Cancer Clinical Trial
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
| Verified date | June 2011 |
| Source | Oslo University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Norway: Data Protection Authority |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 160 |
| Est. completion date | December 2011 |
| Est. primary completion date | March 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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. |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Oslo University Hospital |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Level of fatigue | 6 months | Yes |
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