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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


N/A
18 Years
N/A
Not Enrolling
Both
Neoplasm Metastasis

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

average and worst pain as reported daily by patients on a scale from 0 (no pain) to 10 (worst imaginable pain)

Outcome Time Frame:

measured daily for 10 weeks and in week 14 and 22

Safety Issue:

No

Principal Investigator

Elisabeth Spichiger, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institute of Nursing Science, Faculty of Medicine, University of Basel, Switzerland

Authority:

Germany: Ethics Commission

Study ID:

PEINCA

NCT ID:

NCT00920504

Start Date:

June 2009

Completion Date:

June 2011

Related Keywords:

  • Neoplasm Metastasis
  • Mesh: patient education as topic
  • Mesh: neoplasms
  • Mesh: medication therapy management
  • pain self management
  • symptom management
  • education of patients with pain from neoplasm metastases
  • Neoplasms
  • Neoplasm Metastasis

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