Pilot Study to Test the Feasibility and the Efficacy of the German Language Adapted PRO-SELF© Plus Pain Control Program

Not Applicable

Completed

• Conditions: Neoplasm Metastasis
• Interventions: Behavioral: German PRO-SELF(c) Plus Pain Control Program (PCP); Other: Standard Care

• Registration Number: NCT00920504
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

The purpose of this pilot study is to refine and test an advanced and adapted German version of the PRO-SELF© Plus Pain Control Program (PCP), an educational intervention directed at cancer pain patients and their families to enhance their pain self management abilities, and to calculate effect sizes for the planning of a sufficiently powered randomized controlled trial (RCT).

Detailed Description

Background: Cancer patients experience multiple symptoms throughout the different stages of their illness, with pain as one of the most frequent. Even though effective treatment options exist, more than 40% of all cancer pain patients do not receive adequate pain management. For pain control, in addition to state of the art treatment by professionals, patients and their family caregivers (FCs) have to use self care strategies on a daily basis, a complex process that profits from targeted support by health care providers (HCPs). In phase 1 of this study, the intervention and the study instruments have been translated, adapted and advanced.

Aims: The purpose of this pilot study is to refine and test an advanced and adapted German version of the PRO-SELF© Plus Pain Control Program (PCP), an educational intervention directed at cancer pain patients and their families to enhance their pain self management abilities, and to calculate effect sizes for the planning of a sufficiently powered randomized controlled trial (RCT).

Methods: The advanced and adapted German version of the PRO-SELF© Plus PCP will be tested in a pilot RCT in cancer patients with pain from bone metastasis, compared with standard care, with effect sizes being calculated for the planning of a sufficiently powered RCT. A qualitative sub study will explore patients' and FCs' experiences with pain management, with the educational intervention, and their view of burden and benefit from study participation.

Intervention: The PRO-SELF© Plus PCP is based on three key strategies: (a) provision of information, (b) skill building, and (c) nurse coaching. The 10-week educational program comprises a structured part (teaching of pain management skills including the use of a weekly pillbox, the use of a pain management diary and written instructions on how to communicate with the physician about unrelieved pain) and a tailored part. The patient's answers on questions about his knowledge of pain management serve as basis for tailoring the teaching (academic detailing).

Data analysis: Main outcome variables will be average and worst pain as reported daily by the patient. In order to determine effect sizes for main effect of group, main effect of time and the group by time interaction a repeated measure longitudinal design will be used employing a linear mixed model approach. For the qualitative part, interviews will be analyzed using content analysis.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-12
• Study First Submitted QC: 2009-06-12
• Study First Posted: 2009-06-15
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-08
• Last Update Posted: 2012-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Outpatients
• with cancer related pain ≥ 3 on a scale of 0-10 during the last two weeks,
• estimated life expectancy of > 6 months as assessed by the physician,
• 18 years of age or older,
• able to understand, read and write German,
• have access to a telephone,
• live in a 1 hour distance around Freiburg or are willing to travel to Freiburg for each visit, agree to participate and give written in-formed consent

Exclusion Criteria

• documented previous or current psychiatric disorder or cognitive impairment as assessed by the physician (that is, unable to understand and provide informed consent),
• visual or hearing impairment that prevents adequate communication,
• a named FC who is not willing to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
German PRO-SELF(c) Plus PCP	German PRO-SELF(c) Plus Pain Control Program (PCP)	Group receives 10 weeks German PRO-SELF(c) Plus PCP intervention program
Standard Care	German PRO-SELF(c) Plus Pain Control Program (PCP)	control group receives attention control and standard care
Standard Care	Standard Care	control group receives attention control and standard care

Primary Outcome Measures

Name	Time	Method
average and worst pain as reported daily by patients on a scale from 0 (no pain) to 10 (worst imaginable pain)	measured daily for 10 weeks and in week 14 and 22

Secondary Outcome Measures

Name	Time	Method
patients' knowledge of cancer pain management	baseline, week 6, 10, 14 and 22

Trial Locations

Locations (1)

Tumorzentrum Ludwig Heilmeyer Comprehensive Cancer Center Freiburg; 🇩🇪 Freiburg, Germany