PainNCT00779597
Improvement of Self Management for Oncologic Patients With Pain
A study testing SCION (Self care improvement through oncology nursing)-PAIN program in people with Pain and Cancer, run by Martin-Luther-Universität Halle-Wittenberg at 3 sites in Germany.
Trial summary
This study will test the SCION (Self care improvement through oncology nursing)-PAIN program, a multi-modular structured intervention to improve self management in oncologic patients with pain compared to care as usual (standard pain treatment and standard care). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- SCION (Self care improvement through oncology nursing)-PAIN program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 3 sitesGermany
- Study dates
- Oct 2008to Jan 2010
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult oncology patients
- able to read, write, and understand German
- agree to participate and give informed consent
- have an average pain intensity score of > 3.0 on a 0 to 10 NRS
- pain persists for more than 3 days
- scheduled for another visit to the clinic
Who cannot join
- documented actual alcohol or drug abuse
- surgery within the last 3 days
- disorientated to date, place and situation
- have a ECOG Performance Score of 4
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Martin-Luther-University Halle-Wittenberg
Halle, Saxony-Anhalt, 06097
University Hospital Halle, Martin-Luther-University Halle-Wittenberg
Halle, Saxony-Anhalt, 06097
University Hospital rechts der Isar, Munich Technical University
Munich, Bavaria, 81664
About this study
Official title: Improvement of Self Management Skills for Oncologic Patients With Pain Through a Trans Institutional Nursing Intervention: a Cluster Randomized Multi Center Study
This study will test the SCION (Self care improvement through oncology nursing)-PAIN program, a multi-modular structured intervention to improve self management in oncologic patients with pain compared to care as usual (standard pain treatment and standard care). The study will determine if the self management skills of the patients continue to be used when the intervention stops, e.g. after discharge from hospital.
It is hypothesized that patients who receive the multi-modular structured intervention will have less patient-related barriers to the management of cancer pain.
Read the detailed description
According to modified "Precede Model of health behavior" from Green, patients self management skills are affected by the patients' knowledge, activities and attitude to pain management.
Therefore, we conduct a cluster randomized clinical trial (C-RCT) that will test the effectiveness of SCION-PAIN program against care as usual on self pain management of the patient and average pain level.
As allocation to intervention or control is performed on the level of wards, randomization is stratified by ward profile (e.g. gynaecological, haematological, urological).
Wards were included if they agreed to participate and had more than 10% patients with a diagnosis of cancer in 2006. Wards with a pediatric profile were excluded.
Adult oncology patients with persistent pain will be recruited by the nurses of the participating wards under the guidance of a research nurse. Patients are included in the trial if they meet the inclusion criteria and sign informed consent. They will receive the intervention that the respective ward was allocated to.
The SCION-PAIN program as a multi modular structured nursing intervention (see Arm Description) will be conducted by specially trained ward nurses in cooperation with the research nurse. The intervention will include components of knowledge, skills training, and coaching (particularly against patient-related barriers to pain medication) to improve cancer pain management. Patients in intervention group will receive follow-up telephone counseling within 2 to 3 days after discharge. The self management skills of the patients will be observed up to 28 days post discharge. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes.
- Being tested
- SCION (Self care improvement through oncology nursing)-PAIN program
- Keywords
- self care, symptom management, pain, cancer, nurse coaching, patient education
- Medical subject headings
- Pain, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCION (Self care improvement through oncology nursing)-PAIN programBehavioural
The intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve self care regarding pain management beginning with admission followed by booster session every third day and one follow up telephone counseling within 3 to 4 days after discharge from hospital.
| Study group | Role | What they receive |
|---|---|---|
| Care as usual | No intervention | Care as usual, i.e. standard pain treatment and standard care |
| SCION-PAIN program | Experimental | SCION-PAIN program - Additionally to standard pain treatment, patients from the intervention wards received, the SCION-PAIN program consisting of 3 modules: pharmacologic pain management, non-pharmacologic pain management and discharge management. Receives: Behavioral: SCION (Self care improvement through oncology nursing)-PAIN program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-related barriers to management of cancer pain (Barriers Questionnaire II)
Measured: 7 days after discharge
Secondary outcomes (4)
Average pain intensity score (Brief Pain Inventory)
Measured: 7th day after discharge
HRQoL (EORTC QLQ C 30 (Version 3.0))
Measured: 7th day after discharge
Adherence to pain medication (MORISKY Adherence Score)
Measured: 7th day after discharge
Coping of Pain (FESV-BW)
Measured: 7th day after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2009
- Study completionJan 2010
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 PainStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Investigators
- Margarete Landenberger, Professor, Dr., Principal investigator, Martin-Luther-University Halle-WittenbergIngrid Horn, Study chair, University Hospital Halle, Martin-Luther-University Halle-WittenbergAnette Thoke-Colberg, Study chair, University Hospital rechts der Isar, Munich Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00779597
- Sponsor's protocol ID
- BMBF-T3
- Other IDs
- Grand No.: 01GT0601
- Status last verified
- Oct 2008
- First submitted
- 22 Oct 2008
- Last updated
- 27 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Jahn P, Kitzmantel M, Renz P, Kukk E, Kuss O, Thoke-Colberg A, Horn I, Landenberger M. Improvement of pain related self management for oncologic patients through a trans institutional modular nursing intervention: protocol of a cluster randomized multicenter trial. Trials. 2010 Mar 22;11:29. doi: 10.1186/1745-6215-11-29.
