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

NCT00920504 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2012-02-09

No results posted yet for this study

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).

Conditions

  • Neoplasm Metastasis

Interventions

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.

Sponsors & Collaborators

  • University of Basel

    collaborator OTHER

  • University Hospital Freiburg

    collaborator OTHER

  • University of California, San Francisco

    collaborator OTHER

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Elisabeth Spichiger, PhD · Institute of Nursing Science, Faculty of Medicine, University of Basel, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00920504 on ClinicalTrials.gov