Improvement of Self Management for Oncologic Patients With Pain

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00779597
• Other study ID #: BMBF-T3
• Secondary ID: Grand No.: 01GT0
• Status: Completed
• Phase: N/A
• First received: October 22, 2008
• Last updated: August 26, 2010
• Start date: October 2008
• Est. completion date: January 2010

Study information

• Verified date: October 2008
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: German Institute of Medical Documentation and Information
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer
• Pain

Intervention

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.

Locations

Country	Name	City	State
Germany	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

Sponsors (1)

Lead Sponsor	Collaborator
Martin-Luther-Universität Halle-Wittenberg

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-related barriers to management of cancer pain (Barriers Questionnaire II)		7 days after discharge	No
Secondary	Average pain intensity score (Brief Pain Inventory)		7th day after discharge	No
Secondary	HRQoL (EORTC QLQ C 30 (Version 3.0))		7th day after discharge	No
Secondary	Adherence to pain medication (MORISKY Adherence Score)		7th day after discharge	No
Secondary	Coping of Pain (FESV-BW)		7th day after discharge	No

External Links

•   Institutional Contact
•   Trial Protocol