Improvement of Self Management for Oncologic Patients With Pain

Martin-Luther-Universität Halle-Wittenberg

Status: Completed

Conditions: Cancer; Pain

Treatments: Behavioral: SCION (Self care improvement through oncology nursing)-PAIN program

Study type: Interventional

Funder types: Other

Identifiers

NCT00779597

BMBF-T3

Grand No.: 01GT0601

Details and patient eligibility

About

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.

Full 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.

Enrollment: 208 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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208 participants in 2 patient groups

Care as usual

No Intervention group

Description:

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

SCION-PAIN program

Experimental group

Description:

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.

Treatment:

Behavioral: SCION (Self care improvement through oncology nursing)-PAIN program