NCT02891785: EvANtiPain

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

Completed NA Last updated 17 April 2019

What this trial tests

NA trial testing ANtiPain in Cancer Pain Self-management in 153 participants. Completed in 31 July 2018.

Timeline

5 January 2017

Primary endpoint
31 July 2018

31 July 2018

Quick facts

Lead sponsor	University of Vienna
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	supportive care
Enrollment	153
Start date	5 January 2017
Primary completion	31 July 2018
Estimated completion	31 July 2018
Sites	3 locations across Austria

Drugs / interventions tested

• ANtiPain

Conditions studied

• Cancer Pain Self-management — all drugs for Cancer Pain Self-management →

Sponsor

University of Vienna

Who can join

18 and older, any sex, with Cancer Pain Self-management. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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).
   Raphaelis S, Frommlet F, Mayer H, Koller A. · · 2020 · cited 9× · PMID 32546177 · DOI 10.1186/s12885-020-06729-0