Praxis Evaluation of a Pain Self-management Support Intervention for Oncology Patients: A Stepped Wedge Design Study

Background: Significant barriers to cancer pain management are patient-related. So far, cancer pain self-management support interventions have only been tested in strictly controlled settings of randomized controlled trials (RCT) and thus evidence for comparative effectiveness is lacking. Methods: This study includes a multicenter cluster RCT with a stepped wedge design and a qualitative substudy. The aim of the study is to evaluate the implementation of ANtiPain in clinical practice. The primary patient-related aim is to improve pain interference with daily activities. Secondary patient-related aims are pain intensity, barriers to pain management, self-efficacy, and quality of life. Secondary organization-related aims are nurse proficiency and satisfaction with cancer pain self-management support, participation rates, and implementation fidelity. Inclusion and exclusion criteria: On 17 wards in 3 hospitals in Vienna adult oncology patients will be included (n=150 pre-, n=150 post-implementation) if they are admitted to one of the participating wards, have pain ≥3 (0=no pain to 10=worst imaginable pain) or regular pain medication, able to understand German, discharged with pain self-management, and give informed consent. Patients with signs of disorientation that may severely limit pain self-management will be excluded. Interventions: Pre-implementation, patients receive standard care. Post-implementation, patients receive ANtiPain which is based on 3 key strategies: information, skills building and nurse coaching and consists of in-hospital sessions by staff nurses and follow-up phone calls after discharge. The implementation process will include training of the designated staff nurses, case discussions, as well as measures to ensure sustainability of the implementation (e.g., training of clinical nurse specialists). Procedures: Wards are randomized according to the stepped wedge plan. Patients will complete questionnaires at admission, and 2, 4 and 8 weeks after discharge. Nurse-level data will be collected before implementation and 1 and 3 months after implementation. Data on ward and hospital level will be collected at the beginning of the study. Statistical analysis: The statistical analysis will be conducted based on mixed models, with a random intercept for the respective ward and time as a covariate. Qualitative substudy: The qualitative substudy will comprise interviews with head and intervention nurses about their views of the implementation.

Sex

All

Minimum age

18 Years

Wards

Inclusion Criteria:

* ≥20% of oncology patients
* pre-selection by nursing director and clinical nurse specialists
* willing to participate

Patients

Inclusion Criteria:

* admission to one of the participating wards
* cancer-related pain ≥3 on 11-point numeric rating scale within the last week or
* have regular pain medication because of cancer-related pain
* are able to read and write German
* likely to be discharged with pain self-management
* willing to participate

Exclusion Criteria:

* if patients are showing signs of disorientation that may limit their ability to perform pain self-management at home as assessed by staff nurse

• DERIVEDRaphaelis S, Frommlet F, Mayer H, Koller A. 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). BMC Cancer. 2020 Jun 16;20(1):559. doi: 10.1186/s12885-020-06729-0. PMID 32546177