Improvement of Self Management for Oncologic Patients With Pain

Not Applicable

Completed

• Conditions: Pain; Cancer
• Interventions: Behavioral: SCION (Self care improvement through oncology nursing)-PAIN program

• Registration Number: NCT00779597
• Lead Sponsor: Martin-Luther-Universität Halle-Wittenberg

Brief 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). 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 Timeline

• Status Verified: 2008-10
• Study Start: 2008-10
• Study First Submitted: 2008-10-22
• Study First Submitted QC: 2008-10-23
• Study First Posted: 2008-10-24
• Primary Completion: 2009-12
• Study Completion: 2010-01
• Last Update Submitted: 2010-08-26
• Last Update Posted: 2010-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SCION-PAIN program	SCION (Self care improvement through oncology nursing)-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.

Primary Outcome Measures

Name	Time	Method
Patient-related barriers to management of cancer pain (Barriers Questionnaire II)	7 days after discharge

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Martin-Luther-University Halle-Wittenberg; 🇩🇪 Halle (Saale), Sachsen-Anhalt, Germany

University Hospital Halle, Martin-Luther-University Halle-Wittenberg; 🇩🇪 Halle (Saale), Sachsen-Anhalt, Germany

University Hospital rechts der Isar, Munich Technical University; 🇩🇪 Munich, Bavaria, Germany