Cancer Patients' Knowledge About Fatigue

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Oslo University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00927433
First received: June 23, 2009
Last updated: June 29, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Cancer
Fatigue
Behavioral: Psychoeducational intervention for cancer-related fatigue

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
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

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Level of fatigue [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 160
Study Start Date: October 2007
Estimated Study Completion Date: December 2011
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard care
Patients received standard education about fatigue by clinicians.
Behavioral: 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
Other Names:
  • Standard care
  • Educational intervention
Experimental: Education arm
Patients received education on fatigue management in groups of ten patients over two weeks in three two hour sessions.
Behavioral: 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
Other Names:
  • Standard care
  • Educational intervention

  Eligibility

Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927433

Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Tone Rustøen, PhD Oslo University College
  More Information

No publications provided

Responsible Party: Tone Rustøen, Rikshospitalet HF
ClinicalTrials.gov Identifier: NCT00927433     History of Changes
Other Study ID Numbers: Intervention, cancer fatigue
Study First Received: June 23, 2009
Last Updated: June 29, 2011
Health Authority: Norway: Data Protection Authority

Keywords provided by Oslo University Hospital:
Fatigue
Cancer
Radiation therapy
Chemotherapy
Hormones
Surgery
Breast cancer

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014