ClinicalTrials.gg
Status unknownNCT00927433Updated Jun 30, 2011

Cancer Patients' Knowledge About Fatigue

An interventional study of Psychoeducational intervention for cancer-related fatigue in Cancer and Fatigue, sponsored by Oslo University Hospital. Status unknown. Per ClinicalTrials.gov, last updated 2011-06-30.

Sponsored by Oslo University Hospital · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Jun 2011), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
01

Study 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.

02

Conditions studied

  • Cancer
  • Fatigue

Keywords

  • Fatigue
  • Cancer
  • Radiation therapy
  • Chemotherapy
  • Hormones
  • Surgery
  • Breast cancer
03

In context

Neoplasms

9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.

This study's enrollment of 160 is above the median of 50 across 7,429 interventional studies indexed under Neoplasms.

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Lead sponsor

Oslo University Hospital is the lead sponsor of 830 studies on the registry; 146 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Under the age of 10 years,
  • Not able to read, write or understand Norwegian.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
160 participants (actual)

Study arms

  • No intervention
    Standard care

    Patients received standard education about fatigue by clinicians.

    Behavioral: Psychoeducational intervention for cancer-related fatigue

  • 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

Interventions

  • BehavioralPsychoeducational intervention for cancer-related fatigue

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

    Also known as: Standard care, Educational intervention

06

What researchers measure

Primary outcomes

  1. Level of fatigue

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2007, a primary completion of Mar 2008 and a completion of Dec 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 23, 2009
First posted
Jun 25, 2009
Start
Oct 2007
Primary completionActual
Mar 2008
CompletionEst.
Dec 2011
Last update
Jun 30, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 30, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00927433
First posted
Jun 25, 2009
Start date
Oct 2007
Primary completion
Mar 2008
Completion
Dec 2011 (estimated)
Last update
Jun 30, 2011

Study contacts

Tone Rustøen, PhD
principal investigator · Oslo University College

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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