Know Cancer

forgot password

Improvement of Self Management Skills for Oncologic Patients With Pain Through a Trans Institutional Nursing Intervention: a Cluster Randomized Multi Center Study

18 Years
80 Years
Not Enrolling
Pain, Cancer

Thank you

Trial Information

Improvement of Self Management Skills for Oncologic Patients With Pain Through a Trans Institutional Nursing Intervention: a Cluster Randomized Multi Center Study

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

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome Time Frame:

7 days after discharge

Safety Issue:


Principal Investigator

Margarete Landenberger, Professor, Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Martin-Luther-University Halle-Wittenberg


Germany: German Institute of Medical Documentation and Information

Study ID:




Start Date:

October 2008

Completion Date:

January 2010

Related Keywords:

  • Pain
  • Cancer
  • self care
  • symptom management
  • pain
  • cancer
  • nurse coaching
  • patient education