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Cancer Patients' Knowledge About Fatigue

NCT ID: NCT00927433

Last Updated: 2011-06-30

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2011-12-31

Brief Summary

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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 e.g. 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 or/and radiation therapy after surgery are included in the study. On a NR-scale (0-10) the patients had a fatigue score of 2,5 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

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Conditions

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Cancer Fatigue

Keywords

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Fatigue Cancer Radiation therapy Chemotherapy Hormones Surgery Breast cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Standard care

Patients received standard education about fatigue by clinicians.

Group Type NO_INTERVENTION

Psychoeducational intervention for cancer-related fatigue

Intervention Type BEHAVIORAL

Patients received education on fatigue management in groups of ten patients over two weeks in three two hour sessions

Education arm

Patients received education on fatigue management in groups of ten patients over two weeks in three two hour sessions.

Group Type EXPERIMENTAL

Psychoeducational intervention for cancer-related fatigue

Intervention Type BEHAVIORAL

Patients received education on fatigue management in groups of ten patients over two weeks in three two hour sessions

Interventions

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Psychoeducational intervention for cancer-related fatigue

Patients received education on fatigue management in groups of ten patients over two weeks in three two hour sessions

Intervention Type BEHAVIORAL

Other Intervention Names

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Standard care Educational intervention

Eligibility Criteria

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Inclusion Criteria

* Women with breast cancer stage I or II.
* Fatigue score more than 2.5 on a NRS (O-10).
* Give written consent.

Exclusion Criteria

* Under the age of 10 years,
* Not able to read, write or understand Norwegian.
Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rikshospitalet HF

Principal Investigators

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Tone Rustøen, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University College

Other Identifiers

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Intervention, cancer fatigue

Identifier Type: -

Identifier Source: org_study_id