Plain English Summary
Background and study aims
Fatigue (extreme tiredness) is one of the most common side effects in cancer patients. Not only does the disease itself cause symptoms of fatigue, but the aggressive treatments such as chemotherapy and radiotherapy can make them particularly wsevere. Cancer-related fatigue (CRF) is extremely common but not routinely screened for, assessed, or treated during the symptom management of cancer patients. Currently, a growing and persuasive body of evidence on CRF is accumulating. This study is about how to integrate the evidence into the CRF routine care and eventually improve the CRF nursing quality. The aim of this study is to investigate the effectiveness of an evidence-based nursing practice model of cancer-related fatigue (CRF) management in hospitalized adult patients, using the Promoting Action on Research Implementation in Health Services (PARIHS) framework.
Who can participate?
Nurses working in cancer units of the university-affiliated adult hospital in Suzhou between May to September 2015 and patients admitted to those units who have cancer related fatigue.
What does the study involve?
Nurses undergo training in the cancer-related fatigue (CRF) management programme as part of standard practice. This involves learning how to implement the strategy with patients. At the start of the study and then after the programme has been implemented, nurses complete a range of questionnaires designed to measure their knowledge, attitudes and behaviors regarding CRF. In additions, patients being treated on the wards also complete a number of questionnaires designed to measure their CRF self-management ability.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating in this study.
Where is the study run from?
First Affiliated Hospital of Soochow University (China)
When is the study starting and how long is it expected to run for?
February 2014 to September 2015
Who is funding the study?
Suzhou Science and Technology Development Project (China)
Who is the main contact?
Dr Li Tian
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Implementation of evidence into practice for cancer-related fatigue management of hospitalized adult patients using the PARIHS framework
Acronym
Study hypothesis
The aim of this study is to explore an evidence-based nursing practice model of cancer-related fatigue (CRF) management in hospitalized adult patients, using the Promoting Action on Research Implementation in Health Services (PARIHS) evidence-implementation framework as the theoretical structure, to provide guidance for similar nursing practices.
Ethics approval
Medical ethics committee, First Affiliated Hospital of Soochow University, 25/03/2014, ref: 2014-147
Study design
Observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cancer-related fatigue (CRF)
Intervention
Nurses undergo training on the evidence and procedure to be implemented as part of standard practice. This involves concept of evidence-based nursing; the necessity for CRF EBN practice implementation; the content, source, quality, and strength of the evidence recommendations; the related practice procedures to be implemented; the assessment tools to be used; and the quality review standards of CRF nursing practice.
At baseline and after the implementation at the admission of the next treatment cycle that following the implementation , patients complete a number of questionnaires designed to measure their CRF self-management ability and the changes in CRF scaling. In addition, nurses also complete questionnaires designed to measure their knowledge, attitudes and behaviors regarding CRF.
Intervention type
Phase
Drug names
Primary outcome measure
1. Nurses’ experiences and insights are collected using the in-depth individual face-to-face semi-structured interviews at the end of the implementation in September 2015
2. Nurses’ knowledge, attitudes and behaviors regarding CRF (NKAB-F) are measured using a survey designed for the purpose of this study at baseline and at the end of the end of the implementation
3. Patients’ CRF self-management ability is measured using the CRF self-management scale and self-efficacy questionnaire for CRF management (SQFM) at baseline and at the admission of the next treatment cycle that following the implementation
4. Patients’ CRF scores are evaluated daily by the nurses during their hospitalization using 0-10 scale. After the discharge, patients assess the CRF scores themselves daily and are required to record it in their CRF diaries
Secondary outcome measures
Research setting’s nursing standards, regulations and procedures are collected using interviews at baseline and at the end of the implementation.
Overall trial start date
08/02/2014
Overall trial end date
30/09/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Nurses:
1. Working in the departments of medical oncology and radiotherapy of a university-affiliated adult hospital in Suzhou between May to September 2015
2. Willing to participate
Patients:
1. Admitted to the departments of medical oncology and radiotherapy of a university-affiliated adult hospital in Suzhou from May to September 2015
2. Diagnosed as having cancer related fatigue
3. Willing to participate
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
at least 30 participants
Participant exclusion criteria
Refusal to participate.
Recruitment start date
10/07/2015
Recruitment end date
10/08/2015
Locations
Countries of recruitment
China
Trial participating centre
First Affiliated Hospital of Soochow University
No.188 Shizi Street
Suzhou
215006
China
Funders
Funder type
Other
Funder name
Suzhou Science and Technology Development Project
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a peer reviewed journal.
IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from sdfyytl@163.com
Intention to publish date
31/12/2017
Participant level data
Available on request
Basic results (scientific)
Publication list