Evidence-based practice of cancer-related fatigue management
| ISRCTN | ISRCTN71203132 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71203132 |
| Secondary identifying numbers | N/A |
- Submission date
- 11/11/2016
- Registration date
- 23/11/2016
- Last edited
- 22/11/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
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
Contact information
Scientific
Nursing school
Soochow University
No. 1 Shizi Street
Suzhou
215006
China
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Implementation of evidence into practice for cancer-related fatigue management of hospitalized adult patients using the PARIHS framework |
| Study objectives | 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(s) | Medical ethics committee, First Affiliated Hospital of Soochow University, 25/03/2014, ref: 2014-147 |
| Health condition(s) or problem(s) studied | 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 | |
| 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 study start date | 08/02/2014 |
| Completion date | 30/09/2015 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | at least 30 participants |
| Key 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 |
| Key exclusion criteria | Refusal to participate. |
| Date of first enrolment | 10/07/2015 |
| Date of final enrolment | 10/08/2015 |
Locations
Countries of recruitment
- China
Study participating centre
Suzhou
215006
China
Sponsor information
University/education
No. 305 Fenglin Road
Shanghai
200032
China
"ROR" |
https://ror.org/013q1eq08 |
|---|
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 |
