NCT00760305

Brief Summary

The main aim of this study is to evaluate whether a patient education programme on cancer pain management compared to standard care decreases pain and increases patients quality of life. The investigators hypothesis is that patients and family caregivers who receive the intervention will have improved outcomes. Patients and family members are seen in their homes by the nurses doing the intervention over 6 weeks. Patients keep a diary of their pain and medication intake.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
167

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Oct 2004

Typical duration for not_applicable cancer

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

October 1, 2004

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2008

Completed
Last Updated

May 24, 2011

Status Verified

September 1, 2008

Enrollment Period

3.5 years

First QC Date

September 25, 2008

Last Update Submit

May 23, 2011

Conditions

CancerPain

Keywords

cancer painbone metastasispatient educationpsychoeducational educationside effectsanalgesics

Outcome Measures

Primary Outcomes (1)

  • Worst pain intensity

    6 weeks

Secondary Outcomes (1)

  • Knowledge of cancer pain management

    6 weeks

Study Arms (2)

1

EXPERIMENTAL

Patients who received the Pro-Self psychoeducational intervention

Behavioral: Pro self pain control programme

2

NO INTERVENTION

Patients who received standard care

Interventions

Pro self pain control programmeBEHAVIORAL

A 6 week psychoeducational programme that included three home visits and three phone calls. Patients were taught about pain medication and side effects and about incorrect information regarding cancer pain management

1

Eligibility Criteria

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

You may qualify if:

  • Greater than 18 years of age
  • Radiographic evidence of bone metastasis
  • Able to read and write Norwegian
  • Average pain intensity of greater than 2.5

You may not qualify if:

  • Brain metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ulleval University Hospital

Oslo, Norway

Location

Related Publications (1)

  • Rustoen T, Lerdal A, Gay C, Kottorp A. Rasch analysis of the Herth Hope Index in cancer patients. Health Qual Life Outcomes. 2018 Oct 3;16(1):196. doi: 10.1186/s12955-018-1025-5.

    PMID: 30285767DERIVED

MeSH Terms

Conditions

NeoplasmsPainCancer Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tone Rustoen, PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 25, 2008

First Posted

September 26, 2008

Study Start

October 1, 2004

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

May 24, 2011

Record last verified: 2008-09

Locations

NO(1)