NCT00920504

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 15, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

February 9, 2012

Status Verified

February 1, 2012

Enrollment Period

2 years

First QC Date

June 12, 2009

Last Update Submit

February 8, 2012

Conditions

Neoplasm Metastasis

Keywords

Mesh: patient education as topicMesh: neoplasmsMesh: medication therapy managementpain self managementsymptom managementeducation of patients with pain from neoplasm metastases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • patients' knowledge of cancer pain management

    baseline, week 6, 10, 14 and 22

Study Arms (2)

German PRO-SELF(c) Plus PCP

EXPERIMENTAL

Group receives 10 weeks German PRO-SELF(c) Plus PCP intervention program

Behavioral: German PRO-SELF(c) Plus Pain Control Program (PCP)

Standard Care

ACTIVE COMPARATOR

control group receives attention control and standard care

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

Interventions

German PRO-SELF(c) Plus Pain Control Program (PCP)BEHAVIORAL

Educational intervention directed at patients and their family caregivers to reduce cancer pain and related symptoms

German PRO-SELF(c) Plus PCPStandard Care
Standard CareOTHER

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.

Standard Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tumorzentrum Ludwig Heilmeyer Comprehensive Cancer Center Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Related Publications (2)

  • 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.

    PMID: 22959603DERIVED

  • 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.

    PMID: 22459260DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Elisabeth Spichiger, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2009

First Posted

June 15, 2009

Study Start

June 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

February 9, 2012

Record last verified: 2012-02

Locations

DE(1)