Skip to main content
OpenTrials
Completed

NCT Number: NCT00779597

Improvement of Self Management for Oncologic Patients With Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital rechts der Isar, Munich Technical University, Munich, Bavaria, Germany

Loading trial locations.

About this 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 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

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

    Time frame: 7 days after discharge

Secondary outcomes

  1. Average pain intensity score (Brief Pain Inventory)

    Time frame: 7th day after discharge

  2. HRQoL (EORTC QLQ C 30 (Version 3.0))

    Time frame: 7th day after discharge

  3. Adherence to pain medication (MORISKY Adherence Score)

    Time frame: 7th day after discharge

  4. Coping of Pain (FESV-BW)

    Time frame: 7th day after discharge

Sponsors and collaborators

Lead sponsor

Martin-Luther-Universität Halle-Wittenberg

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Oct 24, 2008
Registry last updated
Aug 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.