Improvement of Self Management for Oncologic Patients With Pain

August 26, 2010 updated by: Martin-Luther-Universität Halle-Wittenberg

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

208

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 81664
        • University Hospital rechts der Isar, Munich Technical University
    • Sachsen-Anhalt
      • Halle (Saale), Sachsen-Anhalt, Germany, 06097
        • Martin-Luther-University Halle-Wittenberg
      • Halle (Saale), Sachsen-Anhalt, Germany, 06097
        • University Hospital Halle, Martin-Luther-University Halle-Wittenberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Martin-Luther-Universität Halle-Wittenberg

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

October 22, 2008

First Submitted That Met QC Criteria

October 23, 2008

First Posted (Estimate)

October 24, 2008

Study Record Updates

Last Update Posted (Estimate)

August 27, 2010

Last Update Submitted That Met QC Criteria

August 26, 2010

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BMBF-T3
  • Grand No.: 01GT0601

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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