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Brief Title: 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 ID: 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.
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University Hospital rechts der Isar, Munich Technical University, Munich, Bavaria, Germany
Martin-Luther-University Halle-Wittenberg, Halle (Saale), Sachsen-Anhalt, Germany
University Hospital Halle, Martin-Luther-University Halle-Wittenberg, Halle (Saale), Sachsen-Anhalt, Germany
Name: Margarete Landenberger, Professor, Dr.
Affiliation: Martin-Luther-University Halle-Wittenberg
Role: PRINCIPAL_INVESTIGATOR
Name: Ingrid Horn
Affiliation: University Hospital Halle, Martin-Luther-University Halle-Wittenberg
Role: STUDY_CHAIR
Name: Anette Thoke-Colberg
Affiliation: University Hospital rechts der Isar, Munich Technical University
Role: STUDY_CHAIR