Outpatients with cancer and their family caregivers : a mixed methods research program evaluating a pain self-management intervention, exploring learning processes, and investigating constipation severity

Worldwide, medical advancements are rapidly increasing the number of patients with cancer and survivors.In Switzerland alone, 41,000 new cases of cancer are reported every year.As this increase strains local healthcare systems, more and more people are receiving care in outpatient clinics. Therefore, patients and their family caregivers (FCs) need manage the effects of their illnesses and therapies at home.
While cancer typically involves diverse symptoms, pain is one of the most frequent and distressing. It can occur in patients with cancer at any time, its incidence increases over the course of the disease; and pain trajectories are frequently complex and dynamic.Starting with adequate assessment, pain management should focus on pharmacological therapy, possibly complemented by non-pharmacological options. However, side effects can limit analgesics’ net value. One particularly common and distressing side effect, constipation, can accompany non-opioid analgesics. Opioid-induced constipation (OIC) is highly prevalent (50-100%) in patients with cancer.While certain OIC-predictive factors (e.g., opioid type, old age, low levels of physical activity) have been identified, it remains unclear which patient characteristics have the strongest influence on OIC.
Despite effective treatment options, various barriers separate over 40% of patients with cancer from appropriate pain management. In addition to healthcare professional- and system-related hurdles, patients’ personal characteristics can impede pain management. Further, effective pain self-management requires healthcare-specific knowledge and skills. However, as patients with cancer and their FCs commonly assume home self-management tasks with little or no preparation, psychoeducational interventions to help them develop core pain self-management competencies are highly recommended.
In the four most recent systematic reviews, the effectiveness of psychoeducational interventions to support patients in their cancer pain self-management was explored.While the results demonstrated statistically significant reductions in pain intensity and increases in knowledge about cancer pain management, these effects were moderate at best.Furthermore, the reviewed interventions varied greatly regarding type, duration, and content.Therefore, which intervention was most effective remains unclear. A further limitation is that these types of interventions have never been tested in German-speaking outpatients. In addition, as highlighted in further systematic reviews,only few studies have evaluated interventions to support FCs in pain management. And while the provision of a psychoeducational intervention can improve knowledge regarding cancer pain management, it is not entirely clear how the learning that led to these improvements can be facilitated or hampered. Finally, little is known about characteristics associated with inter-individual differences regarding the severity of constipation as one of the most common side effects of strong analgesics.
To address these gaps, this research program is methodologically founded on a mixed methods research approach. In addition, one promising psychoeducational intervention identified in earlier meta-analyses, the PRO-SELF© Pain Control Program (PCP, provided the basis for the adapted German PRO-SELF© Plus PCP. The latter was tested in a Swiss multi-centre randomized controlled trial (RCT) as part of this thesis. Finally, data from a previously conducted RCT in the U.S. that compared two doses of the PRO-SELF© Plus PCP were used to analyze predictors of constipation severity.
The aims of this thesis were threefold (Chapter 2). First, to evaluate the efficacy of a psychoeducational intervention – the adapted German PRO-SELF© Plus PCP – in decreasing outpatients’ with cancer average and worst pain intensity compared with usual care. Further, we explored the intervention’s effect on associated symptoms and other selected patient outcomes as well as patients’ and FCs’ experiences with pain management and study participation. Second, we aimed to test the efficacy of the adapted German PRO-SELF© Plus PCP at improving cancer pain management knowledge and self-efficacy, to qualitatively explore patients’ and FCs’ learning processes during the intervention and to interpret the results by merging quantitative and qualitative study results. Third, we aimed to identify demographic, clinical, and symptom characteristics associated with higher constipation severity in cancer outpatients with unrelieved pain.
This thesis’s first article presents the original study plan for the entire thesis, including an overview of the study procedures and a detailed description of the intervention’s content (Chapter 3). It also presents the overarching theoretical frameworks – Brant et al.’s “New Symptom Management Model” (SMM) and Bandura’s Social Learning Cognitive Theory (SLCT).
To address the first aim, we conducted an RCT with post-trial interviews (Chapter 4). Outpatients with cancer pain and their FCs were recruited from three Swiss university hospitals and randomized to the intervention group (IG) or the control group (CG). To collect primary and secondary outcomes, all of the participants completed questionnaires at enrolment (week 0) and at the study’s end (week 6). They completed a pain management diary. IG participants received weekly home visits or telephone calls from a specially educated intervention nurse (IN). She provided structured and tailored PCP components: education, skill-building, and nurse coaching. The CG received usual care. After having completed the RCT, interviews were conducted with IG and CG participants regarding their experiences with pain management and study participation. Primary (average and worst pain intensity) and secondary outcomes (e.g., pain relief) were evaluated. To analyze quantitative data, we used intention-to-treat analysis, descriptive statistics, and multilevel modelling (MLM).The qualitative study was guided by interpretive description.
From March 2016 until December 2018, 21 outpatients with cancer and seven FCs completed the study. Thirteen interviews post-RCT were conducted. This small number of participants reflected recruitment challenges. A significant group-by-time interaction (p = 0.044) was found for average pain. Most interviewed participants perceived the pain management diary, tailored intervention sessions, and weekly support as useful. None experienced study participation as burdensome. Due to the small sample size, findings must be interpreted with caution. However, the implementation of post-trial interviews increased our understanding of the efficacy of the adapted German PRO-SELF© Plus PCP. Clinicians might consider the use of a pain management diary and tailoring interventions to the individual patient’s situation and dynamic pain trajectories.
