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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
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

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

    First Posted
    June 23, 2009
    Last Updated
    June 29, 2011
    Sponsor
    Oslo University Hospital
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    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

    Learn more about this trial

    Cancer Patients' Knowledge About Fatigue

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