Testing the feasibility and effects of a self-management support intervention for patients with cancer and their family caregivers to reduce pain and related symptoms (ANtiPain): Study protocol of a pilot study

Abstract

Despite effective treatment options, more than 40% of cancer patients receive inadequate pain management. Our previous pilot study resulted in substantial adaptations of a cancer pain self-management intervention, the German PRO-Self © Plus Pain Control Program originally developed in the United States. This program will be implemented into clinical practice at the Medical Center-University of Freiburg. The purpose of this multiple methods pilot study is to test the implementation regarding feasibility and effects in clinical practice. In a randomized, wait-list controlled pilot study, adult oncology in-patients of a palliative care consultation service with pain >3/10 will be recruited. The intervention will be performed by a specialized advanced practice nurse with an inhospital visit and, after discharge, via phone calls and visits. The follow-up will be personalized according to a clinical algorithm that factors in pain intensity, satisfaction with pain management, and patient adherence. The intervention includes structured and tailored components and is based on three key strategies: information, skill building and nurse coaching. The specific aims of this study are threefold: 1) to test the feasibility of the study and intervention procedures; 2) to establish effect sizes of main outcome variables (e.g. decrease pain intensity, reduce the number of patients with pain as main symptom) for subsequent power calculation; 3) to explore participants' experiences with pain self-management support and their view of burden and benefit from study participation in a qualitative substudy. During the study period, which includes three data collection time points (T0 before, T1 one week and T2 six weeks after discharge), data will be collected via field notes of study nurses and questionnaires of patients. The results of this pilot study will build the basis for a larger comparative effectiveness study in which long term outcomes of a cancer pain self-management intervention in clinical practice will be evaluated.

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)

“…Therefore, to make it clinically more realistic, the structure of the intervention, now called ANtiPain, was further revised. In particular, ANtiPain now has a more adaptable structure so that it can follow standard clinical care more flexibly whilst core components of the original intervention were kept (e.g., the three key components information, nurse coaching and skills building) [18]. In the second German pilot RCT (n = 39), pain intensity, pain interference with daily activities, and pain-related self-efficacy reduced non-significantly with moderate to high effect sizes with the adapted ANtiPain intervention, while patient-related barriers to cancer pain management improved significantly (p = .03) [16].…”

“…ANtiPain [15,16] and the original PRO-Self© Plus PCP [14] are based on the Theory of Symptom Management [27] and Bandura's Social Cognitive Theory [28]. We assume that it reduces barriers and thus changes pain self-management-related behavior leading to a reduction of pain interference with daily activities [16,18]. In addition, we assumed that the practical aspects of pain management (e.g., timing of analgesic medication in daily routine) would improve patient-related outcomes.…”

“…In addition, we assumed that the practical aspects of pain management (e.g., timing of analgesic medication in daily routine) would improve patient-related outcomes. A more detailed description of the intervention can be found elsewhere [16,18]. In short, ANtiPain entails structured (e.g., each patient is taught how to communicate their pain to health care providers) and tailored components.…”

“…Intervention nurses followed an intervention protocol, applied assessment instruments (e.g., to assess pain or barriers to pain management [30]), and were asked to use a pocket booklet about common analgesics. Corresponding laminated theme-cards were used to visualize topics for patients covered in the discussion [16,18]. During the follow-up calls, pain, side effects of the prescribed analgesic medication, as well as adherence to analgesics and given recommendations were assessed and re-discussed.…”

A Concept Analysis of Self-Management of Cancer Pain

“…Consequently, 6 studies were added to the 21 studies. Finally, 27 studies (23 English studies and 4 Japanese studies)[ 3 8 9 10 11 12 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 ] were used for the concept analysis of self-management of cancer pain.…”