PubMed 20307262
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Self Management Skills for Oncologic Patients With Pain Through a Trans Institutional Nursing Intervention: a Cluster Randomized Multi Center Study
- ClinicalTrials.gov ID
- NCT00779597
- Acronym / sponsor ID
- BMBF-T3
- Keywords
- self care, symptom management, pain, cancer, nurse coaching, patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 24 Oct 2008 (estimated)
- 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.
This study will test the SCION (Self care improvement through oncology nursing)-PAIN program, a multi-modular structured intervention to improve self management in oncologic patients with pain compared to care as usual (standard pain treatment and standard care). The study will determine if the self management skills of the patients continue to be used when the intervention stops, e.g. after discharge from hospital.
It is hypothesized that patients who receive the multi-modular structured intervention will have less patient-related barriers to the management of cancer pain.
Detailed description
According to modified "Precede Model of health behavior" from Green, patients self management skills are affected by the patients' knowledge, activities and attitude to pain management.
Therefore, we conduct a cluster randomized clinical trial (C-RCT) that will test the effectiveness of SCION-PAIN program against care as usual on self pain management of the patient and average pain level.
As allocation to intervention or control is performed on the level of wards, randomization is stratified by ward profile (e.g. gynaecological, haematological, urological).
Wards were included if they agreed to participate and had more than 10% patients with a diagnosis of cancer in 2006. Wards with a pediatric profile were excluded.
Adult oncology patients with persistent pain will be recruited by the nurses of the participating wards under the guidance of a research nurse. Patients are included in the trial if they meet the inclusion criteria and sign informed consent. They will receive the intervention that the respective ward was allocated to.
The SCION-PAIN program as a multi modular structured nursing intervention (see Arm Description) will be conducted by specially trained ward nurses in cooperation with the research nurse. The intervention will include components of knowledge, skills training, and coaching (particularly against patient-related barriers to pain medication) to improve cancer pain management. Patients in intervention group will receive follow-up telephone counseling within 2 to 3 days after discharge. The self management skills of the patients will be observed up to 28 days post discharge. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care as usual | No intervention | –Care as usual, i.e. standard pain treatment and standard care |
| SCION-PAIN program | Experimental | Behavioral: SCION (Self care improvement through oncology nursing)-PAIN programSCION-PAIN program - Additionally to standard pain treatment, patients from the intervention wards received, the SCION-PAIN program consisting of 3 modules: pharmacologic pain management, non-pharmacologic pain management and discharge management. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- adult oncology patients
- able to read, write, and understand German
- agree to participate and give informed consent
- have an average pain intensity score of > 3.0 on a 0 to 10 NRS
- pain persists for more than 3 days
Key exclusion criteria (4 listed)
- documented actual alcohol or drug abuse
- surgery within the last 3 days
- disorientated to date, place and situation
- have a ECOG Performance Score of 4
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 |
|---|---|---|
| SCION (Self care improvement through oncology nursing)-PAIN programThe intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve self care regarding pain management beginning with admission followed by booster session every third day and one follow up telephone counseling within 3 to 4 days after discharge from hospital. | Behavioural | SCION-PAIN program |
Primary outcome
Patient-related barriers to management of cancer pain (Barriers Questionnaire II)
Time frame: 7 days after discharge
4 secondary outcomes
Average pain intensity score (Brief Pain Inventory)
Time frame: 7th day after discharge
HRQoL (EORTC QLQ C 30 (Version 3.0))
Time frame: 7th day after discharge
Adherence to pain medication (MORISKY Adherence Score)
Time frame: 7th day after discharge
Coping of Pain (FESV-BW)
Time frame: 7th day after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2010.
- Background: PubMed 20307262Jahn P, Kitzmantel M, Renz P, Kukk E, Kuss O, Thoke-Colberg A, Horn I, Landenberger M. Improvement of pain related self management for oncologic patients through a trans institutional modular nursing intervention: protocol of a cluster randomized multicenter trial. Trials. 2010 Mar 22;11:29. doi: 10.1186/1745-6215-11-29.
- Trial ProtocolLink provided by the sponsor.
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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.
Margarete Landenberger, Professor, Dr. principal investigator
Martin-Luther-University Halle-Wittenberg
Ingrid Horn study chair
University Hospital Halle, Martin-Luther-University Halle-Wittenberg
Anette Thoke-Colberg study chair
University Hospital rechts der Isar, Munich Technical University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCION (Self care improvement through oncology nursing)-PAIN program in people with Pain and Cancer, run by Martin-Luther-Universität Halle-Wittenberg at 3 sites in Germany.
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 27 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-related barriers to management of cancer pain (Barriers Questionnaire II) (time frame: 7 days after discharge). 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 NCT00779597, 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 27 Aug 2010.