Clinical trial NCT00920504: Pilot Study to Test the Feasibility and the Efficacy of the German Language Adapted PRO-SELF© Plus Pain Control Program
Official title: Pilot Study to Test the Feasibility and the Efficacy of the German Language Adapted PRO-SELF© Plus Pain Control Program, an Educational Intervention Directed at Patients and Their Family Caregivers to Reduce Cancer Pain and Related Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasm Metastasis
Keywords: Mesh: patient education as topic
Mesh: neoplasms
Mesh: medication therapy management
pain self management
symptom management
education of patients with pain from neoplasm metastases
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: University of Basel
name: University Hospital Freiburg
name: University of California, San Francisco
First posted: 2009-06-15
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: average and worst pain as reported daily by patients on a scale from 0 (no pain) to 10 (worst imaginable pain)
timeFrame: measured daily for 10 weeks and in week 14 and 22
Secondary outcomes:
measure: patients' knowledge of cancer pain management
timeFrame: baseline, week 6, 10, 14 and 22
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Tumorzentrum Ludwig Heilmeyer Comprehensive Cancer Center Freiburg
Study officials:
affiliation: Institute of Nursing Science, Faculty of Medicine, University of Basel, Switzerland
name: Elisabeth Spichiger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koller A, Miaskowski C, De Geest S, Opitz O, Spichiger E. Results of a randomized controlled pilot study of a self-management intervention for cancer pain. Eur J Oncol Nurs. 2013 Jun;17(3):284-91. doi: 10.1016/j.ejon.2012.08.002. Epub 2012 Sep 4.
citation: Koller A, Miaskowski C, De Geest S, Opitz O, Spichiger E. Supporting self-management of pain in cancer patients: methods and lessons learned from a randomized controlled pilot study. Eur J Oncol Nurs. 2013 Feb;17(1):1-8. doi: 10.1016/j.ejon.2012.02.006. Epub 2012 Mar 28.