NCT00779597

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Oct 2008

Typical duration for not_applicable pain

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

August 27, 2010

Status Verified

October 1, 2008

Enrollment Period

1.2 years

First QC Date

October 22, 2008

Last Update Submit

August 26, 2010

Conditions

PainCancer

Keywords

self caresymptom managementpaincancernurse coachingpatient education

Outcome Measures

Primary Outcomes (1)

  • Patient-related barriers to management of cancer pain (Barriers Questionnaire II)

    7 days after discharge

Secondary Outcomes (4)

  • 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

Study Arms (2)

Care as usual

NO INTERVENTION

Care as usual, i.e. standard pain treatment and standard care

SCION-PAIN program

EXPERIMENTAL

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

Interventions

SCION (Self care improvement through oncology nursing)-PAIN programBEHAVIORAL

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.

SCION-PAIN program

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Hospital rechts der Isar, Munich Technical University

Munich, Bavaria, 81664, Germany

Location

Martin-Luther-University Halle-Wittenberg

Halle, Saxony-Anhalt, 06097, Germany

Location

University Hospital Halle, Martin-Luther-University Halle-Wittenberg

Halle, Saxony-Anhalt, 06097, Germany

Location

Related 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.

    PMID: 20307262BACKGROUND

Related Links

MeSH Terms

Conditions

PainNeoplasms

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Margarete Landenberger, Professor, Dr.

    Martin-Luther-University Halle-Wittenberg

    PRINCIPAL INVESTIGATOR

  • Ingrid Horn

    University Hospital Halle, Martin-Luther-University Halle-Wittenberg

    STUDY CHAIR

  • Anette Thoke-Colberg

    University Hospital rechts der Isar, Munich Technical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 22, 2008

First Posted

October 24, 2008

Study Start

October 1, 2008

Primary Completion

December 1, 2009

Study Completion

January 1, 2010

Last Updated

August 27, 2010

Record last verified: 2008-10

Locations

DE(3)