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

This study has been completed.
Sponsor:
Collaborators:
University of Basel
University Hospital Freiburg
University of California, San Francisco
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00920504
First received: June 12, 2009
Last updated: February 8, 2012
Last verified: February 2012
History of Changes
  Purpose

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).


Condition Intervention
Neoplasm Metastasis
 Behavioral: German PRO-SELF(c) Plus Pain Control Program (PCP)
Other: Standard Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Caregivers
U.S. FDA Resources

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • average and worst pain as reported daily by patients on a scale from 0 (no pain) to 10 (worst imaginable pain) [ Time Frame: measured daily for 10 weeks and in week 14 and 22 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • patients' knowledge of cancer pain management [ Time Frame: baseline, week 6, 10, 14 and 22 ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: June 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: German PRO-SELF(c) Plus PCP
Group receives 10 weeks German PRO-SELF(c) Plus PCP intervention program
 Behavioral: German PRO-SELF(c) Plus Pain Control Program (PCP)
Educational intervention directed at patients and their family caregivers to reduce cancer pain and related symptoms
Active Comparator: Standard Care
control group receives attention control and standard care
 Behavioral: German PRO-SELF(c) Plus Pain Control Program (PCP)
Educational intervention directed at patients and their family caregivers to reduce cancer pain and related symptoms
Other: Standard Care
Patients in the standard care group will receive routine care provided by their treating physicians without any further care concerning the PRO-SELF© PCP. Patients in the standard care group will be seen by a research nurse in their homes at weeks 1, 2, 4, 6, 8 and 10 and telephone interviews will be conducted at weeks 3, 5, 7 and 9 but the focus of the visits and phone calls will be data collection only.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00920504

Locations
Germany
Tumorzentrum Ludwig Heilmeyer Comprehensive Cancer Center Freiburg
Freiburg, Germany, 79106
Sponsors and Collaborators
University Hospital, Basel, Switzerland
University of Basel
University Hospital Freiburg
University of California, San Francisco
Investigators
Principal Investigator: Elisabeth Spichiger, PhD Institute of Nursing Science, Faculty of Medicine, University of Basel, Switzerland
  More Information

No publications provided by University Hospital, Basel, Switzerland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00920504     History of Changes
Other Study ID Numbers: PEINCA
Study First Received: June 12, 2009
Last Updated: February 8, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital, Basel, Switzerland:
Mesh: patient education as topic
Mesh: neoplasms
Mesh: medication therapy management
 pain self management
symptom management
education of patients with pain from neoplasm metastases

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013