Improvement of Self Management for Oncologic Patients With Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improvement of Self Management Skills for Oncologic Patients With Pain Through a Trans Institutional Nursing Intervention: a Cluster Randomized Multi Center Study

Conditions
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Pain, Cancer

Intervention / Treatment
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* Behavioral: SCION (Self care improvement through oncology nursing)-PAIN program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Care as usual<br>Care as usual, i.e. standard pain treatment and standard care | |
| Experimental: SCION-PAIN program<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-related barriers to management of cancer pain (Barriers Questionnaire II) |  | 7 days after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average pain intensity score (Brief Pain Inventory) |  | 7th day after discharge | 
| HRQoL (EORTC QLQ C 30 (Version 3.0)) |  | 7th day after discharge | 
| Adherence to pain medication (MORISKY Adherence Score) |  | 7th day after discharge | 
| Coping of Pain (FESV-BW) |  | 7th day after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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self care, symptom management, pain, cancer, nurse coaching, patient education