Background Community- and strengths-based psychosocial interventions are central to mental health and psychosocial support guidelines, but rigorous evidence regarding the effectiveness of these interventions is limited. The complexity and variability that is inherent to many community-based psychosocial interventions requires innovative strategies in order to facilitate the comparability and synthesis across research studies without compromising the fit and appropriateness of interventions to specific study populations and context. Entre Nosotras is a community-based psychosocial intervention developed for migrant and host community women that is designed to be flexible enough to enable integration of external intervention components and adaptable to diverse study contexts and populations. This protocol describes a study that aims to evaluate the appropriateness, acceptability, and feasibility of integrating a standardized stress management intervention into Entre Nosotras. Methods This study will evaluate the appropriateness, acceptability, feasibility, and safety of intervention and research procedures for a cluster randomized comparative effectiveness trial conducted in Ecuador and Panamá with migrant and host community women. In this feasibility trial, we will allocate communities nested within the three study sites to the integrated Entre Nosotras + stress management intervention versus Entre Nosotras alone through stratified randomization. Migrant and host community women residing in these study communities who report low to moderate levels of distress will be allocated to the intervention condition that their community is assigned (n = 220 total). We will collect quantitative measures of psychosocial wellbeing, psychological distress, coping, social support, and functioning from study participants. We will collect quantitative measures of fidelity and facilitator competencies through observation and facilitator self-assessment. Data on appropriateness, acceptability, feasibility, and safety will be gathered from participants and facilitators through quantitative assessments at 0, 5, and 10 weeks post-enrollment and qualitative interviews conducted with all facilitators and a subset of 70 study participants during the post-intervention follow-up period. Discussion Results from this feasibility trial will determine whether a multi-site cluster randomized comparative effectiveness trial of an adaptable community-based psychosocial intervention for migrant and host community women is relevant, acceptable, and feasible. Trial registration ClinicalTrials.gov identifier: NCT05130944. Registered November 23, 2021—retrospectively registered.
Community-based psychosocial interventions are key elements of mental health and psychosocial support; yet evidence regarding their effectiveness and implementation in humanitarian settings is limited. This study aimed to assess the appropriateness, acceptability, feasibility and safety of conducting a cluster randomized trial evaluating two versions of a group psychosocial intervention. Nine community clusters in Ecuador and Panamá were randomized to receive the standard version of the Entre Nosotras intervention, a community-based group psychosocial intervention co-designed with community members, or an enhanced version of Entre Nosotras that integrated a stress management component. In a sample of 225 refugees, migrants and host community women, we found that both versions were safe, acceptable and appropriate. Training lay facilitators to deliver the intervention was feasible. Challenges included slow recruitment related to delays caused by the COVID-19 pandemic, high attrition due to population mobility and other competing priorities, and mixed psychometric performance of psychosocial outcome measures. Although the intervention appeared promising, a definitive cluster randomized comparative effectiveness trial requires further adaptations to the research protocol. Within this pilot study we identified strategies to overcome these challenges that may inform adaptations. This comparative effectiveness design may be a model for identifying effective components of psychosocial interventions.
Objectives: This study investigated key predictors that impacted QoL for patients with FL across EU5. Methods: Real world data were drawn from the FL Diseasespecific Programme TM -a point in time study administered to haem-oncologists who completed patient record forms for the next 8 consulting patients with FL in Q2/3 2017 across EU5. QoL analysis was conducted on those that completed a patient selfcompletion form (PSC). Statistical methods used included Spearman's rank correlation coefficient, bivariate analysis, and multiple linear regression. Results: Data analysis was conducted on 1,534 patients diagnosed with FL, of whom 591 completed a PSC. Patients that completed a PSC were more likely to be at 1 st line (31% vs 23%; p=0.0035), responding to treatment at time of study (21% vs 16%; p=0.0061) and experience fewer comorbidities (1.2 vs 1.3; p=0.0169) than those that didn't complete a PSC. Characteristics of patients that completed a PSC were: mean age 65.1 years (SD=11.3), patients were most commonly grade 2 and stage III (43%; 41%), on their 2 nd line of therapy (59%) and had an ECOG of 1 (53%). Multiple QoL measures (FACT and WPAI), ECOG score and presence of comorbidities were significantly correlated with the EQ5D-5L (p,0.05). Comorbidities and ECOG score were key predictors of the EQ5D-5L. Patients on later lines of therapy had worse QoL (line 1line 3; p-value), including EQ5D-5L (0.82-0.59; p,0.0001), FACT-G score (67.79-54.87; p,0.0001), and FACT-Lymphoma score (109.29-87.94; p,0.0001). With increasing lines of therapy, patients receiving induction therapy had better QoL compared to those on maintenance therapy (EQ5D-5L: 0.81-0.77; p=0.
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