Clinical trial NCT00779597: Improvement of Self Management for Oncologic Patients With Pain
Official title: Improvement of Self Management Skills for Oncologic Patients With Pain Through a Trans Institutional Nursing Intervention: a Cluster Randomized Multi Center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Cancer
Keywords: self care
symptom management
pain
cancer
nurse coaching
patient education
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
First posted: 2008-10-24
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Patient-related barriers to management of cancer pain (Barriers Questionnaire II)
timeFrame: 7 days after discharge
Secondary outcomes:
measure: Average pain intensity score (Brief Pain Inventory)
timeFrame: 7th day after discharge
measure: HRQoL (EORTC QLQ C 30 (Version 3.0))
timeFrame: 7th day after discharge
measure: Adherence to pain medication (MORISKY Adherence Score)
timeFrame: 7th day after discharge
measure: Coping of Pain (FESV-BW)
timeFrame: 7th day after discharge
Other outcomes:
Locations:
city: Munich
country: Germany
facility: University Hospital rechts der Isar, Munich Technical University
state: Bavaria
city: Halle (Saale)
country: Germany
facility: Martin-Luther-University Halle-Wittenberg
state: Sachsen-Anhalt
city: Halle (Saale)
country: Germany
facility: University Hospital Halle, Martin-Luther-University Halle-Wittenberg
state: Sachsen-Anhalt
Study officials:
affiliation: Martin-Luther-University Halle-Wittenberg
name: Margarete Landenberger, Professor, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Halle, Martin-Luther-University Halle-Wittenberg
name: Ingrid Horn
role: STUDY_CHAIR
affiliation: University Hospital rechts der Isar, Munich Technical University
name: Anette Thoke-Colberg
role: STUDY_CHAIR
References:
citation: 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.