AzTrials
AzTrials

Patient EmpowermentNCT04778384

Patient Education to Promote Self-management in Pain Therapy

A study testing Micro-training to promote self-management in pain therapy in people with Patient Empowerment, run by Luzerner Kantonsspital at 1 site in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Patient Empowerment
What is being tested?
Micro-training to promote self-management in pain therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteSwitzerland
Study dates
19 Apr 2021to 30 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Oncology clinics outpatients with parenteral therapy with a new or escalated opioid pain therapy without exclusion criteria

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Fabia Buettcher, MD contact

+41 41 205 1344

fabia.buettcher@luks.ch

Switzerland1 site, 1 recruiting
  • Luzerner Kantonsspital

    Lucerne, 6004

    Irène Frank, Dr. sc. ETH, 412052835 ext. +41, irene.frank@luks.ch

    Daria Grossmann, 412056848 ext. +41, daria.grossmann@luks.ch

    Recruiting

Other trials in Switzerland

About this study

Official title: Evaluation of the Effectiveness of a Patient Education for Oncological Patients to Promote Self-management in Pain Therapy

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.

Read the detailed description

Nursing staff is trained to conduct the micro-training. The sham intervention is unstructured at the discretion of the respective nurse. They are only informed about the purpose of the sham intervention, the expected time frame and the course of a sample sham intervention.

First, the data collection of the group with control intervention is started until the required number of patients is recorded. As soon as these data are complete, the group with study intervention is recorded.

The patients are recruited from the oncological outpatient clinics. After the outpatient clinics before a parenteral therapy, they have a waiting period, during which the patient's consent is obtained. The patients are then taken to the intervention room for parenteral therapy. Here, the questionnaire is filled out before, during or after the therapy, and then the intervention with the nurse takes place. This process with a short reflection period must be designed in such a way because the indication for escalation of the opioid pain treatment is made during the oncological consultation which is the only possibility to recruit patients for this pilot study. The way the clinic runs today, the nursing staff is timewise only available for training patients with parenteral therapy. If the patients needed more time to think about it, they would have to be trained separately at a later point in time, which would only be established if the effectiveness of the patient training could be proven. Because the patients are not exposed to any risk from the planned interventions, this procedure is reasonable in our view.

In micro-training (study intervention), patients are taught structured knowledge based on the content of a checklist. In addition to pain recording, patients are trained in the use of basic and reserve pain medication and co-analgesics, the most common opioid side effects are discussed and how to react to them. It is also checked that the necessary prescriptions or medication have been given. Furthermore, after completing the BQII Barriers Questionnaire (second part of the questionnaire), patient-related barriers, i.e. concerns or fears of the patient with regard to pain therapy, become apparent. With a factual discussion and a professional weighing of advantages and disadvantages, the nurse tries to break down these barriers and thus promotes the patient's motivation for a well-adapted pain therapy. In the case of sham intervention (control intervention), there is only a conversation between the nurse and the patient. In this conversation the patient is picked up with his current knowledge about his pain therapy and any questions are answered correctly. However, there is no structured transfer of knowledge in the sense of patient training.

The data is recorded using a three-part questionnaire. The first part of the questionnaire contains questions regarding pain-related restrictions in everyday activities (using the Brief Pain Inventory as the standard for pain assessment of oncological patients as used by the Swiss Cancer League). The second part of the questionnaire deals with patient-related barriers using the BQII Barriers Questionnaire. The third part of the questionnaire consists of global questions: confidence in dealing with pain medication, satisfaction with pain therapy, restriction of the most important activities in everyday life and satisfaction with quality of life.

4 weeks after the intervention, patients are asked to fill in the same three-part questionnaire again. At that time, the questionnaire is sent to them by mail with a reply envelope.

Being tested
Micro-training to promote self-management in pain therapy, Sham intervention
Medical subject headings
Patient Participation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Micro-training to promote self-management in pain therapyBehavioural

    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.

  • Sham interventionOther

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

Study groups in NCT04778384
Study groupRoleWhat they receive
Intervention GroupExperimental30 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)
Receives: Behavioral: Micro-training to promote self-management in pain therapy
Control GroupSham comparator30 patients receive a sham intervention: an unstructured conversation is carried out. Patient questions are answered correctly, but there is no training, rather patient information.
Receives: Other: Sham intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 20 months

Secondary outcomes (2)
  1. Change in patient-related barriers

    Questionnaire part 2: according to the BQII Barriers Questionnaire Scale title: We are interested in your attitude towards pain therapy. Please tick the box that most applies to you.

    12 items with possible answers on a 5-pt-Likert-scale ranging from "completely disagree" = 1pt to "completely agree" = 5pts possible minimum score 12pts, possible maximum score 60pts with higher scores meaning a worse outcome (meaning higher barriers towards pain therapy)

    Measured: 20 months

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

    Questionnaire part 3: recorded with global questionsScale title: Please tick the box that most applies to you.

    4 global questions regarding self competence and satisfaction with pain therapy, the ability to fulfill the most important daily activity despite the pain and overall satisfaction with quality of life.

    Possible answers on a 5-pt-Likert-scale ranging from "completely disagree" = 1pt to "completely agree" = 5pts possible minimum score 4pts, possible maximum score 20pts with higher scores meaning a better outcome

    Measured: 20 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2021
  2. Study start19 Apr 2021
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion30 Apr 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Sequential
Model description
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).
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04778384
Sponsor's protocol ID
Intervention_Pain_Therapy
Status last verified
Apr 2021
First submitted
23 Feb 2021
Last updated
11 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32546177

Questions about this trial

What is this clinical trial studying?

A study testing Micro-training to promote self-management in pain therapy in people with Patient Empowerment, run by Luzerner Kantonsspital at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fabia Buettcher, MD (+41 41 205 1344, fabia.buettcher@luks.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in pain-related restriction of daily activities (time frame: 20 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04778384, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in