Improvement of Self Management for Oncologic Patients With Pain
|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: NCT00779597|
Recruitment Status : Completed
First Posted : October 24, 2008
Last Update Posted : August 27, 2010
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.
|Condition or disease||Intervention/treatment|
|Pain Cancer||Behavioral: SCION (Self care improvement through oncology nursing)-PAIN program|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||208 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Improvement of Self Management Skills for Oncologic Patients With Pain Through a Trans Institutional Nursing Intervention: a Cluster Randomized Multi Center Study|
|Study Start Date :||October 2008|
|Primary Completion Date :||December 2009|
|Study Completion Date :||January 2010|
No Intervention: Care as usual
Care as usual, i.e. standard pain treatment and standard care
Experimental: SCION-PAIN program
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.
Behavioral: SCION (Self care improvement through oncology nursing)-PAIN program
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.
- Patient-related barriers to management of cancer pain (Barriers Questionnaire II) [ Time Frame: 7 days after discharge ]
- 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 ]
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): NCT00779597
|University Hospital rechts der Isar, Munich Technical University|
|Munich, Bavaria, Germany, 81664|
|Halle (Saale), Sachsen-Anhalt, Germany, 06097|
|University Hospital Halle, Martin-Luther-University Halle-Wittenberg|
|Halle (Saale), Sachsen-Anhalt, Germany, 06097|
|Principal Investigator:||Margarete Landenberger, Professor, Dr.||Martin-Luther-University Halle-Wittenberg|
|Study Chair:||Ingrid Horn||University Hospital Halle, Martin-Luther-University Halle-Wittenberg|
|Study Chair:||Anette Thoke-Colberg||University Hospital rechts der Isar, Munich Technical University|