A study to examine the impact of doctor training in how to respond to patient reported symptoms and health related quality of life
ISRCTN | ISRCTN81227579 |
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DOI | https://doi.org/10.1186/ISRCTN81227579 |
Secondary identifying numbers | C7775/A7424 |
- Submission date
- 14/06/2011
- Registration date
- 28/09/2011
- Last edited
- 26/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Prof Galina Velikova
Scientific
Scientific
Level 4, Bexley Wing
St James' Institute of Oncology
Beckett Street
Leeds
LS9 7TF
United Kingdom
Phone | +44 113 206 7917 |
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g.velikova@leeds.ac.uk |
Study information
Study design | Pilot Quasi-experimental study |
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Primary study design | Interventional |
Secondary study design | Non randomised controlled trial |
Study setting(s) | Hospital |
Study type | Screening |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | A pilot quasi-experimental study to examine the impact of doctor training in how to respond to patient reported symptoms and health related quality of life |
Study objectives | Training oncologists to use HRQoL measures during routine chemotherapy review consultations will improve patient-centred communication. The data from this pilot study will provide an estimate of the impact of oncologist training and contribute to sample size calculations for a future randomised controlled trial. |
Ethics approval(s) | Leeds Central Reseach Ethics Committee, 10/02/2011 ref: 11/H1313/2 |
Health condition(s) or problem(s) studied | Advanced stage breast, colorectalcancer, gynaecological cancers |
Intervention | The study utilises a quasi-experimental design (before and after). 30 patients will be invited to take part before the participating oncologists attend the training programme and further 30 patients will be recruited after the training. Patients will be asked to complete a health related quality of life (HRQoL) questionnaire prior to routine chemotherapy review consultations. The participating oncologists (n = 3) will receive the results of the questionnaire and asked to incorporate these into the consultations. The before after study design will be used to assess the impact of a doctor training session to aid the facilitation of the HRQoL questionnaire into consultations. |
Intervention type | Other |
Primary outcome measure | Doctor-patient communication before and after the doctor training will be compared by: 1. Analysing audio-recordings of the consultations using content analysis and the measure of patient centred communication to determine the number of issues raised and the quality of discussions 2. Patient and oncologists views will be assessed using the Patient Perception of Patient Centredness questionnaire and the corresponding measure for doctors |
Secondary outcome measures | Interviews with participating oncologists at the end of the study will explore their experience of the intervention before and after the training and opinions of the training programme to obtain suggestions for improving its content. |
Overall study start date | 04/07/2011 |
Completion date | 28/10/2011 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 60 |
Total final enrolment | 60 |
Key inclusion criteria | 1. Are attending oncology clinics at St James' Institute of Oncology 2. Are receiving anti cancer chemotherapy for advanced stage of disease (breast, colorectal and gynaecological cancer) 3. Are able to give informed consent 4. Are able to read and understand English |
Key exclusion criteria | 1. Are below 18 years of age 2. Show overt exhibition of psychopathology or serious cognitive dysfunction which would impede them being able to take part in the study 3. Are deemed too ill by the oncology staff |
Date of first enrolment | 04/07/2011 |
Date of final enrolment | 28/10/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Level 4, Bexley Wing
Leeds
LS9 7TF
United Kingdom
LS9 7TF
United Kingdom
Sponsor information
University of Leeds (UK)
University/education
University/education
School of Medicine
The Worsley Medical & Dental Building
Clarendon Way
Leeds
LS2 9NL
England
United Kingdom
Phone | +44 113 343 0900 |
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R.E.DeSouza@leeds.ac.uk | |
Website | http://www.leeds.ac.uk/ |
https://ror.org/024mrxd33 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK) ref: C7775/A7424
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan | Not provided at time of registration |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/07/2015 | Yes | No | |
Plain English results | 26/10/2022 | No | Yes |
Editorial Notes
25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
30/04/2018: Publication reference added.
09/03/2016: No publications found, verifying study status with principal investigator.