Implementation of a nurse-led self-management support intervention for patients with cancer-related pain: a cluster randomized phase-IV study with a stepped wedge design (EvANtiPain)

Abstract

Background: Pain self-management support interventions were effective in controlled clinical trials and meta analyses. However, implementation of these complex interventions may not translate into identical effects. This paper evaluates the implementation of ANtiPain, a cancer pain self-management support intervention in routine clinical practice according to the Reach Efficacy-Adoption Implementation Maintenance framework. Methods: In this cluster randomized study with a stepped wedge design, N = 153 adult patients with cancerrelated pain were recruited from 01/17 to 05/18 on 17 wards of 3 hospitals in Vienna, Austria. ANtiPain entailed a face-to-face in-hospital session by a trained nurse to prepare discharge according to key strategies, information on pain self-management, and skills building. After discharge, cancer-pain self-management was coached via phone calls. Patient-level data were collected at recruitment, and 2, 4 and 8 weeks after discharge via postal or online questionnaire. Primary outcome was pain interference with daily activities. Secondary outcomes included pain intensity, self-efficacy, and patient satisfaction. Organizational-level data (e.g., on implementation procedures) were collected by study or intervention nurses. The mixed model to analyze patient-level data included a random intercept and a random slope for individual and a random intercept for ward.

Effects of nurse‐led nonpharmacological pain interventions for patients with cancer: A systematic review and meta‐analysis

“…Pain was measured to determine relief in the intensity or severity of pain after NPIs in all 22 studies. Pain status was evaluated using the Brief Pain Inventory (BPI) ( n = 11) (Jahn et al, 2014; Kim et al, 2013; Koller et al, 2018; Kroenke et al, 2010; Kwekkeboom et al, 2012; Oldenmenger et al, 2011; Raphaelis et al, 2020; Thomas et al, 2012; van der Peet et al, 2009; Ward et al, 2008, 2009), a visual analogue scale (VAS) ( n = 5) (Burrai et al, 2014; Huang et al, 2010; Jane et al, 2011; Sharif Nia et al, 2017; Wilkie et al, 2010), a numeric rating scale (NRS) ( n = 3) (Koller et al, 2013; Quinlan‐Woodward et al, 2016; Rustoen et al, 2012, 2014), the M.D. Anderson Symptom Inventory (MDASI) ( n = 2) (Yeh et al, 2016; Wyatt et al, 2017), and the Short‐Form of the McGill Pain Questionnaire (SF‐MPQ) ( n = 1) (Li et al, 2011).…”

The influence of telehealth-based cancer rehabilitation interventions on disability: a systematic review

“…First, inclusion of only randomized controlled trials may have led us focus on efficacy trials in academic settings and miss pragmatic trials in clinical settings, including those stimulated by the COVID-19 pandemic. Although there were eleven articles published between 2020 and 2021 [ 32 , 37 , 41 , 46 , 50 , 62 , 71 , 76 , 80 , 84 , 90 ], no articles took place during or referenced the COVID-19 pandemic. Future research should consider differences among pre-, during-, and post-pandemic telehealth-based cancer rehabilitation intervention research in terms of populations reached, functional measures used and associated outcomes, as well as technology platforms utilized.…”

Recruitment and implementation challenges were common in stepped-wedge cluster randomized trials: Results from a methodological review

“…An adaptation of the analysis strategy was reported in four trials; three performed sensitivity analyses and one trial adapted the main analysis by excluding the period affected by inclusion issues. In one trial, sensitivity analyses to assess the impact of recruitment challenges qualitatively modified the results (from negative to positive) [13].…”