Viewing Study NCT00927433



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Last Modification Date: 2024-10-26 @ 10:07 AM
Study NCT ID: NCT00927433
Status: UNKNOWN
Last Update Posted: 2011-06-30
First Post: 2009-06-23

Brief Title: Cancer Patients Knowledge About Fatigue
Sponsor: Oslo University Hospital
Organization: Oslo University Hospital

Study Overview

Official Title: Development and Implementation of a Structured Educational Programme to Increase Patients Knowledge About Fatigue and to Evaluate the Effect of Increased Knowledge on Cancer Patients Experience of Fatigue
Status: UNKNOWN
Status Verified Date: 2011-06
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Background Result from an earlier study I carried out in the late 1990 showed that cancer patients were overall well informed about diagnoses prognoses symptoms treatment side-effects of treatment eg pain nausea and vomiting and hair loss Their knowledge about fatigue as a side -effect to cancer and cancer treatment was however different Patients had minimal knowledge about fatigue and they were not prepared for this side-effect and as a result of this they did not know how to handle fatigue and fatigue was seen as a very frightening experience

As a result of the findings I wanted to carry out an intervention study where the aims were to develop an educational programme about fatigue and to evaluate the effect of the programme

Purpose The purpose of the project is to develop and describe a structured educational programme The structured educational programme will serve as the intervention The purpose is also to evaluate whether or not the structured educational programme increase the cancer patients knowledge about cancer related fatigue and to find out if increased knowledge about cancer related fatigue ease the experience of cancer related fatigue

Another purpose of the study is to investigate the connection between fatigue and other symptoms and to find out how other symptoms influence the patients experience of fatigue

The study will consist of 3 stages

Development of structured educational programme
Implementation of structured educational programme
Evaluation of the effect of the structured educational programme

Materials and methods The study is a randomised experimental design An intervention group and a control group each consisting of 100 Breast Cancer patients Stadium I or II receiving chemotherapy orand radiation therapy after surgery are included in the study On a NR-scale 0-10 the patients had a fatigue score of 25 or more to be included in the study

The intervention is an educational package of 120 minutes x 3 over three weeks The intervention is given in groups of 10 patients Both groups are responding to questionnaires just before the intervention just after the intervention and three months after finishing the intervention The educational package consisted of basic knowledge about fatigue and strategies or techniques for coping with fatigue
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None