Cancer Patients' Knowledge About Fatigue
Primary Purpose
Cancer, Fatigue
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Psychoeducational intervention for cancer-related fatigue
Sponsored by
About this trial
This is an interventional health services research trial for Cancer focused on measuring Fatigue, Cancer, Radiation therapy, Chemotherapy, Hormones, Surgery, Breast cancer
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard care
Education arm
Arm Description
Patients received standard education about fatigue by clinicians.
Patients received education on fatigue management in groups of ten patients over two weeks in three two hour sessions.
Outcomes
Primary Outcome Measures
Level of fatigue
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00927433
Brief Title
Cancer Patients' Knowledge About Fatigue
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Oslo University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Fatigue
Keywords
Fatigue, Cancer, Radiation therapy, Chemotherapy, Hormones, Surgery, Breast cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Patients received standard education about fatigue by clinicians.
Arm Title
Education arm
Arm Type
Experimental
Arm Description
Patients received education on fatigue management in groups of ten patients over two weeks in three two hour sessions.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducational intervention for cancer-related fatigue
Other Intervention Name(s)
Standard care, Educational intervention
Intervention Description
Patients received education on fatigue management in groups of ten patients over two weeks in three two hour sessions
Primary Outcome Measure Information:
Title
Level of fatigue
Time Frame
6 months
10. Eligibility
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tone Rustøen, PhD
Organizational Affiliation
Oslo University College
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Cancer Patients' Knowledge About Fatigue
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