Patient Education to Promote Self-management in Pain Therapy

NCT04778384 | Unknown DMC

• 1 other identifier: Intervention_Pain_Therapy
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Monocentric, uncontrolled before / after study to evaluate the effectiveness of a patient education for oncological patients by nursing staff to promote self-management in pain therapy. The structured patient education (in the form of a micro-training) is intended to specifically promote pain self-management in oncological patients. In contrast to conventional training courses, this requires the patient to be actively involved in the process so that the skills learned can be used to optimally adapt the therapy on an individual level. Through the intervention, we postulate the advantage that the increased self-management of pain therapy improves the everyday functions of the patient, and by breaking down patient-related barriers and checking the accessibility of pain medication, the safety in dealing with pain therapy and thus patient satisfaction increases. Data is collected in two time series. First, data of patients with sham intervention (control intervention) is collected, then data is collected from patients with a structured micro-training (study intervention). Patients do not know which training series they belong to.

Conditions

Patient Empowerment

Outcome Measures

Primary Outcomes (1)

• Change in pain-related restriction of daily activities

  Questionnaire part 1: according to the Brief Pain Inventory Scale title: Do you feel restricted in everyday life because of the pain? 8 items with possible answers on a 5-pt-Likert-scale ranging from "not restricted" = 1pt to "completely restricted" = 5pts minimum score 8pts, maximum score 40pts with higher scores meaning a worse outcome

  20 months

Secondary Outcomes (2)

• Change in patient-related barriers

  20 months

• Confidence in handling pain medication, satisfaction with pain therapy and quality of life, restriction of the most important activities in everyday life

  20 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

30 patients receive micro-training based on a checklist \& targeted discussion / dismantling of patient-related barriers based on the answers in the second part of the questionnaire (BQII Barriers Questionnaire)

Behavioral: Micro-training to promote self-management in pain therapy

Control Group

SHAM COMPARATOR

30 patients receive a sham intervention: an unstructured conversation is carried out. Patient questions are answered correctly, but there is no training, rather patient information.

Other: Sham intervention

Interventions

Micro-training to promote self-management in pain therapy BEHAVIORAL

Micro-training according to the checklist \& targeted discussion / dismantling of patient-related barriers based on the answers in the second part of the questionnaire (BQII Barriers Questionnaire) In this discussion, the nurses give their opinion on any patient-related barriers that become apparent after completing the second part of the questionnaire. This is not done according to a fixed template, but with the specialist knowledge and everyday experience of the nurse.

Intervention Group

Sham intervention OTHER

An unstructured conversation is carried out. Patient questions are answered correctly, but there is no training, rather patient information.

Control Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Lack of consent
• Insufficient knowledge of German
• Cognitive deficits

Sponsors & Collaborators

• Luzerner Kantonsspital: lead

Study Sites (1)

Luzerner Kantonsspital

Lucerne, 6004, Switzerland

RECRUITING

Related Publications (1)

• Raphaelis 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 BACKGROUND

MeSH Terms

Conditions

Patient Participation

Interventions

Analgesia

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• Fabia Buettcher, MD

  Luzerner Kantonsspital

  STUDY CHAIR

Central Study Contacts

Fabia Buettcher, MD

CONTACT

+41 41 205 1344; fabia.buettcher@luks.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients do not know which training series they belong to.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Data analysis with statistical process control: Data is collected in two time series. First, data of patients with sham intervention (control intervention) is collected, then data is collected from patients with a structured micro-training (study intervention).

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 3, 2021
• Study Start: April 19, 2021
• Primary Completion: December 31, 2022
• Study Completion: April 30, 2023
• Last Updated: April 11, 2022

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)