To address the second aim – to explore the learning processes from the adapted German PRO-SELF© Plus PCP – we analyzed data from the RCT (Chapter 5). A convergent mixed methods design with qualitative data embedded in the RCT was applied. Quantitative data (pain management knowledge, self-efficacy) were analyzed via MLM.Interpretive description guided the exploration of qualitative data, after which quantitative and qualitative findings were merged.
The group-by-time effect showed increases in patients‘ knowledge (p = 0.035) and self-efficacy (p = 0.007). During the intervention, patients’ and FCs’ learning from experience was supported by a competent and trustworthy intervention nurse who provided individualized intervention sessions. Joint reflections on the diary stimulated patients’ and FCs’ learning from experience. Experience of success reduced their fears of side effects and patients took their opioids more regularly. Some patients’ declining health hampered their pain self-management, while most IG participants felt more confident to adequately implement pain self-management after the study. Our mixed methods approach was useful to present contrasting cases. Competent and trustworthy nurses could support patients’ and FCs’ pain self-management. Jointly reflecting on experiences, using a diary and academic detailing can facilitate learning processes.
To address aim 3, we analyzed data from a previously conducted RCT in the U.S. (Chapter 6). In the parent RCT, Miaskowski et al.compared the efficacy of two doses – 6 vs. 10 weeks – of the PRO-SELF© Plus PCP. The analyses were based on 175 complete datasets of patients from eight U.S. outpatient cancer settings. At enrolment, patients completed demographic and symptom questionnaires. The primary outcome, constipation severity, was evaluated weekly using the Constipation Assessment Scale (CAS).To identify characteristics associated with higher CAS scores, we used hierarchical linear modelling (HLM).
At enrolment, while most patients were using stool softeners and/or stimulant laxatives, about 70% reported constipation (i.e., CAS score > 2; mean CAS score: 3.72 ± 3.11). At that measurement point, higher percentages of days with no bowel movement (BM), higher numbers of constipation treatments, higher stated anxiety scores, and higher analgesic side effects scores were associated with higher CAS scores (p < 0.05). Higher percentage of days with no BM was associated with inter-individual differences in constipation trajectories (p < 0.05). These findings underscore the high prevalence and large degree of inter-individual variability in constipation severity. The characteristics associated with worse CAS scores can help clinicians identify high-risk patients and initiate prompt interventions.
A discussion section concludes the thesis (Chapter 7). First, the adapted German PRO-Self© Plus PCP is critically reviewed in the light of the current literature. It becomes clear that the PCP is a comprehensive intervention in terms of its structure and content. In accordance with the literature,our results supported the provision of individualized intervention sessions in terms of mode of delivery, intensity, and content components by a well-educated clinician to facilitate patients’ and FCs’ pain self-management.
Next, the applied theoretical frameworks are critically discussed. The SMM and Bandura’s SLCT supported us in understanding the participants’ pain and side effects self-management and learning processes. However, since behavior change is a fundamental aspect to adequately implement self-management tasks, Michie’s behavior change theory68 could be supportive in any future trials. Further, methods are critically appraised to determine limitations and strengths. Recruitment challenges lead to a small sample size. A more in-depth mapping of contextual factors at the patient-, meso-, and macro-levels might have been helpful to overcome recruitment challenges.However, the application of MLM, HLM and the mixed methods approach strengthened the research program.
In addition, an outlook is given regarding the implementation of complex interventions such as the adapted German PRO-SELF© Plus PCP in clinical practice. Cancer outpatient settings can be a convenient place to counsel patients on their cancer pain and associated symptoms.Embedded in new models of care, such as the Chronic Care Model,healthcare organizations can improve the care of outpatients by fostering productive interactions between informed patients and experienced providers. However, the implementation of such new models of care can be challenging.EHealth solutions and the application of implementation science aspects could be considered in any further trials to speed the translation from evidence-based interventions into busy clinical outpatient settings.
To conclude, this research program addressed identified gaps in cancer research and care. First, we could identify characteristics associated with one of the most distressing analgesics’ side effects – namely constipation. Our findings underscore the high prevalence of constipation and that it remained an extremely difficult symptom to manage. Clinicians can use the characteristics found in this study to identify high risk patients and initiate more aggressive symptom management interventions. Second, the efficacy of the adapted German PRO-SELF© Plus PCP was evaluated in German-speaking outpatients with cancer for the first time. Third, patients’ and FCs’ learning processes associated with the intervention were explored. Application of a multiple methods, respectively mixed methods approach provided new insights into the efficacy of the intervention. In the RCT, the group-by-time effect showed a significant decrease in IG participants’ average pain as well as a significant increase in pain self-management knowledge and self-efficacy. Findings demonstrated most of the patients’ and FCs’ high satisfaction with the adapted German PRO-SELF© Plus PCP. The pain management diary, tailored intervention sessions, and weekly support were perceived as useful. Our mixed methods analysis illustrated that patients’ and FCs’ learning from experience was supported by an intervention nurse who they perceived as competent and trustworthy. For some patients, their declining health hampered pain self-management. After the study, most IG participants felt more confident to adequately implement pain self-management. Our findings underscored the need to support not only patients with cancer, but also their FCs in the pain and side effects self-management tasks in their daily lives. The provision of the adapted German PRO-SELF© Plus PCP that incorporates nurse coaching within the framework of self-care has the potential to enable patients with cancer and their FCs to learn how to adequately implement their pain and side effect self-management in their daily lives.