Evaluating a complex intervention: A process evaluation of a psycho-education program for lung cancer patients receiving palliative radiotherapy

Carmen WH Chan
Professor, The Nethersole School of Nursing, The Chinese University of Hong Kong, Sha Tin, NT, Hong Kong, P.R. China

Alison Richardson
Clinical Professor of Cancer Nursing and End of Life Care, School of Health Sciences, University of Southampton, UK

Janet Richardson
Professor of Health Service Research, Faculty of Health, University of Plymouth, Plymouth, UK

PP: 234 - 244

Abstract

This study was to examine the integrity of intervention delivery and identify precursory factors contributing to successful delivery and the effectiveness of a psycho-educational intervention comprising progressive muscle relaxation and health education in patients receiving palliative lung cancer radiotherapy. This mixed methods study employed both quantitative and qualitative methods to investigate intervention integrity and to identify key precursory factors among 70 Hong Kong Chinese lung cancer patients. Results show that the intervention conducted by two support nurses, in line with that planned at the outset of the study, achieved a high degree of consistency. Full adherence to the 20-minute muscle relaxation component was an important factor contributing to better symptom management. Other contributing factors included use of supplementary audio and reading materials and frequent self-practice of muscle relaxation. Reinforcement strategies, together with the use of supplementary learning materials and a flexible approach to progressive muscle relaxation, are recommended for future research.

Keywords

psycho-education, process evaluation, palliative care, advance lung cancer

Article Text

Psychoeducational interventions (PEIs) are considered to be complex interventions since they are made up of several components and involve the active participation of patients and interveners (Campbell et al 2000).  It is not easy to define 'active ingredients' of such interventions as they are built up from the nature of the intervention (for example dose and frequency), and the specification of delivering the intervention (for example type of intervener and their required skill).  Complex interventions, even with random assignment, can violate the assumptions of traditional randomized controlled trial (RCT), as there may be variations in the delivery of the dose and participation level of the patient in the clinical environment that may threaten the integrity of the intervention.  Integrity is the degree to which the intervention is carried out as planned (Campbell et al 2000).   Hodges et al (2010) advocate all aspects of a psychological intervention need to be delineated adequately in order to assess and enhance intervention integrity.

One problem with evaluating and implementing a complex intervention is that the integrity of intervention delivery is likely to influence the extent to what it is meant to achieve. Arguably, it is fairly easy to standardize delivery of a drug. But quality of interventions, particularly psychosocial approaches, depending on the work of interveners may be much affected by other factors, such as their training, and quality of associated written materials. There is growing evidence that variation in mode of delivery results in very different outcomes. Two school-based interventions designed to increase fruit and vegetable intake (Resnicow et al 1998) and physical activity (Saunders et al 2006) reported a direct correlation between intervention integrity and trial outcomes.

Consequently it is argued the simple RCT paradigm needs to be replaced with a more flexible pragmatic design that mirrors the complexity of intervention delivery (Campbell et al 2000). A pragmatic design allows interveners to treat patients slightly differently according to their needs and recognize patients play an active part in the outcome of an intervention, without sacrificing the quality and essential elements of an intervention (Richardson 2000).  In this type of design contextual factors, such as patients' attention or the way treatment is given, are optimized and evaluated in order to ensure the approach closely mirrors clinical practice (Richardson 2000).  To achieve this, and ensure integrity of the intervention, process evaluation is advocated by many researchers (Chan 2009; Billings 2000) as a particularly useful approach to examine the process of complex interventions against the planned criteria of a quality intervention.

Process evaluation involves investigation of how an intervention was delivered. Lack of intervention integrity can occur when specific activities provided to patients deviate from those originally planned; and when patients are exposed to partial or different components of the intervention and at different levels of strength according to individual patient needs or changes in the intervener's performance (Chan 2009).  Therefore, process evaluation may include different aspects of patient, intervener and intervention (e.g., dose and frequency) variables. Variability in responses to an intervention can be explained in light of these variables (Chan 2009; Richardson 2000; Sidani & Braden 1998).  For instance, poor patient compliance to the full intervention package may explain why an intervention fails to achieve the intended outcome.

The main study

A psychoeducational intervention (PEI) combining multiple cognitive, psychological and behavioral ingredients was developed to manage breathlessness, fatigue and anxiety for Hong Kong Chinese patients with advanced lung cancer undergoing palliative radiotherapy (Chan et al 2011).  It was an evidence-based intervention based on the results of a systematic review (Chan 2006) and previous palliative care program by Bredin (1999), Quinn (1999) and Frith (1991). A 40-minute educational package plus 20 minutes coaching of progressive muscle relaxation (PMR) was delivered to patients prior to the beginning of the course of radiotherapy and repeated once after three weeks.  The education package consisted of discussion and counseling on the selected symptoms and their self-care management, supplemented by leaflets and audio tapes. During the education sessions, patients were told the focus of the intervention and its outline.  First, patients were given preparatory information about the description and causes of the three symptoms.  They were then provided the opportunity to discuss their perception of these symptoms, and explore the meaning these 3 symptoms held for them personally.  They were encouraged to explore their hopes and realistic goals in living with these symptoms.  Since not all patients had experienced all symptoms at the week 1 session, the support nurse needed to ask patients to imagine and anticipate the occurrence of these symptoms and be prepared for them.  This explained and justified the need to repeat the same activities in week 3 when patients might have more experience of the symptoms. 

The support nurse also gave advice on self care strategies, and coaching in PMR.  Coaching in PMR included a brief introduction to the mechanism and function of the technique, a demonstration of the contraction and relaxation of each muscle group, and rehearsal of the technique performed by patients.

At the end of the session, the support nurse briefly explained the content of the information leaflet to the patients.  She also requested patients and family members read the leaflet and listen to the audio tape at their own time and pace.  Lastly, patients were encouraged to self-practice PMR daily. Other details of the intervention are reported elsewhere (Chan et al 2011).  The effectiveness of the PEI was evaluated through the pragmatic RCT and shown to have positive and significant outcome effects in managing the symptoms of breathlessness, fatigue, and anxiety and improve patients' functional ability.  This paper involves secondary analysis of process data extracted from the main study.

Aim of the study

The present paper focuses on the evaluation of the process of delivering the PEI during the main study.  The aims of this study were to: (1) examine the integrity of intervention delivery and (2) identify precursory factors that contribute to successful delivery and the effectiveness of the PEI among the 70 patients recruited to the intervention group.

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