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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
Switzerland1 site, 1 recruiting
- 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
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.
- Conditions
- Patient Empowerment
- 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 group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: Other: Sham intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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.
- First posted3 Mar 2021
- Study start19 Apr 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient EmpowermentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabia Buettcher, MD, Study chair, Luzerner Kantonsspital
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a Patient Education for Oncological Patients to Promote Self-management in Pain Therapy
- ClinicalTrials.gov ID
- NCT04778384
- Acronym / sponsor ID
- Intervention_Pain_Therapy
- Conditions
- Patient Empowerment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Micro-training to promote self-management in pain therapy30 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) |
| Control Group | Sham comparator | Other: Sham intervention30 patients receive a sham intervention: an unstructured conversation is carried out. Patient questions are answered correctly, but there is no training, rather patient information. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Oncology clinics outpatients with parenteral therapy with a new or escalated opioid pain therapy without exclusion criteria
Key exclusion criteria (3 listed)
- Lack of consent
- Insufficient knowledge of German
- Cognitive deficits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micro-training to promote self-management in pain therapyMicro-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. | Behavioural | Intervention Group |
| Sham interventionAn unstructured conversation is carried out. Patient questions are answered correctly, but there is no training, rather patient information. | Other | Control Group |
Primary outcome
Change in pain-related restriction of daily activities
Time frame: 20 months
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
2 secondary outcomes
Change in patient-related barriers
Time frame: 20 months
Confidence in handling pain medication, satisfaction with pain therapy and quality of life, restriction of the most important activities in everyday life
Time frame: 20 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Background: PubMed 32546177Raphaelis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabia Buettcher, MD study chair
Luzerner Kantonsspital
1 site in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 8 Nov 2026.