Psycho-Educational and Rehabilitative Intervention to Manage Cancer Cachexia (PRICC) for Advanced Patients and Their Caregivers: Lessons Learned from a Single-Arm Feasibility Trial.

BACKGROUND: Key elements in cancer cachexia (CC) management are personalized and multimodal interventions, but it is hard for some patients to follow programs based on several components. We examined the feasibility of a bimodal intervention, including a psycho-educational component and exercises, to support patients and their caregivers in managing CC; Methods: Prospective mixed-methods pilot study explored feasibility data, changes in patient-reported outcomes, and performance outcomes over time in a convenient sample of 30 consecutive CC patients and their caregivers. RESULTS: Twenty-four dyads consented to participate. Twenty dyads received at least two psycho-educational sessions, so the psycho-educational component was feasible for 83.3% of the sample. Six dyads participated in at least fourteen out of twenty-seven rehabilitation sessions, so the exercise program was feasible for 25.0% of the sample. Six dyads showed compliance greater than 50% for both components of the bimodal intervention. CONCLUSIONS: While we did not meet our primary feasibility endpoint and had mixed acceptability, our experience provides insight into the challenges and lessons learned in implementing a primary palliative care intervention for CC. More robust studies are needed to help clinicians understand the best exercise program for CC patients, to be included in a multimodal intervention.

Therapeutic education and physical activity are feasible and safe in hematologic cancer patients referred to chemotherapy: results of a randomized controlled trial.

PURPOSE: Although over 60% of patients with hematologic cancer report distressing fatigue, they often do not receive recommendations on fatigue management strategies. The aim of this pilot study was to estimate the feasibility of therapeutic education and physical activity (TEPA) by measuring the patients' adherence to this multidimensional intervention. The secondary aim was to estimate the impact of TEPA on clinical outcomes. METHODS: Patients with hematologic cancer participated in this single-center, open-label, randomized controlled trial. The control group (CG) received two educational group sessions on fatigue and physical activity. The experimental group (EG) received the two educational sessions plus six weekly individual sessions aimed at implementing a personalized physical exercise program. Follow-ups were at 1, 3, and 7 months. RESULTS: Forty-six patients referred to chemotherapy were included, corresponding to 54% of recruitment rate. Adherence reached 90% in the EG and 68% in the CG. Most patients (65% in EG and 64% in CG) attended a minimum of 80% of the planned sessions. Overall retention rate was 87% (85% in EG and 91% in CG). No adverse events were registered. No between-group differences were detected in fatigue (FACIT-F), psychological distress (NCCN Distress Thermometer), QoL (EORTC QLQ-C30), or functional exercise capacity (TUG test and 6MWT). Adherence to an active lifestyle, measured by a semi-structured interview, increased from 56.5 to 84% in the EG at 7 months (p = 0.02), whereas it decreased slightly in the CG (from 47.8 to 42.9%). CONCLUSION: Multidimensional rehabilitation interventions are feasible and safe in this population, and larger trials should focus on the efficacy of such approaches on clinically relevant outcomes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03403075.

Sex differences and rehabilitation needs after hospital discharge for COVID-19: an Italian cross-sectional study.

OBJECTIVES: COVID-19 can result in persistent symptoms leaving potential rehabilitation needs unmet. This study aims to describe persistent symptoms and health status of individuals hospitalised for COVID-19 according to the International Classification of Functioning, Disability and Health domains of impairments, limitations in activity, and participation restrictions. DESIGN: Cross-sectional study consisting in a telephone interview 3 months after hospital discharge. SETTING: This study was conducted during the first peak of the COVID-19 pandemic by the Local Health Authority of Reggio Emilia (Italy). PARTICIPANTS: Adult individuals discharged from hospital between April and June 2020 after COVID-19. EXCLUSION CRITERIA: hospitalisation for reasons other than COVID-19, inability to participate in the study, concomitant acute or chronic conditions causing disability. PRIMARY AND SECONDARY OUTCOME MEASURES: We assessed: dyspnoea (Medical Research Council), fatigue (Fatigue Severity Scale), mood disturbances (Hospital Anxiety and Depression Scale), limitations in activity (Barthel Index) and participation restrictions (Reintegration to Normal Living Index). We also collected data on sociodemographic characteristics, health status prior to COVID-19, COVID-related clinical manifestations and hospital care pathway up to discharge, rehabilitation interventions, accidental falls and emergency room access. RESULTS: 149 participants (men, 62%; average age 62 (±11) years) were enrolled, 35 of which (23%) were admitted to the intensive care unit (ICU) while hospitalised. Three months after hospital discharge, nearly half of the participants still suffered from dyspnoea (44%) or fatigue (39%). Almost all individuals (91.2%) recovered a good level of independence in activity of daily living, but 76% still suffered participation restrictions. Female sex was significantly associated with worse outcomes for all symptoms. CONCLUSIONS: Individuals who had moderate or severe COVID-19 may perceive persistent symptoms which may result in reduced social participation. Sex differences should be monitored, as women may recover more slowly than men. TRIAL REGISTRATION NUMBER: NCT04438239.

