Improvement of Self Management for Oncologic Patients With Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Care as usual

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No