVID-19 main protease simulation, compared with some phytochemicals docked to the COVID-19 main protease, were analyzed. Glabridin, catechin, and fisetin had the greatest tendency to interact with the COVID-19 main protease by hydrogen and hydrophobic interactions. Docking of these phytochemicals to COVID-19 main protease led to an increase in the radius of gyration (Rg), decrease in the Root mean square fluctuation (RMSF), and induced variation in COVID-19 main protease secondary structure. The high tendency interaction of glabridin, catechin, and fisetin to COVID-19 main protease induced conformational changes on this enzyme. These interactions can lead to enzyme inhibition. This simulated study indicates that these phytochemicals may be considered as potent inhibitors of the viral protease; however, more investigations are required to explore their potential medicinal use.Communicated by Ramaswamy H. Sarma.

Association of Vitamin D Status with SARS-CoV-2 Infection or COVID-19 Severity: A Systematic Review and Meta-analysis.

This systematic review was conducted to summarize and clarify the evidence on the association between 25-hydroxyvitamin-D [25(OH)D] concentrations and coronavirus disease 2019 (COVID-19) risk and outcomes. PubMed, Scopus, and Web of Science databases and Google Scholar were searched up to 26 November 2020. All retrospective and prospective cohort, cross-sectional, case-control, and randomized controlled trial studies that investigated the relation between 25(OH)D and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and COVID-19 severity were included. Thirty-nine studies were included in the current systematic review. In studies that were adjusted (OR: 1.77; 95% CI: 1.24, 2.53; I2: 44.2%) and nonadjusted for confounders (OR: 1.75; 95% CI: 1.44, 2.13; I2: 33.0%) there was a higher risk of SARS-CoV-2 infection in the vitamin D deficiency (VDD) group. Fifteen studies evaluated associations between VDD and composite severity. In the studies that were adjusted (OR: 2.57; 95% CI: 1.65, 4.01; I2 = 0.0%) and nonadjusted for confounders (OR: 10.61; 95% CI: 2.07, 54.23; I2 = 90.8%) there was a higher severity in the VDD group. Analysis of studies with crude OR (OR: 2.62; 95% CI: 1.13, 6.05; I2: 47.9%), and adjusted studies that used the Cox survival method (HR: 7.67; 95% CI: 3.92, 15.03; I2: 0.0%) indicated a significant association of VDD with mortality, while in adjusted studies that used logistic regression, no relation was observed (OR: 1.05; 95% CI: 0.63, 1.75; I2: 76.6%). The results of studies that examined relations between VDD and intensive care unit (ICU) admission, pulmonary complications, hospitalization, and inflammation were inconsistent. In conclusion, although studies were heterogeneous in methodological and statistical approach, most of them indicated a significant relation between 25(OH)D and SARS-CoV-2 infection, COVID-19 composite severity, and mortality. With regard to infection, caution should be taken in interpreting the results, due to inherent study limitations. For ICU admission, inflammation, hospitalization, and pulmonary involvement, the evidence is currently inconsistent and insufficient.

A Digital Program (Hope) for People Living With Cancer During the COVID-19 Pandemic: Protocol for a Feasibility Randomized Controlled Trial.

BACKGROUND: During the COVID-19 lockdown period in the United Kingdom that began on March 23, 2020, more than a quarter of a million people with cancer reported worsening mental health. Help to Overcome Problems Effectively (Hope) is a self-management program for people with cancer, designed to provide support for distress, unmet needs, and poor psychological health. In light of social distancing during the COVID-19 pandemic, digital delivery of the Hope Programme has become ever more vital for people with cancer. Previous pre-post studies of the digital Hope Programme have found reduced anxiety and depression and improved well-being for people with cancer. However, evaluation of this evidence has been limited by the lack of a control group in these previous studies. OBJECTIVE: We now present a protocol for a feasibility randomized controlled trial of the digital Hope Programme for people with cancer during the COVID-19 pandemic. Primary outcomes will be recruitment, dropout, and adherence rates, and estimations of sample and effect size. To detect signals of efficacy, secondary outcomes will be participant mental health and well-being. METHODS: Participants will be recruited by Macmillan Cancer Support (MCS) through their social media networks. The study will employ a feasibility wait-list randomized controlled trial (RCT) design, with people with cancer being randomized to join the digital Hope Programme immediately (intervention group [IG]) or join a 6-week waiting list (wait-list control group [WLCG]) with a 1:1 allocation ratio. Participants will complete digital measures of depression, anxiety, mental well-being, and confidence in managing their own health. Online questionnaires will be administered preprogram and 6 weeks postprogram. RESULTS: All people who had requested access to the Hope Programme from MCS (N=61) will be invited to participate in the trial. Baseline data collection commenced in April 2020, and the Hope Programme began for the IG in May 2020 and for the WLCG in June 2020. Postprogram data collection was completed by the end of August 2020. CONCLUSIONS: This feasibility study will provide data to inform the design of a future definitive trial. Wider-scale provision of the digital Hope Programme has potential to improve the lives of thousands of people with cancer and reduce the burden on health care providers during these unprecedented times. TRIAL REGISTRATION: ISRCTN Registry ISRCTN79623250; http://www.isrctn.com/ISRCTN79623250. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/24264.