"Like before, but not exactly": the Qualy-REACT qualitative inquiry into the lived experience of long COVID.

BACKGROUND: Post-acute sequelae of SARS-CoV-2 infection (PASC) affect millions of individuals worldwide. Rehabilitation interventions could support individuals during the recovery phase of COVID-19, but a comprehensive understanding of this new disease and its associated needs is crucial. This qualitative study investigated the experience of individuals who had been hospitalized for COVID-19, focusing on those needs and difficulties they perceived as most urgent. METHODS: This naturalistic qualitative study was part of a single-center mix-method cross-sectional study (REACT) conducted in Italy during the first peak of the SARS-CoV-2 pandemic. The qualitative data collection took place through a telephone interview conducted 3 months after hospital discharge. The experience of individuals discharged after hospitalization for COVID-19 was investigated through the main research question - "Tell me, how has it been going since you were discharged?". Two secondary questions investigated symptoms, activities, and participation. Data were recorded and transcribed verbatim within 48 h. An empirical phenomenological approach was used by the researchers, who independently analyzed the data and, through consensus, developed an interpretative model to answer the research question. Translation occurred after data was analyzed. RESULTS: During the first peak of the COVID-19 pandemic, 784 individuals with COVID-19 were discharged from the hospitals of the Local Health Authority of the Province of Reggio Emilia (Italy); 446 were excluded due to the presence of acute or chronic conditions causing disability other than COVID-19 (n. 339), inability to participate in the study procedures (n. 56), insufficient medical documentation to allow for screening (n. 21), discharge to residential facilities (n. 25), and pregnancy (n. 5). Overall, 150 individuals consented to participate in the REACT study, and 56 individuals (60.7% male, average age 62.8 years ±11.8) were interviewed in June-July 2020, up to data saturation. Persistent symptoms, feelings of isolation, fear and stigma, emotional distress, a fatalistic attitude, and return to (adapted) life course were the key themes that characterized the participants' experience after hospital discharge. CONCLUSIONS: The experience as narrated by the participants in this study confirms the persistence of symptoms described in PASC and highlights the sense of isolation and psychological distress. These phenomena may trigger a vicious circle, but the participants also reported adaptation processes that allowed them to gradually return to their life course. Whether all individuals are able to rapidly activate these mechanisms and whether rehabilitation can help to break this vicious circle by improving residual symptoms remain to be seen. TRIAL REGISTRATION: ClinicalTrials.com NCT04438239.

Self-Management in Stroke Survivors: Development and Implementation of the Look after Yourself (LAY) Intervention.

OBJECTIVE: Self-management is recommended in stroke rehabilitation. This report aims to describe timing, contents, and setting of delivery of a patient-centered, self-management program for stroke survivors in their early hospital rehabilitation phase: the Look After Yourself (LAY) intervention. METHODS: After extensive literature search, the LAY intervention was developed by integrating the Chronic Disease Self-Management Program, based on the self-efficacy construct of social cognitive theory, with evidence-based key elements and input from stroke survivors. RESULTS: the LAY intervention aims to implement self-management skills in stroke survivors, enabling them to be active in goal setting and problem solving using action plans and to facilitate the critical transition from hospital to community. It includes both group sessions to facilitate sharing of experiences, social comparison, vicarious learning, and increase motivation and one-to-one sessions focused on setting feasible action plans and on teaching personalized strategies to prevent falls. Standardization is ensured by manuals for facilitators and patients. CONCLUSION: The LAY intervention is the first Italian program to support early self-management in stroke rehabilitation; it has been experimented and its efficacy proven in improving self-efficacy, mental health, and activities of daily living, and detailed results have been published. The LAY intervention is described according to the TIDieR checklist.

Psychoeducational and rehabilitative intervention to manage cancer cachexia (PRICC) for patients and their caregivers: protocol for a single-arm feasibility trial.

