Improvement of Self Management for Oncologic Patients With Pain

This study has been completed.
Sponsor:
Information provided by:
Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier:
NCT00779597
First received: October 22, 2008
Last updated: August 26, 2010
Last verified: October 2008
  Purpose

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.


Condition Intervention
Pain
Cancer
Behavioral: SCION (Self care improvement through oncology nursing)-PAIN program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Improvement of Self Management Skills for Oncologic Patients With Pain Through a Trans Institutional Nursing Intervention: a Cluster Randomized Multi Center Study

Resource links provided by NLM:


Further study details as provided by Martin-Luther-Universität Halle-Wittenberg:

Primary Outcome Measures:
  • Patient-related barriers to management of cancer pain (Barriers Questionnaire II) [ Time Frame: 7 days after discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average pain intensity score (Brief Pain Inventory) [ Time Frame: 7th day after discharge ] [ Designated as safety issue: No ]
  • HRQoL (EORTC QLQ C 30 (Version 3.0)) [ Time Frame: 7th day after discharge ] [ Designated as safety issue: No ]
  • Adherence to pain medication (MORISKY Adherence Score) [ Time Frame: 7th day after discharge ] [ Designated as safety issue: No ]
  • Coping of Pain (FESV-BW) [ Time Frame: 7th day after discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 208
Study Start Date: October 2008
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00779597

Locations
Germany
University Hospital rechts der Isar, Munich Technical University
Munich, Bavaria, Germany, 81664
Martin-Luther-University Halle-Wittenberg
Halle (Saale), Sachsen-Anhalt, Germany, 06097
University Hospital Halle, Martin-Luther-University Halle-Wittenberg
Halle (Saale), Sachsen-Anhalt, Germany, 06097
Sponsors and Collaborators
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
  More Information

Additional Information:
Publications:
Responsible Party: Margarete Landenberger, Professor, Dr. phil. habil., Martin-Luther-University Halle-Wittenberg Medical Faculty, Department for Health and Nursing Science
ClinicalTrials.gov Identifier: NCT00779597     History of Changes
Other Study ID Numbers: BMBF-T3, Grand No.: 01GT0601
Study First Received: October 22, 2008
Last Updated: August 26, 2010
Health Authority: Germany: German Institute of Medical Documentation and Information

Keywords provided by Martin-Luther-Universität Halle-Wittenberg:
self care
symptom management
pain
cancer
nurse coaching
patient education

ClinicalTrials.gov processed this record on October 23, 2014