Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
167 participants
INTERVENTIONAL
2004-10-31
2008-04-30
Brief Summary
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Detailed Description
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The purpose of the study was to test the effectiveness of The PRO-SELF Pain Control Program in Norwegian cancer patients and their family caregivers. Only data on patient outcomes will be presented.
The theoretical framework for this study incorporated elements of Orem's self-care theory, as well as the principles of academic detailing and nurse coaching to change patients' self-care behaviors regarding cancer pain management.
Two hundred adult cancer patients with pain from skeletal metastasis and their caregivers participated in this study. Patients were randomized to either the PRO-SELF program or standard care. Patients completed questionnaires about pain, physical functioning, quality of life, anxiety, and depression at the time of enrollment and after 6 weeks. Data on analgesics were collected through chart reviews and patient diaries. Both groups received home visits and telephone calls by an oncology nurse over a period of six weeks. Participants in the intervention group received education about pain management and were coached to improve their pain management behaviors. Two-way repeated measures analyses of variance will be done to determine differences in pain intensity scores and to evaluate the differences over time in the total amount of opioid analgesics taken by the patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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1
Patients who received the Pro-Self psychoeducational intervention
Pro self pain control programme
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
2
Patients who received standard care
No interventions assigned to this group
Interventions
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Pro self pain control programme
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
Eligibility Criteria
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Inclusion Criteria
* Radiographic evidence of bone metastasis
* Able to read and write Norwegian
* Average pain intensity of greater than 2.5
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Oslo University Hospital
OTHER
Responsible Party
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Oslo University College
Principal Investigators
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Tone Rustoen, PhD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Locations
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Ulleval University Hospital
Oslo, , Norway
Countries
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References
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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.
Other Identifiers
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158707/V10
Identifier Type: -
Identifier Source: org_study_id
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