INTRODUCTION: Half of all patients with cancer experience cachexia, with the prevalence rising above 80% in the last weeks of life. Cancer cachexia (CC) is a complex relational experience that involves the patient-family dyad. There are no studies on the association between the psychoeducational component and the rehabilitative component of dyads for supporting more functional relationships in the management of CC.The primary objective of this study is to evaluate the feasibility of a psychoeducational intervention combined with a rehabilitative intervention on dyads.The secondary objective is to improve the quality of life (QoL) and acceptability of the intervention. METHODS AND ANALYSIS: This mixed-methods study with a nonpharmacological interventional prospective includes 30 consecutive cancer patients with cachexia and refractory cachexia and their caregivers, assisted by the Specialised Palliative Care Team. The recruitment will last 1 year. The intervention involves two components: (1) psychoeducational intervention: 3 weekly face-to-face consultations between dyads and trained nurses to help the dyads cope with involuntary weight loss and strengthening dyadic coping resources and (2) rehabilitation intervention: 3 biweekly educational sessions between dyads and trained physiotherapists focused on self-management, goal-setting, physical activity with three home exercise sessions per week.The primary endpoint will be in adherence to the intervention, indicated by a level of completion greater than or equal to 50% in both components. The secondary endpoints will be QoL (Functional Assessment of Anorexia-Cachexia Therapy), caregiver burden (Zarit Burden), physical performance (Hand-Grip strength and 30 seconds sit-to-stand test), and the acceptability of the intervention (ad hoc semi-structured interviews with the dyads and the healthcare professionals). ETHICS AND DISSEMINATION: The study was approved by the Ethics Committee Area Vasta Emilia Nord, Azienda USL-IRCSS Reggio Emilia, Italy, number: 73/2019/SPER/IRCCSRE. The authors will provide the dissemination of the results through publication in international scientific journals. TRIAL REGISTRATION NUMBER: NCT04153019.

Therapeutic Education and Physical Activity to Support Self-management of Cancer-related Fatigue in Hematologic Cancer Patients: Protocol of a Feasibility Randomized Controlled Trial.

INTRODUCTION: Hematologic malignancies account for nearly 8% of new cancer diagnosis in Italy. Cancer-related fatigue (CRF) is one of the most distressing symptoms reported by patients with cancer. As CRF has a multifactorial etiology, physical activity and therapeutic education may be beneficial for managing CRF, both during and after cancer treatment. However, there is a lack of evidence specific to hematologic malignancies. This paper describes the protocol of a feasibility study on Therapeutic Education and Physical Activity (TEPA) intervention to support self-management of CRF in patients with hematologic malignancies. METHODS: TEPA was addressed to newly diagnosed adult individuals with hematologic malignancy able to take part in a rehabilitation programme at the AUSL-IRCCS of Reggio Emilia. The protocol was developed in 2 phases. Phase I was an observational cohort study involving a convenience sample of 10 participants with the aim to evaluate the feasibility of the assessment schedule and to register longitudinal clinical data regarding CRF (FACIT-F), psychologic distress (NCCN Distress Thermometer), QoL (EORTC QLQ-C30), physical performance (TUG and 6MWT) and habitual level of physical activity during first months after diagnosis. Phase II (underway) is a feasibility randomized controlled trial (TEPA) involving a convenience sample of 40 participants and comparing 2 parallel active interventions (Therapeutic Education versus Therapeutic Education and Physical Activity) on top of usual care. The primary aim is to estimate the feasibility of TEPA, measured by the adherence rate to the intervention. Secondary aims are: to estimate the effect size of TEPA in terms of changes in CRF, psychological distress, QoL, physical performance and habitual level of physical activity (measured as in Phase I); to collect patient satisfaction, perception of usefulness of the TEPA intervention and data on long-term adherence to an active lifestyle. Data are collected in both phases at the time of diagnosis and then at 1-, 3- (completion of intervention) and 7-month follow-up. DISCUSSION: Data on feasibility and effect size of TEPA will be analyzed upon completion of Phase II, allowing us to design a large, adequately powered RCT to verify the effectiveness of this intervention on CRF management in patients with hematologic cancer. Trial registration: clinicaltrials.gov; Trial registration number: NCT03403075.

The Look After Yourself (LAY) intervention to improve self-management in stroke survivors: Results from a quasi-experimental study.

OBJECTIVE: To test the efficacy of a self-management intervention for stroke survivors vs. usual care. METHODS: Using a quasi-experimental study, participants were recruited from three public Italian hospitals. Questionnaires assessing self-efficacy (SSEQ), quality of life (SF-12), physical performance (SPPB), depression (GDS) and activities of daily living (MBI) were administered at baseline, discharge and two months after discharge. Mixed models with a propensity score were used between experimental group (EG) and control group (CG). Logistic models were used to compare the use of health services. RESULTS: Eighty-two stroke survivors were enrolled in the EG and 103 in the CG. Self-efficacy in self-management improved in the EG compared to the CG during hospitalization. Improvements from baseline to discharge were found in the EG in the mental component of SF-12 and in MBI. The EG were 8.9 times more likely to contact general practitioners after discharge and 2.9 times to do regular exercise than CG. Notably, EG with higher education benefitted more from the intervention. CONCLUSION: The intervention was efficacious in improving self-efficacy, mental health and activities of daily living. PRACTICE IMPLICATIONS: Structured educational interventions based on problem-solving and individual goal setting may improve self-management skills in stroke survivors.