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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02891785
Recruitment Status : Completed
First Posted : September 8, 2016
Last Update Posted : April 17, 2019
Sponsor:
Collaborators:
Martin-Luther-Universität Halle-Wittenberg
University of Lausanne
Information provided by (Responsible Party):
Antje Koller, PhD, University of Vienna

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cancer Pain Self-management Behavioral: ANtiPain Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Project "Improvement of Nurse-led Self-management Support for Patients With Cancer-related Pain": An Accompanying Cluster Randomized Study With a Stepped Wedge Design
Actual Study Start Date : January 5, 2017
Actual Primary Completion Date : July 31, 2018
Actual Study Completion Date : July 31, 2018

Arm Intervention/treatment
Experimental: ANtiPain intervention
ANtiPain is a cancer pain self-management support intervention administered by nurses in an intervention session while the patient is still hospitalized and via phone calls after discharge. ANtiPain is based on three key strategies: information, skill building and nurse coaching.
Behavioral: ANtiPain
After the implementation of ANtiPain, patients will receive cancer pain self-management support by trained staff nurses who follow the ANtiPain protocol. ANtiPain is based on 3 key strategies: Provision of information, skill building and nurse coaching. It consists of an in-hospital one-to-one session before discharge and a telephone follow up according to a clinical algorithm based on pain intensity, patient satisfaction with pain management and patient adherence. Patients will be given a booklet with corresponding info. The implementation process will include training of designated staff nurses, coaching activities based on case discussions on the ward, as well as measures to ensure sustainability of the implementation (e.g., training of ward managers and clinical nurse specialists).

No Intervention: standard care
Standard care will be described as part of the study.



Primary Outcome Measures :
  1. pain interference with daily activities TP1 [ Time Frame: Change from Baseline in pain interference with daily activities at 2 weeks after discharge ]
    7-item scale from Brief pain Inventory

  2. pain interference with daily activities TP2 [ Time Frame: Change from Baseline in pain interference with daily activities at 4 weeks after discharge ]
    7-item scale from Brief pain Inventory


Secondary Outcome Measures :
  1. pain intensity TP1 [ Time Frame: Change from Baseline in pain intensity at 2 weeks after discharge ]
    11-point numeric rating scale (0=no pain; 10=worst imaginable pain)

  2. pain intensity TP2 [ Time Frame: Change from Baseline in pain intensity at 4 weeks after discharge ]
    11-point numeric rating scale (0=no pain; 10=worst imaginable pain)

  3. BQII-G TP1 [ Time Frame: Change from Baseline in BQII-G scores at 2 weeks after discharge ]
    patient related barriers to cancer pain management

  4. BQII-G TP2 [ Time Frame: Change from Baseline in BQII-G scores at 4 weeks after discharge ]
    patient related barriers to cancer pain management

  5. Self Efficacy Scale TP1 [ Time Frame: Change from Baseline in Self Efficacy Scale scores at 2 weeks after discharge ]
    pain-related self-efficacy

  6. Self Efficacy Scale TP2 [ Time Frame: Change from Baseline in Self Efficacy Scale scores at 4 weeks after discharge ]
    pain-related self-efficacy

  7. Health-Related Quality of Life TP1 [ Time Frame: Change from Baseline in Health-Related Quality of Life scores at 2 weeks after discharge ]
    2 11-point numeric rating scales

  8. Health-Related Quality of Life TP2 [ Time Frame: Change from Baseline in Health-Related Quality of Life scores at 4 weeks after discharge ]
    2 11-point numeric rating scales

  9. participation rate [ Time Frame: count during study ]
    number of patients who are asked, versus number of participants who agree to participate in the study/in the intervention at study completion

  10. nurse-related outcomes 1 and 3 months after implementation [ Time Frame: Change from before implementation of ANtiPain until 1 and 3 months after implementation ]
    proficiency and satisfaction concerning pain self-management support

  11. pain interference with daily activities TP3 [ Time Frame: Change from Baseline in pain interference with daily activities at 8 weeks after discharge ]
    7-item scale from Brief pain Inventory

  12. pain intensity TP3 [ Time Frame: Change from Baseline in pain intensity at 8 weeks after discharge ]
    11-point numeric rating scale (0=no pain; 10=worst imaginable pain)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891785


Locations
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Austria
Krankenhaus Hietzing
Vienna, Austria, 1120
Wilhelminenspital
Vienna, Austria, 1160
Vienna General Hospital
Vienna, Austria
Sponsors and Collaborators
University of Vienna
Martin-Luther-Universität Halle-Wittenberg
University of Lausanne
Investigators
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Principal Investigator: Antje Koller, PhD University of Vienna, Faculty of Social Sciences, Institute of Nursing Science
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Antje Koller, PhD, PhD, University of Vienna
ClinicalTrials.gov Identifier: NCT02891785    
Other Study ID Numbers: UVienna
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Cancer Pain
Pain
Neurologic Manifestations
Antipain
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action